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1.
Lancet ; 400(10361): 1426-1436, 2022 10 22.
Article in English | MEDLINE | ID: mdl-36273481

ABSTRACT

BACKGROUND: Miscarriage in the second trimester and preterm birth are significant global problems. Vaginal cervical cerclage is performed to prevent pregnancy loss and preterm birth. We aimed to determine the effectiveness of a monofilament suture thread compared with braided suture thread on pregnancy loss rates in women undergoing a cervical cerclage. METHODS: C-STICH was a pragmatic, randomised, controlled, superiority trial done at 75 obstetric units in the UK. Women with a singleton pregnancy who received a vaginal cervical cerclage due to a history of pregnancy loss or premature birth, or if indicated by ultrasound, were centrally randomised (1:1) using minimisation to receive a monofilament suture or braided suture thread for their cervical cerclage. Women and outcome assessors were masked to allocation as far as possible. The primary outcome was pregnancy loss, defined as miscarriage, stillbirth, or neonatal death in the first week of life, analysed in the intention-to-treat population (ie, all women who were randomly assigned). Safety was also assessed in the intention-to-treat population. The trial was registered with ISRCTN, ISRCTN15373349. FINDINGS: Between Aug 21, 2015, and Jan 28, 2021, 2049 women were randomly assigned to receive a monofilament suture (n=1025) or braided suture (n=1024). The primary outcome was ascertained in 1003 women in the monofilament suture group and 993 women in the braided suture group. Pregnancy loss occurred in 80 (8·0%) of 1003 women in the monofilament suture group and 75 (7·6%) of 993 women in the braided suture group (adjusted risk ratio 1·05 [95% CI 0·79 to 1·40]; adjusted risk difference 0·002 [95% CI -0·02 to 0·03]). INTERPRETATION: Monofilament suture did not reduce rate of pregnancy loss when compared with a braided suture. Clinicians should use the results of this trial to facilitate discussions around the choice of suture thread to optimise outcomes. FUNDING: National Institute of Health Research Health Technology Assessment Programme.


Subject(s)
Abortion, Spontaneous , Cerclage, Cervical , Premature Birth , Infant, Newborn , Pregnancy , Female , Humans , Cerclage, Cervical/methods , Pregnancy Outcome , Premature Birth/epidemiology , Premature Birth/prevention & control , Abortion, Spontaneous/epidemiology , Abortion, Spontaneous/prevention & control , Sutures
2.
Health Technol Assess ; 26(12): 1-82, 2022 02.
Article in English | MEDLINE | ID: mdl-35195519

ABSTRACT

BACKGROUND: Mother-to-baby transmission of group B Streptococcus (Streptococcus agalactiae) is the main cause of early-onset infection. OBJECTIVES: We investigated if intrapartum antibiotic prophylaxis directed by a rapid intrapartum test reduces maternal and neonatal antibiotic use, compared with usual care (i.e. risk factor-directed antibiotics), among women with risk factors for vertical group B Streptococcus transmission, and examined the accuracy and cost-effectiveness of the rapid test. DESIGN: An unblinded cluster randomised controlled trial with a nested test accuracy study, an economic evaluation and a microbiology substudy. SETTING: UK maternity units were randomised to either a strategy of rapid test or usual care. PARTICIPANTS: Vaginal and rectal swabs were taken from women with risk factors for vertical group B Streptococcus transmission in established term labour. The accuracy of the GeneXpert® Dx IV GBS rapid testing system (Cepheid, Maurens-Scopont, France) was compared with the standard of selective enrichment culture in diagnosing maternal group B Streptococcus colonisation. MAIN OUTCOME MEASURES: Primary outcomes were rates of intrapartum antibiotic prophylaxis administered to prevent early-onset group B Streptococcus infection and accuracy estimates of the rapid test. Secondary outcomes were maternal antibiotics for any indication, neonatal antibiotic exposure, maternal antibiotic duration, neonatal group B Streptococcus colonisation, maternal and neonatal antibiotic resistance, neonatal morbidity and mortality, and cost-effectiveness of the strategies. RESULTS: Twenty-two maternity units were randomised and 20 were recruited. A total of 722 mothers (749 babies) participated in rapid test units and 906 mothers (951 babies) participated in usual-care units. There were no differences in the rates of intrapartum antibiotic prophylaxis for preventing early-onset group B Streptococcus infection in the rapid test units (41%, 297/716) compared with the usual-care units (36%, 328/906) (risk ratio 1.16, 95% confidence interval 0.83 to 1.64). There were no differences between the groups in intrapartum antibiotic administration for any indication (risk ratio 0.99, 95% confidence interval 0.81 to 1.21). Babies born in the rapid test units were 29% less likely to receive antibiotics (risk ratio 0.71, 95% confidence interval 0.54 to 0.95) than those born in usual-care units. The sensitivity and specificity of the rapid test were 86% (95% confidence interval 81% to 91%) and 89% (95% confidence interval 85% to 92%), respectively. In 14% of women (99/710), the rapid test was invalid or the machine failed to provide a result. In the economic analysis, the rapid test was shown to be both less effective and more costly and, therefore, dominated by usual care. Sensitivity analysis indicated potential lower costs for the rapid test strategy when neonatal costs were included. No serious adverse events were reported. CONCLUSIONS: The Group B Streptococcus 2 (GBS2) trial found no evidence that the rapid test reduces the rates of intrapartum antibiotic prophylaxis administered to prevent early-onset group B Streptococcus infection. The rapid test has the potential to reduce neonatal exposure to antibiotics, but economically is dominated by usual care. The accuracy of the test is within acceptable limits. FUTURE WORK: The role of routine testing for prevention of neonatal infection requires evaluation in a randomised controlled trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN74746075. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 12. See the NIHR Journals Library website for further project information.


WHAT IS THE PROBLEM?: Group B Streptococcus is a common bacterium found in the vagina and intestines of approximately one in four women. Group B Streptococcus may be passed to the baby around birth and cause severe infection. In the UK, women are offered antibiotics in labour to protect their baby from group B Streptococcus infection when specific risk factors are present. Most women with risk factors do not carry group B Streptococcus and their babies are unnecessarily exposed to antibiotics. Most women carrying group B Streptococcus do not have risk factors and so will not be offered antibiotics to protect their babies. WHAT DID WE PLAN TO DO?: We planned to find out if, for women with risk factors, a 'rapid test' in labour resulted in fewer women receiving antibiotics compared with 'usual care'. We also wanted to establish if the test correctly identified if mothers were carrying group B Streptococcus, helped reduce infections in babies and represented value for money. WHAT DID WE FIND?: We involved 1627 women (1700 babies) from 20 hospitals randomly allocated to rapid test or usual care. Using the 'rapid test' did not reduce antibiotics provided to mothers (41% in rapid test units and 36% in usual-care units). The test correctly identified 86% of women carrying group B Streptococcus, 89% of those who did not and failed to provide a result in 14% of women. A rapid test policy resulted in 13% fewer babies receiving antibiotics. The rapid test generated no cost savings when only the mothers' care was considered, but there was potential for reduced costs when including the newborns' hospital stay. WHAT DOES THIS MEAN?: The rapid test is accurate; however, using it for women with risk factors for their baby developing group B Streptococcus infection does not reduce antibiotic usage in mothers, although it does in babies. Value for money is uncertain and depends on what costs are included.


Subject(s)
Streptococcal Infections , Streptococcus agalactiae , Anti-Bacterial Agents/therapeutic use , Antibiotic Prophylaxis , Cost-Benefit Analysis , Female , Humans , Infant, Newborn , Mothers , Pregnancy , Streptococcal Infections/diagnosis , Streptococcal Infections/drug therapy , Streptococcal Infections/prevention & control
3.
BMC Med ; 20(1): 9, 2022 01 14.
Article in English | MEDLINE | ID: mdl-35027057

ABSTRACT

BACKGROUND: Mother-to-baby transmission of group B Streptococcus (GBS) is the main cause of early-onset infection. We evaluated whether, in women with clinical risk factors for early neonatal infection, the use of point-of-care rapid intrapartum test to detect maternal GBS colonisation reduces maternal antibiotic exposure compared with usual care, where antibiotics are administered due to those risk factors. We assessed the accuracy of the rapid test in diagnosing maternal GBS colonisation, against the reference standard of selective enrichment culture. METHODS: We undertook a parallel-group cluster randomised trial, with nested test accuracy study and microbiological sub-study. UK maternity units were randomised to a strategy of rapid test (GeneXpert GBS system, Cepheid) or usual care. Within units assigned to rapid testing, vaginal-rectal swabs were taken from women with risk factors for vertical GBS transmission in established term labour. The trial primary outcome was the proportion of women receiving intrapartum antibiotics to prevent neonatal early-onset GBS infection. The accuracy of the rapid test was compared against the standard of selective enrichment culture in diagnosing maternal GBS colonisation. Antibiotic resistance profiles were determined in paired maternal and infant samples. RESULTS: Twenty-two maternity units were randomised and 20 were recruited. A total of 722 mothers (749 babies) participated in rapid test units; 906 mothers (951 babies) were in usual care units. There was no evidence of a difference in the rates of intrapartum antibiotic prophylaxis (relative risk 1.16, 95% CI 0.83 to 1.64) between the rapid test (41%, 297/716) and usual care (36%, 328/906) units. No serious adverse events were reported. The sensitivity and specificity measures of the rapid test were 86% (95% CI 81 to 91%) and 89% (95% CI 85 to 92%), respectively. Babies born to mothers who carried antibiotic-resistant Escherichia coli were more likely to be colonised with antibiotic-resistant strains than those born to mothers with antibiotic-susceptible E. coli. CONCLUSION: The use of intrapartum rapid test to diagnose maternal GBS colonisation did not reduce the rates of antibiotics administered for preventing neonatal early-onset GBS infection than usual care, although with considerable uncertainty. The accuracy of the rapid test is within acceptable limits. TRIAL REGISTRATION: ISRCTN74746075 . Prospectively registered on 16 April 2015.


Subject(s)
Pregnancy Complications, Infectious , Streptococcal Infections , Anti-Bacterial Agents , Escherichia coli , Female , Humans , Infant, Newborn , Pregnancy , Pregnancy Complications, Infectious/diagnosis , Pregnancy Complications, Infectious/drug therapy , Risk Factors , Streptococcal Infections/diagnosis , Streptococcal Infections/drug therapy , Streptococcal Infections/epidemiology , Streptococcus agalactiae
4.
Trials ; 22(1): 664, 2021 Sep 28.
Article in English | MEDLINE | ID: mdl-34583760

ABSTRACT

BACKGROUND: Preterm birth is associated with significant mortality and morbidity for mothers and babies. Women are identified as high risk for preterm birth based on either previous medical/pregnancy history or on ultrasound assessment of the cervix. Women identified as high risk can be offered a cervical cerclage (a purse string stitch) around the cervix (neck of the womb) to reduce the risk of preterm birth. In women who have a cervical cerclage, the procedure can be performed using either a monofilament (single-stranded) or braided (woven) suture material. Both suture materials are routinely used for cervical cerclage and there is uncertainty as to which is superior. METHODS: A multicentre, open, randomised controlled superiority trial of 2050 women presenting at obstetric units, deemed to be at risk of preterm birth and already scheduled to have a cervical cerclage as part of their standard care. Inclusion criteria include singleton pregnancies and an indication for cervical cerclage for either a history of three or more previous mid-trimester losses or premature births (≤ 28 weeks), insertion of cervical sutures in previous pregnancies, a history of mid trimester loss or premature birth with a (current) shortened (≤ 25 mm) cervix, or women whom clinicians deem to be at risk of preterm birth either by history or the results of an ultrasound scan. Exclusion criteria include women who have taken part in C-STICH previously, are aged less than 18 years old at the time of presentation, require a rescue cerclage, and are unwilling or unable to give informed consent and in whom a cerclage will be placed by any route other than vaginally (e.g. via an abdominal route). Following informed consent, women are randomised on a 1:1 basis to either monofilament or braided suture, by minimisation. The primary outcome is pregnancy loss (miscarriage and perinatal mortality, including any stillbirth or neonatal death in the first week of life), and secondary outcomes include the core outcome set for preterm birth trials. DISCUSSION: Optimising established interventions to prevent preterm birth is important in reducing perinatal mortality rates. TRIAL REGISTRATION: ISRCTN 15373349 . Registered before recruitment on 03 December 2014 prior to first recruit.


Subject(s)
Cerclage, Cervical , Premature Birth , Adolescent , Cervix Uteri/diagnostic imaging , Cervix Uteri/surgery , Female , Humans , Infant, Newborn , Outcome Assessment, Health Care , Pregnancy , Premature Birth/etiology , Premature Birth/prevention & control , Sutures
6.
Pediatr Emerg Care ; 37(5): e249-e251, 2021 May 01.
Article in English | MEDLINE | ID: mdl-30045356

ABSTRACT

OBJECTIVE: Sore throat is a common presentation to the children's emergency department (ED), and many patients are likely prescribed antibiotics unnecessarily. We aimed to reduce antibiotic prescribing for sore throat in our UK ED through use of an established scoring system combined with a rapid diagnostic test (RDT) to detect group A streptococcal (GAS) pharyngitis. METHODS: AB single-subject and diagnostic accuracy studies were used to measure both antibiotic prescribing rates over time and the performance of the McIsaac clinical score combined with RDT to screen for and treat GAS pharyngitis. All children between the age of 6 months and 16 years with symptoms of sore throat were eligible for inclusion. The study adhered to SQUIRE guidelines. RESULTS: During 2014 and 2016, antibiotic prescribing rates for 210 children at baseline (median age, 3 years) and 395 children during the intervention (median age, 2 years) were assessed. The baseline prescribing rate was 79%, whereas rates after intervention were 24% and 27%, respectively. The RDT had an acceptable false-negative rate of 7.9%, poor sensitivity of 64.3%, and a negative predictive value of 92.1% when compared with conventional throat culture. A McIsaac score of 3 or more had good sensitivity (92.11%) but very low specificity (12.62%) for predicting GAS infection. CONCLUSIONS: Despite poor RDT sensitivity and the McIsaac score's poor specificity in children, their use in combination decreased antibiotic prescribing rates in a children's ED setting.


Subject(s)
Pharyngitis , Streptococcal Infections , Adolescent , Anti-Bacterial Agents/therapeutic use , Child , Child, Preschool , Diagnostic Tests, Routine , Emergency Service, Hospital , Humans , Infant , Pharyngitis/diagnosis , Pharyngitis/drug therapy , Streptococcal Infections/diagnosis , Streptococcal Infections/drug therapy , Streptococcus pyogenes , United Kingdom
7.
Health Technol Assess ; 24(57): 1-190, 2020 11.
Article in English | MEDLINE | ID: mdl-33174528

ABSTRACT

BACKGROUND: Clinical trials show that antimicrobial-impregnated central venous catheters reduce catheter-related bloodstream infection in adults and children receiving intensive care, but there is insufficient evidence for use in newborn babies. OBJECTIVES: The objectives were (1) to determine clinical effectiveness by conducting a randomised controlled trial comparing antimicrobial-impregnated peripherally inserted central venous catheters with standard peripherally inserted central venous catheters for reducing bloodstream or cerebrospinal fluid infections (referred to as bloodstream infections); (2) to conduct an economic evaluation of the costs, cost-effectiveness and value of conducting additional research; and (3) to conduct a generalisability analysis of trial findings to neonatal care in the NHS. DESIGN: Three separate studies were undertaken, each addressing one of the three objectives. (1) This was a multicentre, open-label, pragmatic randomised controlled trial; (2) an analysis was undertaken of hospital care costs, lifetime cost-effectiveness and value of information from an NHS perspective; and (3) this was a retrospective cohort study of bloodstream infection rates in neonatal units in England. SETTING: The randomised controlled trial was conducted in 18 neonatal intensive care units in England. PARTICIPANTS: Participants were babies who required a peripherally inserted central venous catheter (of 1 French gauge in size). INTERVENTIONS: The interventions were an antimicrobial-impregnated peripherally inserted central venous catheter (coated with rifampicin-miconazole) or a standard peripherally inserted central venous catheter, allocated randomly (1 : 1) using web randomisation. MAIN OUTCOME MEASURE: Study 1 - time to first bloodstream infection, sampled between 24 hours after randomisation and 48 hours after peripherally inserted central venous catheter removal. Study 2 - cost-effectiveness of the antimicrobial-impregnated peripherally inserted central venous catheter compared with the standard peripherally inserted central venous catheters. Study 3 - risk-adjusted bloodstream rates in the trial compared with those in neonatal units in England. For study 3, the data used were as follows: (1) case report forms and linked death registrations; (2) case report forms and linked death registrations linked to administrative health records with 6-month follow-up; and (3) neonatal health records linked to infection surveillance data. RESULTS: Study 1, clinical effectiveness - 861 babies were randomised (antimicrobial-impregnated peripherally inserted central venous catheter, n = 430; standard peripherally inserted central venous catheter, n = 431). Bloodstream infections occurred in 46 babies (10.7%) randomised to antimicrobial-impregnated peripherally inserted central venous catheters and in 44 (10.2%) babies randomised to standard peripherally inserted central venous catheters. No difference in time to bloodstream infection was detected (hazard ratio 1.11, 95% confidence interval 0.73 to 1.67; p = 0.63). Secondary outcomes of rifampicin resistance in positive blood/cerebrospinal fluid cultures, mortality, clinical outcomes at neonatal unit discharge and time to peripherally inserted central venous catheter removal were similar in both groups. Rifampicin resistance in positive peripherally inserted central venous catheter tip cultures was higher in the antimicrobial-impregnated peripherally inserted central venous catheter group (relative risk 3.51, 95% confidence interval 1.16 to 10.57; p = 0.02) than in the standard peripherally inserted central venous catheter group. Adverse events were similar in both groups. Study 2, economic evaluation - the mean cost of babies' hospital care was £83,473. Antimicrobial-impregnated peripherally inserted central venous catheters were not cost-effective. Given the increased price, compared with standard peripherally inserted central venous catheters, the minimum reduction in risk of bloodstream infection for antimicrobial-impregnated peripherally inserted central venous catheters to be cost-effective was 3% and 15% for babies born at 23-27 and 28-32 weeks' gestation, respectively. Study 3, generalisability analysis - risk-adjusted bloodstream infection rates per 1000 peripherally inserted central venous catheter days were similar among babies in the trial and in all neonatal units. Of all bloodstream infections in babies receiving intensive or high-dependency care in neonatal units, 46% occurred during peripherally inserted central venous catheter days. LIMITATIONS: The trial was open label as antimicrobial-impregnated and standard peripherally inserted central venous catheters are different colours. There was insufficient power to determine differences in rifampicin resistance. CONCLUSIONS: No evidence of benefit or harm was found of peripherally inserted central venous catheters impregnated with rifampicin-miconazole during neonatal care. Interventions with small effects on bloodstream infections could be cost-effective over a child's life course. Findings were generalisable to neonatal units in England. Future research should focus on other types of antimicrobial impregnation of peripherally inserted central venous catheters and alternative approaches for preventing bloodstream infections in neonatal care. TRIAL REGISTRATION: Current Controlled Trials ISRCTN81931394. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 57. See the NIHR Journals Library website for further project information.


Babies who are born too early or who are very sick require intensive care after birth and during early life. Most will have a long, narrow, plastic tube, called a catheter, inserted into a vein. The catheter is used to give babies fluids containing medicines and nutrition to keep them well and help them grow. The catheter can remain in place for several days or weeks. But the presence of plastic tubing in the vein increases the risk of infection. This study aimed to find out whether or not catheters coated with antimicrobial medicines, called rifampicin and miconazole, could reduce the risk of infection. These medicines act by stopping germs from growing on the catheter, but do not harm the baby or interfere with other treatments. A randomised controlled trial was carried out in 18 neonatal units in England. Whenever a baby needed a catheter, their parents were asked for consent to participate in the trial. The baby was then randomised, similar to tossing a coin, to receive either the antimicrobial catheter or a standard one. A total of 861 babies participated. We followed up all babies in the same way until after the catheter was removed to compare how often babies in each group had an infection. It was found that antimicrobial catheters were no better or worse at preventing infection than standard catheters. Antimicrobial catheters cost more and we found no evidence of benefit; these results suggest that their use in neonatal intensive care is not justified. It was calculated that further research on ways to reduce infection may be good value for money, depending on the costs of this research. The babies who took part in this study were typical of babies in England receiving catheters, meaning that the results can be applied across the NHS. Future research should focus on catheters that contain other types of antimicrobials and alternative ways of preventing infection.


Subject(s)
Anti-Infective Agents/administration & dosage , Catheter-Related Infections/prevention & control , Central Venous Catheters , Intensive Care Units, Neonatal , Sepsis/prevention & control , Anti-Infective Agents/economics , Catheter-Related Infections/economics , Cost-Benefit Analysis , Humans , Infant, Newborn , Miconazole/administration & dosage , Retrospective Studies , Rifampin/administration & dosage , Risk Factors , Technology Assessment, Biomedical , United Kingdom
9.
Post Reprod Health ; 26(2): 91-100, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32252595

ABSTRACT

OBJECTIVE: The aim of this study was to repeat a previous audit, performed from 2009 to 2013, for the cohort of 2018 to determine how the resistance rates in urinary pathogens in women over 18 years of age have changed. A secondary aim of the study was to use resistance data from a different UK hospital in the same year to compare differences in resistance rates across different geographic locations. STUDY DESIGN: This was a retrospective study of all positive urine cultures grown from female patients attending two different hospitals in the year 2018. Resistance patterns were analysed. RESULTS: The resistance rate to co-amoxiclav continues to increase with amoxicillin retaining high resistance patterns. There are some significant differences in resistance patterns between the different locations. CONCLUSION: Antimicrobial resistance is a significant problem in the UK particularly in antibiotics used to treat UTI. These patterns can vary across different geographical locations and over time; therefore, up-to-date knowledge of local anti-biotic resistance is essential when making an appropriate prescription choice.


Subject(s)
Drug Resistance, Bacterial , Gram-Negative Bacterial Infections/microbiology , Gram-Positive Bacterial Infections/microbiology , Urinary Tract Infections/microbiology , Adult , Aged , Aged, 80 and over , Anti-Bacterial Agents/pharmacology , Anti-Bacterial Agents/therapeutic use , Antimicrobial Stewardship , Female , Gram-Negative Bacterial Infections/drug therapy , Gram-Positive Bacterial Infections/drug therapy , Humans , Medical Audit , Middle Aged , Retrospective Studies , United Kingdom , Urinary Tract Infections/drug therapy
10.
J Hosp Infect ; 2020 Mar 11.
Article in English | MEDLINE | ID: mdl-32171754
11.
PLoS One ; 14(12): e0226040, 2019.
Article in English | MEDLINE | ID: mdl-31830076

ABSTRACT

OBJECTIVE: To evaluate variation in trends in bloodstream infection (BSI) rates in neonatal units (NNUs) in England according to the data sources and linkage methods used. METHODS: We used deterministic and probabilistic methods to link clinical records from 112 NNUs in the National Neonatal Research Database (NNRD) to national laboratory infection surveillance data from Public Health England. We calculated the proportion of babies in NNRD (aged <1 year and admitted between 2010-2017) with a BSI caused by clearly pathogenic organisms between two days after admission and two days after discharge. We used Poisson regression to determine trends in the proportion of babies with BSI based on i) deterministic and probabilistic linkage of NNRD and surveillance data (primary measure), ii) deterministic linkage of NNRD-surveillance data, iii) NNRD records alone, and iv) linked NNRD-surveillance data augmented with clinical records of laboratory-confirmed BSI in NNRD. RESULTS: Using deterministic and probabilistic linkage, 5,629 of 349,740 babies admitted to a NNU in NNRD linked with 6,660 BSI episodes accounting for 38% of 17,388 BSI records aged <1 year in surveillance data. The proportion of babies with BSI due to clearly pathogenic organisms during their NNU admission was 1.0% using deterministic plus probabilistic linkage (primary measure), compared to 1.0% using deterministic linkage alone, 0.6% using NNRD records alone, and 1.2% using linkage augmented with clinical records of BSI in NNRD. Equivalent proportions for babies born before 32 weeks of gestation were 5.0%, 4.8%, 2.9% and 5.9%. The proportion of babies who linked to a BSI decreased by 7.5% each year (95% confidence interval [CI]: -14.3%, -0.1%) using deterministic and probabilistic linkage but was stable using clinical records of BSI or deterministic linkage alone. CONCLUSION: Linkage that combines BSI records from national laboratory surveillance and clinical NNU data sources, and use of probabilistic methods, substantially improved ascertainment of BSI and estimates of BSI trends over time, compared with single data sources.


Subject(s)
Bacteremia/epidemiology , Electronic Health Records/statistics & numerical data , Infant, Newborn, Diseases/epidemiology , Intensive Care Units, Pediatric/statistics & numerical data , Population Surveillance/methods , Bacteremia/congenital , Data Accuracy , Databases, Factual , England/epidemiology , Female , Gestational Age , Humans , Infant, Newborn , Infant, Newborn, Diseases/blood , Male , Medical Record Linkage/methods
12.
Lancet Child Adolesc Health ; 3(6): 381-390, 2019 06.
Article in English | MEDLINE | ID: mdl-31040096

ABSTRACT

BACKGROUND: Bloodstream infection is associated with high mortality and serious morbidity in preterm babies. Evidence from clinical trials shows that antimicrobial-impregnated central venous catheters (CVCs) reduce catheter-related bloodstream infection in adults and children receiving intensive care, but there is a paucity of similar evidence for babies receiving neonatal intensive care. METHODS: This open-label, parallel-group, pragmatic, randomised controlled trial was done in 18 neonatal intensive care units in England. Newborn babies who needed a peripherally inserted CVC (PICC) were allocated randomly (1:1) to receive either a PICC impregnated with miconazole and rifampicin or a standard (non-antimicrobial-impregnated) PICC. Random allocation was done with a web-based program, which was centrally controlled to ensure allocation concealment. Randomisation sequences were computer-generated in random blocks of two and four, and stratified by site. Masking of clinicians to PICC allocation was impractical because rifampicin caused brown staining of the antimicrobial-impregnated PICC. However, participant inclusion in analyses and occurrence of outcome events were determined following an analysis plan that was specified before individuals saw the unblinded data. The primary outcome was the time from random allocation to first microbiologically confirmed bloodstream or cerebrospinal fluid (CSF) infection between 24 h after randomisation and 48 h after PICC removal or death. We analysed outcome data according to the intention-to-treat principle. We excluded babies for whom a PICC was not inserted from safety analyses, as these analyses were done with groups defined by the PICC used. This trial is registered with ISRCTN, number 81931394. FINDINGS: Between Aug 12, 2015, and Jan 11, 2017, we randomly assigned 861 babies (754 [88%] born before 32 weeks of gestation) to receive an antimicrobial-impregnated PICC (430 babies) or standard PICC (431 babies). The median time to PICC removal was 8·20 days (IQR 4·77-12·13) in the antimicrobial-impregnated PICC group versus 7·86 days (5·00-12·53) days in the standard PICC group (hazard ratio [HR] 1·03, 95% CI 0·89-1·18, p=0·73), with 46 (11%) of 430 babies versus 44 (10%) of 431 babies having a microbiologically confirmed bloodstream or CSF infection. The time from random allocation to first bloodstream or CSF infection was similar between the two groups (HR 1·11, 95% CI 0·73-1·67, p=0·63). Secondary outcomes relating to infection, rifampicin resistance in positive blood or CSF cultures, mortality, clinical outcomes at neonatal unit discharge, and time to PICC removal were similar between the two groups, although rifampicin resistance in positive cultures of PICC tips was higher in the antimicrobial-impregnated PICC group (relative risk 3·51, 95% CI 1·16-10·57, p=0·018). 60 adverse events were reported from 49 (13%) patients in the antimicrobial-impregnated PICC group and 50 events from 45 (10%) babies in the standard PICC group. INTERPRETATION: We found no evidence of benefit or harm associated with miconazole and rifampicin-impregnated PICCs compared with standard PICCs for newborn babies. Future research should focus on other types of antimicrobial impregnation of PICCs and alternative approaches for preventing infection. FUNDING: UK National Institute for Health Research Health Technology Assessment programme.


Subject(s)
Anti-Infective Agents/administration & dosage , Catheter-Related Infections/prevention & control , Catheterization, Central Venous/methods , Central Venous Catheters/statistics & numerical data , Intensive Care Units, Neonatal , Neonatal Sepsis/prevention & control , England , Female , Humans , Infant, Newborn , Male , Minocycline/administration & dosage , Neonatal Sepsis/drug therapy , Rifampin/administration & dosage , Treatment Outcome
13.
J Infect ; 74(3): 236-242, 2017 03.
Article in English | MEDLINE | ID: mdl-27867063

ABSTRACT

OBJECTIVE: To define the clinical features and outcomes of neonatal listeriosis, and identify the maternal risk factors to seek scope for improvement. METHODS: Neonatal listeriosis was identified prospectively from a United Kingdom neonatal infection surveillance network (neonIN) between 2004 and 2014. The participating neonatal units completed a study-specific proforma. RESULTS: The incidence of neonatal listeriosis was 3.4 per 100,000 live births. Of the 21 cases identified, 19 were confirmed with a median gestational age of 33 weeks and a median birth weight of 1960 g. The majority had clinical features (95%, 18/19), presented within the first 24 h (95%, 18/19), and received penicillin empirically (94%, 18/19). The neonatal case-fatality rate was 21% (24% if probable cases were included). A proportion of mothers were investigated (60%, 12/18) and diagnosed with listeriosis (58%, 7/12); 32% (6/19) were treated with antibiotics but only 33% (6/12) included penicillin. DISCUSSION: Despite its rarity and the prompt and appropriate use of antibiotics neonatal listeriosis has a high case-fatality rate. There is room for improvement in the adherence to the empiric antibiotic choice for puerperal sepsis, according to the national guidelines as this, would target listeriosis. Strategies should be in place to prevent pregnancy-associated listeriosis in higher risk population.


Subject(s)
Listeriosis/epidemiology , Pregnancy Complications, Infectious/epidemiology , Adult , Anti-Bacterial Agents/therapeutic use , Female , Humans , Incidence , Infant, Newborn , Listeriosis/drug therapy , Listeriosis/microbiology , Male , Pregnancy , Pregnancy Complications, Infectious/ethnology , Pregnancy Complications, Infectious/microbiology , Prospective Studies , Risk Factors , Sepsis/diagnosis , Sepsis/drug therapy , Sepsis/epidemiology , Sepsis/microbiology , United Kingdom/epidemiology , Young Adult
15.
Post Reprod Health ; 21(4): 151-7, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26545976

ABSTRACT

OBJECTIVE: In 2010, our hospital, in line with National guidance, changed advice on antibiotic prescribing for UTI to reduce use of cephalosporins in favour of penicillins. We hypothesized that this change in policy would have no impact on the pattern of antibiotic resistance of the organisms causing UTI. STUDY DESIGN: Audit review of all urine samples sent to BWH from 2009 to 2013 and positive cultures showing Enterobacteriaceae were then tested for antibiotic susceptibility. RESULTS: There has been an increase in the resistance of both Co-amoxiclav and Ciprofloxacin since 2009. Co-amoxiclav and trimethoprim now have similar resistance rates. Ciprofloxacin resistance has risen fairly quickly in the last four years from 1% to 8%. Resistance to nitrofurantoin has remained low. Gentamicin resistance remained stable and very low, second best to meroponem. IMPACT: The results have been fed back to commissioners and internally and are being used as part of the guideline updating process. CONCLUSIONS: Hospital protocols for treating infections should be reviewed and updated based on accurate local data. These data should be used for formulating regional specific protocols. Our results suggest that meroponem and ciprofloxacin should be reserved for microbiologically proven resistance to other antibiotics.


Subject(s)
Anti-Bacterial Agents/pharmacology , Drug Resistance, Bacterial , Enterobacteriaceae Infections/drug therapy , Enterobacteriaceae/drug effects , Urinary Tract Infections/drug therapy , Amoxicillin-Potassium Clavulanate Combination/pharmacology , Ciprofloxacin/pharmacology , Clinical Audit , England , Female , Gentamicins/pharmacology , Health Policy , Humans , Meropenem , Microbial Sensitivity Tests , Nitrofurantoin/pharmacology , Practice Guidelines as Topic , Thienamycins/pharmacology , Trimethoprim/pharmacology , Urinary Tract Infections/microbiology
16.
BMJ Case Rep ; 20142014 Feb 20.
Article in English | MEDLINE | ID: mdl-24557475

ABSTRACT

We present a case of a 24-year-old man who suffered acute shoulder pain and subsequent inability to move his arm while lifting weights in the bench-press position. He attended A&E where he was examined and X-rays were performed. He was diagnosed with presumed pectoralis major tendon rupture and was discharged to fracture clinic the following day with analgesia. On review in clinic he was found to have a posterior shoulder dislocation and was taken to theatre for relocation under anaesthesia. This case report examines the mechanism, investigations and management of posterior shoulder dislocation.


Subject(s)
Diagnostic Errors , Shoulder Dislocation/diagnosis , Shoulder Pain/etiology , Weight Lifting/injuries , Humans , Male , Shoulder Dislocation/complications , Shoulder Dislocation/therapy , Young Adult
18.
J Med Microbiol ; 62(Pt 10): 1535-1539, 2013 Oct.
Article in English | MEDLINE | ID: mdl-23831766

ABSTRACT

A universal stool extraction method for recovery of nucleic acids (NAs) from gastrointestinal pathogens was developed to support rapid diagnostics for the London 2012 Olympics. The method involved mechanical disruption (bead beating) of the stools, followed by automated extraction and detection using real-time PCR. This method had been used extensively in the Second Infectious Intestinal Disease Study (IID2) for the isolation of NA from bacteria and parasites (and was effective for the robust recovery of Cryptosporidium spp.) but had not been used for enteric viruses. To ensure this method was universally suitable, panels of samples known to contain target bacteria, viruses or parasites were processed in triplicate using the pre-treatment method routinely used for each target and the new extraction method (bead beating). The extracts were tested using real-time PCR and the cycle threshold values were compared. The results from this study showed that bead beating improved yields for the bacterial and parasitic targets and was suitable for the viral targets. The implementation of this universal method should confer cost- and time-saving benefits and streamline the processes required for the characterization of an array of pathogens from faecal samples.


Subject(s)
DNA/isolation & purification , Feces/microbiology , Feces/parasitology , Gastroenteritis/etiology , Molecular Diagnostic Techniques/methods , Real-Time Polymerase Chain Reaction/methods , Specimen Handling/methods , Bacterial Infections/diagnosis , DNA/genetics , Humans , Intestinal Diseases, Parasitic/diagnosis , London , Molecular Diagnostic Techniques/economics , Real-Time Polymerase Chain Reaction/economics , Specimen Handling/economics , Time Factors
19.
Intensive Care Med ; 39(6): 1080-7, 2013 Jun.
Article in English | MEDLINE | ID: mdl-23404472

ABSTRACT

PURPOSE: National monitoring of variation in the quality of infection control in paediatric intensive care units (PICUs) requires comparisons of risk-adjusted rates. To inform the development of a national monitoring system, we evaluated the effects of risk-adjustment and outcome definition on comparisons of blood-stream infection (BSI) rates in PICU, using linkage of risk-factor data captured by national audit (PICANet) with laboratory records of BSI. METHODS: Admission data for two children's hospitals 2003-2010 were extracted from PICANet and linked using multiple identifiers with laboratory BSI records. We calculated trends of PICU-acquired BSI, defined as BSI occurring between at least 2 days after admission until up to 2 days following discharge. In one PICU, we compared rates of all PICU-acquired BSI with clinically significant PICU-acquired BSI submitted to the national surveillance system. RESULTS: Of 20,924 admissions, 1,428 (6.8 %) were linked to 1,761 PICU-acquired BSI episodes. The crude incidence rate-ratio for PICU-acquired BSI between PICUs was 1.15 [95 % confidence interval (CI) 1.05-1.26] but increased to 1.26 (1.14-1.39) after risk-adjustment. Rates of PICU-acquired BSI were 13.44 (95 % CI 12.60-14.28) per 1,000 bed-days at PICU 1 and 18.05 (95 % CI 16.80-19.32) at PICU 2. Of PICU-acquired BSI at PICU 2, 41 % was classified as clinically significant. Rates of PICU-acquired BSI decreased by 10 % per year between 2003 and 2010 for skin organisms and 8 % for non-skin organisms. CONCLUSIONS: Risk-adjustment and standardisation of outcome measures are essential for fair comparisons of BSI rates between PICUs. Linkage of risk-factor data and BSI surveillance is feasible and could allow national risk-adjusted monitoring.


Subject(s)
Bacteremia/prevention & control , Cross Infection/prevention & control , Infection Control/methods , Intensive Care Units, Pediatric , Quality Assurance, Health Care , Risk Adjustment/methods , Bacteremia/epidemiology , Child , Child, Preschool , Cross Infection/epidemiology , Female , Humans , Infant , Infant, Newborn , Male , Population Surveillance , Risk Factors , United Kingdom/epidemiology
20.
Medicine (Abingdon) ; 41(12): 700-704, 2013 Dec.
Article in English | MEDLINE | ID: mdl-32288575

ABSTRACT

This article reviews the virology, immunology and epidemiology of the most common viral causes of acute gastroenteritis (rotaviruses, human caliciviruses, astroviruses and enteric adenoviruses). The clinical symptoms span from mild diarrhoea to life-threatening dehydration, and rotavirus disease is a major cause of childhood mortality, mainly in developing countries. The diagnosis, treatment and preventive measures are reviewed. Uncommon viral causes of acute gastroenteritis and viruses causing gastroenteritis in immunodeficient patients are mentioned. The clinically most important development in this field over the past 3 years has been the wide application of the new live attenuated rotavirus vaccines in universal mass vaccination programmes in many countries.

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