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1.
Crit Care Clin ; 35(4): 697-710, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31445614

RESUMO

Outbreaks of Ebola virus disease and high-risk transmissible infections are increasing and pose threats to health care workers and global health systems. Previous outbreaks offer lessons for health system preparedness and response, including establishment of hospital-based high-risk pathogen treatment units. Their creation demands early preparation and interprofessional coordination; infection prevention and control; case management training; prepositioning of supplies; conversion of existing structures to treatment units; and strengthening communication and research platforms. Hospital-based Ebola and high-risk pathogen treatment units may improve case detection, interrupt transmission, and improve staff safety and patient care.

2.
JAMA Netw Open ; 2(8): e199875, 2019 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-31441937

RESUMO

Importance: Over the past 2 decades, there has been a trend toward increasing maternal age in many high-income countries. Maternal age may lead to greater attendant morbidity and mortality for Canadian mothers. Objective: To investigate the association of maternal age, adjusting for patient-level and hospital-level factors, with severe maternal morbidity (SMM) and maternal death in Canada. Design, Setting, and Participants: A nationwide population-based cohort study of all antepartum, peripartum, and postpartum women and adolescents seen at Canadian acute care hospitals from April 1, 2004, to March 31, 2015. All analyses were completed on September 13, 2018. Exposures: Maternal age at the index delivery. Main Outcomes and Measures: Severe maternal morbidity and maternal death during pregnancy and within 6 weeks after termination of pregnancy. Results: During the study period, there were 3 162 303 new pregnancies (mean [SD] maternal age, 29.5 [5.6] years) and 3 533 259 related hospital admissions. There were 54 219 episodes of SMM (17.7 cases per 1000 deliveries) in the entire study period, with a 9.8% relative increase from 2004-2005 to 2014-2015, in addition to an increasing proportion of pregnancies to older mothers. Independent patient-level factors associated with SMM included increasing Maternal Comorbidity Index; maternal age 19 years or younger and 30 years or older, with the greatest risk experienced by women 45 years or older (odds ratio [OR], 2.69; 95% CI, 2.34-3.06 compared with maternal age 20-24 years); and lowest income quintile (OR, 1.19; 95% CI, 1.14-1.22 compared with highest income quintile). Hospital-level factors associated with SMM included specific provinces. Independent patient-level factors associated with maternal mortality included increasing Maternal Comorbidity Index, age 40 to 44 years (OR, 3.39; 95% CI, 1.68-6.82 compared with age 20-24 years), age 45 years or older (OR, 4.39; 95% CI, 1.01-19.10 compared with age 20-24 years), and lowest income quintile (OR, 4.14; 95% CI, 2.03-8.50 compared with highest income quintile). Hospital-level factors associated with maternal mortality included lowest hospital pregnancy volume. Conclusions and Relevance: In Canada, maternal age and SMM have increased over the past decade. Results of this study suggest that province of residence, maternal comorbidity, residence income quintile, and extremes of maternal age, especially those 45 years or older, were associated with SMM and mortality. These findings are relevant to prospective parents, their health care team, and public health planning.

3.
JAMA Netw Open ; 2(7): e197650, 2019 Jul 03.
Artigo em Inglês | MEDLINE | ID: mdl-31339549

RESUMO

Importance: The idea that physicians as patients choose less-aggressive care at the end of life for themselves is an often-cited rationale to advocate for less technology-laden end-of-life care. Objective: To assess end-of-life care received by physicians compared with nonphysicians in a system with universal health care. Design, Setting, and Participants: In this population-level decedent cohort study of data from April 1, 2004, through March 31, 2015 (fiscal years 2004-2014), in Ontario, Canada, 2507 physicians were matched approximately 1:3 to 7513 nonphysicians (ie, individuals who never were registered as a physician with the College of Physicians and Surgeons of Ontario) according to age, sex, income quintile, and location of residence. Main Outcomes and Measures: The primary outcome was location of death. Other outcomes included measures of health care use in the last 6 months of life. Differences were assessed using Poisson regression with robust error variances, adjusting for the Charlson Comorbidity Index. Results: In total, 2516 physicians and 954 836 nonphysicians died between April 1, 2004, and March 31, 2015, in Ontario; 2247 physicians (89.3%) and 474 182 nonphysicians (49.7%) were men. The median (interquartile range) age at death was 82 (74-87) years for the physicians and 80 (68-87) years for the nonphysicians. After matching, data for 2507 physicians and 7513 nonphysicians were analyzed. For physicians, the risk of death at home was no different from that for nonphysicians (42.8% vs 39.0%; adjusted relative risk [aRR], 1.04; 95% CI, 0.99-1.09), but the risk of death in an intensive care unit was increased (11.9% vs 10.0%; aRR, 1.22; 95% CI, 1.08-1.39). In the prior 6 months, physicians had a decreased risk of an emergency department visit (73.0% vs 78.4%; aRR, 0.96; 95% CI, 0.94-0.98) but increased risks of an intensive care unit admission (20.8% vs 19.1%; aRR, 1.14; 95% CI, 1.05-1.24) and of receipt of palliative care services (52.9% vs 47.4%; aRR, 1.18; 95% CI, 1.13-1.23). Among a subgroup of 457 physicians and 1347 nonphysicians with cancer, the risk of death at home or intensive care unit was increased (37.6% vs 28.6%; aRR, 1.30; 95% CI, 1.13-1.50), as was the risk of receiving chemotherapy in the last 6 months of life. Conclusions and Relevance: There was no difference overall for physicians compared with nonphysicians in terms of the likelihood of dying at home; physicians were more likely to die in an intensive care unit and to receive chemotherapy, but also to receive palliative care services. These findings suggest that physicians do not consistently opt for less-aggressive care but instead receive end-of-life care that includes both intensive and palliative care. These findings inform a more nuanced perspective of what physicians may perceive to be optimal care at the end of life.

4.
Ann Surg ; 269(6): 1192-1199, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31082920

RESUMO

OBJECTIVE: To estimate long-term mortality following major burn injury compared with matched controls. SUMMARY BACKGROUND DATA: The effect of sustaining a major burn injury on long-term life expectancy is poorly understood. METHODS: Using health administrative data, all adults who survived to discharge after major burn injury between 2003 and 2013 were matched to between 1 and 5 uninjured controls on age, sex, and the extent of both physical and psychological comorbidity. To account for socioeconomic factors such as residential instability and material deprivation, we also matched on marginalization index. The primary outcome was 5-year all-cause mortality, and all patients were followed until death or March 31, 2014. Cumulative mortality estimates were estimated using the Kaplan-Meier method. Cox proportional hazards modeling was used to estimate the association of burn injury with mortality. RESULTS: In total, 1965 burn survivors of mean age 44 (standard deviation 17) years with median total body surface area burn of 15% [interquartile range (IQR) 5-15] were matched to 8671 controls and followed for a median 5 (IQR 2.5-8) years. Five-year mortality was significantly greater among burn survivors (11 vs 4%, P < 0.001). The hazard ratio was greatest during the first year (4.15, 95% CI 3.17-5.42), and declined each year thereafter, reaching 1.65 (95% CI 1.02-2.67) in the fifth year after discharge. Burn survivors had increased mortality related to trauma (mortality rate ratio, MRR 9.8, 95% CI 5-19) and mental illness (MRR 9.1, 95% CI 4-23). CONCLUSIONS: Burn survivors have a significantly higher rate of long-term mortality than matched controls, particularly related to trauma and mental illness. Burn follow-up should be focused on injury prevention, mental healthcare, and detection and treatment of new disease.

5.
BMC Infect Dis ; 19(1): 376, 2019 May 02.
Artigo em Inglês | MEDLINE | ID: mdl-31046707

RESUMO

BACKGROUND: Management of Ebola virus disease (EVD) has historically focused on infection prevention, case detection and supportive care. Several specific anti-Ebola therapies have been investigated, including during the 2014-2016 West African outbreak. Our objective was to conduct a systematic review of the effect of anti-Ebola virus therapies on clinical outcomes to guide their potential use and future evaluation. METHODS: We searched PubMed, EMBASE, Global Health, Cochrane Library, African Index Medicus, WHOLIS (inception-9 April 2018), and trial registries for observational studies or clinical trials, in any language, that enrolled patients with confirmed EVD who received therapy targeting Ebola virus and reported on mortality, symptom duration, or adverse effects. RESULTS: From 11,257 citations and registered trials, we reviewed 55 full-text citations, of which 35 met eligibility criteria (1 randomized clinical trial (RCT), 8 non-randomized comparative studies, 9 case series and 17 case reports) and collectively examined 21 anti-Ebola virus agents. The 31 studies performed during the West African outbreak reported on 4.8% (1377/28616) of all patients with Ebola. The only RCT enrolled 72 patients (0.25% of all patients with Ebola) and compared the monoclonal antibody ZMapp vs. standard care (mortality, 22% vs. 37%; 95% confidence interval for risk difference, - 36 to 7%). Studies of convalescent plasma, interferon-ß-1a, favipiravir, brincidofovir, artesunate-amodiaquine and TKM-130803 were associated with at least moderate risk of bias. CONCLUSIONS: Research evaluating anti-Ebola virus agents has reached very few patients with EVD, and inferences are limited by non-randomized study designs. ZMapp has the most promising treatment signal.


Assuntos
Antivirais/uso terapêutico , Doença pelo Vírus Ebola/tratamento farmacológico , Amidas/uso terapêutico , Amodiaquina/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Artemisininas/uso terapêutico , Bases de Dados Factuais , Combinação de Medicamentos , Ebolavirus/isolamento & purificação , Doença pelo Vírus Ebola/epidemiologia , Doença pelo Vírus Ebola/virologia , Humanos , Pirazinas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto
7.
Influenza Other Respir Viruses ; 13(4): 382-390, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30884185

RESUMO

BACKGROUND: Noninvasive ventilation (NIV) has been used in patients with the Middle East respiratory syndrome (MERS) with acute hypoxemic respiratory failure, but the effectiveness of this approach has not been studied. METHODS: Patients with MERS from 14 Saudi Arabian centers were included in this analysis. Patients who were initially managed with NIV were compared to patients who were managed only with invasive mechanical ventilation (invasive MV). RESULTS: Of 302 MERS critically ill patients, NIV was used initially in 105 (35%) patients, whereas 197 (65%) patients were only managed with invasive MV. Patients who were managed with NIV initially had lower baseline SOFA score and less extensive infiltrates on chest radiograph compared with patients managed with invasive MV. The vast majority (92.4%) of patients who were managed initially with NIV required intubation and invasive mechanical ventilation, and were more likely to require inhaled nitric oxide compared to those who were managed initially with invasive MV. ICU and hospital length of stay were similar between NIV patients and invasive MV patients. The use of NIV was not independently associated with 90-day mortality (propensity score-adjusted odds ratio 0.61, 95% CI [0.23, 1.60] P = 0.27). CONCLUSIONS: In patients with MERS and acute hypoxemic respiratory failure, NIV failure was very high. The use of NIV was not associated with improved outcomes.

10.
Int J Infect Dis ; 81: 184-190, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30690213

RESUMO

OBJECTIVES: Macrolides have been reported to be associated with improved outcomes in patients with viral pneumonia related to influenza and other viruses, possibly because of their immune-modulatory effects. Macrolides have frequently been used in patients with Middle East Respiratory Syndrome (MERS). This study investigated the association of macrolides with 90-day mortality and MERS coronavirus (CoV) RNA clearance in critically ill patients with MERS. METHODS: This retrospective analysis of a multicenter cohort database included 14 tertiary-care hospitals in five cities in Saudi Arabia. Multivariate logistic-regression analysis was used to determine the association of macrolide therapy with 90-day mortality, and the Cox-proportional hazard model to determine the association of macrolide therapy with MERS-CoV RNA clearance. RESULTS: Of 349 critically ill MERS patients, 136 (39%) received macrolide therapy. Azithromycin was most commonly used (97/136; 71.3%). Macrolide therapy was commonly started before the patient arrived in the intensive care unit (ICU) (51/136; 37.5%), or on day1 in ICU (53/136; 39%). On admission to ICU, the baseline characteristics of patients who received and did not receive macrolides were similar, including demographic data and sequential organ failure assessment score. However, patients who received macrolides were more likely to be admitted with community-acquired MERS (P=0.02). Macrolide therapy was not independently associated with a significant difference in 90-day mortality (adjusted odds ratio [OR]: 0.84; 95% confidence interval [CI] :0.47-1.51; P=0.56) or MERS-CoV RNA clearance (adjusted HR: 0.88; 95% CI:0.47-1.64; P=0.68). CONCLUSIONS: These findings indicate that macrolide therapy is not associated with a reduction in 90-day mortality or improvement in MERS-CoV RNA clearance.


Assuntos
Antibacterianos/administração & dosagem , Infecções por Coronavirus/tratamento farmacológico , Macrolídeos/administração & dosagem , Coronavírus da Síndrome Respiratória do Oriente Médio/efeitos dos fármacos , Adulto , Idoso , Infecções por Coronavirus/mortalidade , Infecções por Coronavirus/virologia , Estado Terminal/terapia , Feminino , Humanos , Unidades de Terapia Intensiva/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Coronavírus da Síndrome Respiratória do Oriente Médio/genética , Coronavírus da Síndrome Respiratória do Oriente Médio/isolamento & purificação , Estudos Retrospectivos , Arábia Saudita
11.
Ann Am Thorac Soc ; 16(4): 463-470, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30620621

RESUMO

RATIONALE: Mechanically ventilated patients require complex care and are at high risk for rehospitalization, but different systems of care may result in different hospital discharge practices and rates of rehospitalization. OBJECTIVES: To compare lengths of hospitalization, discharge patterns, and rehospitalization rates in New York in the United States and Ontario in Canada. METHODS: We conducted a retrospective cohort study of mechanically ventilated patients who survived an acute care hospitalization in New York or Ontario from 2010 to 2012, using linkable administrative healthcare data. RESULTS: The primary outcome was the cumulative incidence of first rehospitalization within 30 days of discharge, accounting for the competing risk of death. Of 71,063 mechanically ventilated patients in New York, and 41,875 in Ontario who survived to hospital discharge, median length of initial hospital stay was similar in New York and Ontario (15 d, interquartile range = 8-28 vs. 16 d [9-30]), but was systematically shorter in New York when stratified by patient subgroups of different illness severity. Fewer patients in New York were discharged directly home (53.6% vs. 71.4%). Of patients in New York, 15,527 (cumulative incidence 21.9%) had a first rehospitalization within 30 days versus 5,580 (cumulative incidence 13.3%) in Ontario (P < 0.001). Incidence of rehospitalization was higher in New York across all subgroups assessed, with the greatest differences among patients with a tracheostomy (29.8% vs. 13.3%, P < 0.001), those who received dialysis during the hospitalization (31.9% vs. 17.4%, P < 0.001), and for patients not discharged directly home (27.6% vs. 13.3%, P < 0.001). CONCLUSIONS: Care patterns for mechanically ventilated patients in New York and Ontario are very different; mechanically ventilated patients who survive to hospital discharge in New York have shorter hospital stays, with higher rehospitalization rates within 30 days compared with Ontario.

12.
Anesth Analg ; 2019 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-30633052

RESUMO

The number of elderly patients with dementia receiving invasive mechanical ventilation is increasing over time in the United States, while the balance of potential benefits and harms of intensive care interventions in this population is unclear. In this report, we describe trends in use of invasive mechanical ventilation in elderly individuals with and without dementia in Ontario, Canada, and provide projections of the use of invasive mechanical ventilation through 2025. We show that rates of invasive mechanical ventilation for elderly patients with dementia are increasing faster than for the rest of the elderly (nondementia) population.

13.
Clin Infect Dis ; 69(7): 1099-1100, 2019 Sep 13.
Artigo em Inglês | MEDLINE | ID: mdl-30535118
14.
PLoS One ; 13(12): e0208563, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30513118

RESUMO

PURPOSE: Pregnancy-related critical illness leads to death for 3-14% of affected women. Although identifying patients at risk could facilitate preventive strategies, guide therapy, and help in clinical research, no prior systematic review of this literature exploring the validity of risk prediction models for maternal mortality exists. Therefore, we have systematically reviewed and meta-analyzed risk prediction models for maternal mortality. METHODS: Search strategy: MEDLINE, EMBASE and Scopus, from inception to May 2017. Selection criteria: Trials or observational studies evaluating risk prediction models for maternal mortality. Data collection and analysis: Two reviewers independently assessed studies for eligibility and methodological quality, and extracted data on prediction performance. RESULTS: Thirty-eight studies that evaluated 12 different mortality prediction models were included. Mortality varied across the studies, with an average rate 10.4%, ranging from 0 to 41.7%. The Collaborative Integrated Pregnancy High-dependency Estimate of Risk (CIPHER) model and the Maternal Severity Index had the best performance, were developed and validated from studies of obstetric population with a low risk of bias. The CIPHER applies to critically ill obstetric patients (discrimination: area under the receiver operating characteristic curve (AUC) 0.823 (0.811-0.835), calibration: graphic plot [intercept-0.09, slope 0.92]). The Maternal Severity Index applies to hospitalized obstetric patients (discrimination: AUC 0.826 [0.802-0.851], calibration: standardized mortality ratio 1.02 [0.86-1.20]). CONCLUSIONS: Despite the high heterogeneity of the study populations and the limited number of studies validating the finally eligible prediction models, the CIPHER and the Maternal Severity Index are recommended for use among critically ill and hospitalized pregnant and postpartum women for risk adjustment in clinical research and quality improvement studies. Neither index has sufficient discrimination to be applicable for clinical decision making at the individual patient level.

15.
Artigo em Inglês | MEDLINE | ID: mdl-30385209

RESUMO

OBJECTIVE: Pregnancy-associated morbidity results in hundreds of thousands of deaths annually worldwide. Reducing maternal mortality is a key United Nations Millennium Development Goal. Although maternal mortality has declined in high-income countries, contemporary estimates of maternal morbidity and mortality trends in Canada are lacking. METHODS: This population-based study investigated all antepartum, peripartum, and postpartum women presenting to an acute care hospital in Canada from April 1, 2004 to March 31, 2015. The primary outcome was the change in rates of severe maternal morbidity over time. Secondary outcomes included severe maternal mortality and ICU admission, including by province and territory (level of evidence: II2). RESULTS: The cohort comprised 2 035 453 mothers with 3 162 303 pregnancies. There were 17.7 per 1000 episodes of severe maternal morbidity, with annual increases of 1.3% (95% CI 0.60-2.0) for severe maternal morbidity. The maternal mortality rate was 6.2 per 100 000 deliveries and stable over time (estimated percentage of annual change of -0.46%; 95% CI -5.0 to 4.3). The most common causes of severe maternal morbidity were postpartum hemorrhage (5.5 per 1000 deliveries), sepsis (3.8 per 1,000 deliveries), and cardiac failure (1.5 per 1000 deliveries). Severe maternal morbidity varied across Canadian regions but was highest in the Territories at 22.8 per 1000 deliveries. CONCLUSION: Although maternal mortality has been stable in Canada over time, rates of severe maternal morbidity are increasing and are associated with substantial regional variation, with the highest rates experienced by women in the northern Territories.

17.
CMAJ ; 190(22): E669-E676, 2018 Jun 04.
Artigo em Inglês | MEDLINE | ID: mdl-29866892

RESUMO

BACKGROUND: Transfer of patient care from an intensive care unit (ICU) to a hospital ward is often challenging, high risk and inefficient. We assessed patient and provider perspectives on barriers and facilitators to high-quality transfers and recommendations to improve the transfer process. METHODS: We conducted semistructured interviews of participants from a multicentre prospective cohort study of ICU transfers conducted at 10 hospitals across Canada. We purposively sampled 1 patient, 1 family member of a patient, 1 ICU provider, and 1 ward provider at each of the 8 English-speaking sites. Qualitative content analysis was used to derive themes, subthemes and recommendations. RESULTS: The 35 participants described 3 interrelated, overarching themes perceived as barriers or facilitators to high-quality patient transfers: resource availability, communication and institutional culture. Common recommendations suggested to improve ICU transfers included implementing standardized communication tools that streamline provider-provider and provider-patient communication, using multimodal communication to facilitate timely, accurate, durable and mutually reinforcing information transfer; and developing procedures to manage delays in transfer to ensure continuity of care for patients in the ICU waiting for a hospital ward bed. INTERPRETATION: Patient and provider perspectives attribute breakdown of ICU-to-ward transfers of care to resource availability, communication and institutional culture. Patients and providers recommend standardized, multimodal communication and transfer procedures to improve quality of care.

18.
Ann Surg ; 2018 Feb 27.
Artigo em Inglês | MEDLINE | ID: mdl-29489485

RESUMO

OBJECTIVE: To estimate long-term mortality following major burn injury compared with matched controls. SUMMARY BACKGROUND DATA: The effect of sustaining a major burn injury on long-term life expectancy is poorly understood. METHODS: Using health administrative data, all adults who survived to discharge after major burn injury between 2003 and 2013 were matched to between 1 and 5 uninjured controls on age, sex, and the extent of both physical and psychological comorbidity. To account for socioeconomic factors such as residential instability and material deprivation, we also matched on marginalization index. The primary outcome was 5-year all-cause mortality, and all patients were followed until death or March 31, 2014. Cumulative mortality estimates were estimated using the Kaplan-Meier method. Cox proportional hazards modeling was used to estimate the association of burn injury with mortality. RESULTS: In total, 1965 burn survivors of mean age 44 (standard deviation 17) years with median total body surface area burn of 15% [interquartile range (IQR) 5-15] were matched to 8671 controls and followed for a median 5 (IQR 2.5-8) years. Five-year mortality was significantly greater among burn survivors (11 vs 4%, P < 0.001). The hazard ratio was greatest during the first year (4.15, 95% CI 3.17-5.42), and declined each year thereafter, reaching 1.65 (95% CI 1.02-2.67) in the fifth year after discharge. Burn survivors had increased mortality related to trauma (mortality rate ratio, MRR 9.8, 95% CI 5-19) and mental illness (MRR 9.1, 95% CI 4-23). CONCLUSIONS: Burn survivors have a significantly higher rate of long-term mortality than matched controls, particularly related to trauma and mental illness. Burn follow-up should be focused on injury prevention, mental healthcare, and detection and treatment of new disease.

19.
J Crit Care ; 47: 310-319, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29426584

RESUMO

PURPOSE: We systematically reviewed the effects of NIV for acute respiratory failure (ARF) in low- and low-middle income countries. MATERIALS AND METHODS: We searched MEDLINE, CENTRAL, and EMBASE (to January 2016) for observational studies and trials of NIV for ARF or in the peri-extubation period in adults and post-neonatal children. We abstracted outcomes data and assessed quality. Meta-analyses used random-effect models. RESULTS: Fifty-four studies (ten pediatric/n=1099; 44 adult/n=2904), mostly South Asian, were included. Common diagnoses were pneumonia and chronic obstructive pulmonary disease (COPD). Considering observational studies and the NIV arm of trials, NIV was associated with moderate risks of mortality (pooled risk 9.5%, 95% confidence interval (CI) 4.6-14.5% in children; 16.2% [11.2-21.2%] in adults); NIV failure (10.5% [4.6-16.5%] in children; 28.5% [22.4-34.6%] in adults); and intubation (5.3% [0.8-9.7%] in children; 28.8% [21.9-35.8%] in adults). The risk of mortality was greater (p=0.035) in adults with hypoxemic (25.7% [15.2-36.1%]) vs. hypercapneic (12.8% [7.0-18.6%]) ARF. NIV reduced mortality in COPD (relative risk [RR] 0.47 [0.27-0.79]) and in patients weaning from ventilation (RR 0.48 [0.28-0.80]). The pooled pneumothorax risk was 2.4% (0.8-3.9%) in children and 5.2% (1.0-9.4%) in adults. Meta-analyses had high heterogeneity. CONCLUSIONS: NIV for ARF in these settings appears to be effective.

20.
Trials ; 19(1): 81, 2018 Jan 30.
Artigo em Inglês | MEDLINE | ID: mdl-29382391

RESUMO

BACKGROUND: It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-ß1b (IFN-ß1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-ß1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission. METHODS: The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. DISCUSSION: This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02845843 . Registered on 27 July 2016.

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