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2.
J Crit Care ; 82: 154783, 2024 Mar 19.
Artigo em Inglês | MEDLINE | ID: mdl-38507842

RESUMO

BACKGROUND: Hospital acquired infections (HAI) and liberal use of broad-spectrum antibiotics are common in intensive care unit(ICU)s of low-middle income countries. We investigated the long-term association of a stepwise multifaceted educational program with the incidence of HAIs and antibiotics use in a Brazilian ICU. We also evaluated the program's cost impact. METHODS: We retrieved data from a prospective daily collected database of a twelve bedrooms ICU, all admitted patients within a period of eleven years were enrolled. FINDINGS: From 03/15/2007 to 09/11/2019, we admitted 3059 patients where 2406 (79%) survived the ICU stay. Median age was 51 years-old, and median SAPS3 was 53. The initial density of catheter related blood infection (4.3 events / 1000 patients-day), urinary tract infection (9.2 event / 1000 patients-day) and ventilator associated pneumonia (54.9 events / 1000 patients-day) felt during the observed period to (0.35 events / 1000 patients-day), (0 events / 1000 patients-day), and (1.5 events / 1000 patients-day) respectively. The days of antibiotic therapy also decreased from 797.9 days of therapy / 1000 patients day to 292.3 days of therapy / 1000 patients day. The total cost per patient also decreased. The adjusted mortality rate was steady during the studied period from 23.2% to 22.9%. INTERPRETATION: A stepwise multifaceted educational program is an effective way to reduce hospital-associated infections, improve the rational use of antibiotics, and reduce costs. This impact occurred in a long term, and is probably consistent.

3.
Lancet Infect Dis ; 2024 Mar 11.
Artigo em Inglês | MEDLINE | ID: mdl-38484749

RESUMO

This Personal View discusses the challenges faced, especially by low-income and middle-income countries (LMICs), in responding to the growing burden of bacterial antimicrobial resistance. Many patients in LMICs lack access to effective and affordable treatments needed to successfully treat patients. Meanwhile, traditional antimicrobial stewardship models face implementation challenges due to financial, health system, and human resource constraints. These constraints call for a paradigm shift from traditional high-income country-style antimicrobial stewardship, which is often resource intensive and aimed at cost containment, to a broader concept of sustainable access. We suggest a model of context-adapted stewardship that continues to emphasise providing the right antibiotic, at the right time, for the right duration, and at an affordable price. Taking lessons from other disease areas, including tuberculosis, we identify interventions such as task shifting to various health-care workers and the implementation of a hub-and-spoke model to support appropriate use of antibiotics, to enable optimal access and maximisation of scarce resources.

4.
Clin Infect Dis ; 77(Suppl 1): S4-S11, 2023 07 05.
Artigo em Inglês | MEDLINE | ID: mdl-37406043

RESUMO

BACKGROUND: High rates of antibiotic use (AU) among inpatients with coronavirus disease 2019 (COVID-19) despite low rates of bacterial coinfection and secondary infection have been reported. We evaluated the impact of the COVID-19 pandemic on AU in healthcare facilities (HCFs) in South America. METHODS: We conducted an ecologic evaluation of AU in inpatient adult acute care wards in 2 HCFs each in Argentina, Brazil, and Chile. The AU rates for intravenous antibiotics were calculated as the defined daily dose per 1000 patient-days, using pharmacy dispensing records and hospitalization data from March 2018-February 2020 (prepandemic) and March 2020-February 2021 (pandemic). Differences in median AU were compared between the prepandemic and pandemic periods, using the Wilcoxon rank sum test to determine significance. Interrupted time series analysis was used to analyze changes in AU during the COVID-19 pandemic. RESULTS: Compared with the prepandemic period, the median difference in AU rates for all antibiotics combined increased in 4 of 6 HCFs (percentage change, 6.7%-35.1%; P < .05). In the interrupted time series models, 5 of 6 HCFs had significant increases in use of all antibiotics combined immediately at the onset of the pandemic (immediate effect estimate range, 15.4-268), but only 1 of these 5 HCFs experienced a sustained increase over time (change in slope, +8.13; P < .01). The effect of the pandemic onset varied by antibiotic group and HCF. CONCLUSIONS: Substantial increases in AU were observed at the beginning of the COVID-19 pandemic, suggesting the need to maintain or strengthen antibiotic stewardship activities as part of pandemic or emergency HCF responses.


Assuntos
Antibacterianos , COVID-19 , Humanos , Adulto , Antibacterianos/uso terapêutico , COVID-19/epidemiologia , Pacientes Internados , Pandemias , Chile/epidemiologia , Argentina/epidemiologia , Brasil
5.
Clin Infect Dis ; 77(Suppl 1): S46-S52, 2023 07 05.
Artigo em Inglês | MEDLINE | ID: mdl-37406046

RESUMO

BACKGROUND: Overcrowded emergency departments (EDs) may increase the risk of carbapenem-resistant Enterobacterales (CRE) transmission. METHODS: We conducted a quasi-experimental study divided into 2 phases (baseline and intervention) to investigate the impact of an intervention on the acquisition rate and identify risk factors for CRE colonization in an ED of a tertiary academic hospital in Brazil. In both phases, we did universal screening with rapid molecular test (blaKPC, blaNDM, blaOXA48, blaOXA23, and blaIMP) and culture. At baseline, both screening test results were not reported, and patients were put under contact precautions (CP) based on previous colonization or infection by multidrug-resistant organisms. During the intervention, all patients hospitalized in the ED were placed in empiric CP and the result of CRE screening was reported; if negative, patients were released from CP. Patients were rescreened if they stayed >7 days in the ED or were transferred to an intensive care unit. RESULTS: A total of 845 patients were included: 342 in baseline and 503 in intervention. Colonization at admission was 3.4% by culture and molecular test. Acquisition rates during ED stay dropped from 4.6% (11/241) to 1% (5/416) during intervention (P = .06). The aggregated antimicrobial use in the ED decreased from phase 1 to phase 2 (804 defined daily doses [DDD]/1000 patients to 394 DDD/1000 patients, respectively). Length of stay >2 days in the ED was a risk factor for CRE acquisition (adjusted odds ratio, 4.58 [95% confidence interval, 1.44-14.58]; P = .01). CONCLUSIONS: Early empiric CP and rapid identification of CRE-colonized patients reduce cross-transmission in ED. Nevertheless, staying >2 days in ED compromised efforts.


Assuntos
Enterobacteriáceas Resistentes a Carbapenêmicos , Infecções por Enterobacteriaceae , Humanos , Carbapenêmicos/farmacologia , Centros de Atenção Terciária , Controle de Infecções , Serviço Hospitalar de Emergência , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Infecções por Enterobacteriaceae/tratamento farmacológico , Infecções por Enterobacteriaceae/epidemiologia , Infecções por Enterobacteriaceae/diagnóstico
6.
Clin Infect Dis ; 77(Suppl 1): S62-S69, 2023 07 05.
Artigo em Inglês | MEDLINE | ID: mdl-37406048

RESUMO

BACKGROUND: Our aim in this retrospective cohort study was to assess the impact on mortality of the empirical use of polymyxin as therapy for carbapenem-resistant gram-negative bacteria (CR-GNB) in septic patients. The study was performed at a tertiary academic hospital in Brazil, from January 2018 to January 2020, the pre-coronavirus disease 2019 period. METHODS: We included 203 patients with suspected sepsis. The first doses of antibiotics were prescribed from a "sepsis antibiotic kit", which contained a selection of drugs, including polymyxin, with no preapproval policy. We developed a logistic regression model to assess risk factors associated with 14-day crude mortality. Propensity score for polymyxin was used to control biases. RESULTS: Seventy (34%) of 203 patients had infections with at least 1 multidrug-resistant organism isolated from any clinical culture. Polymyxins in monotherapy or in combination therapy were prescribed to 140 of the 203 (69%) patients. The overall 14-day mortality rate was 30%. The 14-day crude mortality was associated with age (adjusted odds ratio [aOR], 1.03; 95% confidence interval [CI], 1.01-1.05; P = .01), SOFA (sepsis-related organ failure assessment) score value (aOR, 1.2; 95% CI, 1.09-1.32; P < .001), CR-GNB infection (aOR, 3.94; 95% CI, 1.53-10.14; P = .005), and time between suspected sepsis and antibiotic administration (aOR, 0.73; 95% CI, .65-.83; P < .001). The empirical use of polymyxins was not associated with decreased crude mortality (aOR, 0.71; 95% CI, .29-1.71; P = .44). CONCLUSIONS: Empirical use of polymyxin for septic patients in a setting with high CR-GNB prevalence was not associated with decreased crude mortality.


Assuntos
COVID-19 , Infecções por Bactérias Gram-Negativas , Sepse , Humanos , Polimixinas/uso terapêutico , Carbapenêmicos/farmacologia , Carbapenêmicos/uso terapêutico , Estudos Retrospectivos , Antibacterianos/uso terapêutico , Bactérias Gram-Negativas , Sepse/tratamento farmacológico , Sepse/epidemiologia , Infecções por Bactérias Gram-Negativas/tratamento farmacológico , Infecções por Bactérias Gram-Negativas/epidemiologia , Infecções por Bactérias Gram-Negativas/microbiologia
7.
Antibiotics (Basel) ; 12(5)2023 May 21.
Artigo em Inglês | MEDLINE | ID: mdl-37237838

RESUMO

Regulatory authorities authorize the clinical use of generic drugs (GD) based on bioequivalence studies, which consist of the evaluation of pharmacokinetics after a single dose in vitro or in healthy individuals. There are few data on clinical equivalence between generic and branded antibiotics. Our aim was to synthesize and analyze the available evidence on the clinical efficacy and safety of generic antibiotics compared to their original formulations. A systematic review was performed on Medline (PubMed) and Embase and validated through Epistemonikos and Google Scholar. The last search was conducted on 30 June 2022. Meta-analyses of clinical cure and mortality outcomes were performed. One randomized clinical trial (RCT) and 10 non-randomized intervention studies were included. No differences in clinical cure were observed between groups in the meta-analysis (OR = 0.89, 95% CI [0.61-1.28]; I2 = 70%, p = 0.005). No difference was observed between groups when considering the use of carbapenems for overall mortality (OR = 0.99, 95% CI [0.63-1.55]; I2 = 78%) or death associated with infections (OR = 0.79, 95% CI [0.48-1.29], I2 = 67%). Most of the studies were observational, and the duration of follow-up, the characteristics of the participants, and the sites of infections were heterogeneous. Due to the uncertainty of the evidence, it is not possible to contraindicate the use of generics, which is an important strategy to expand access.

8.
EClinicalMedicine ; 60: 102004, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-37223666

RESUMO

Background: COVID-19 progression is associated with an increased risk of arterial and venous thrombosis. Randomised trials have demonstrated that anticoagulants reduce the risk of thromboembolism in hospitalised patients with COVID-19, but a benefit of routine anticoagulation has not been demonstrated in the outpatient setting. Methods: We conducted a randomised, open-label, controlled, multicentre study, evaluating the use of rivaroxaban in mild or moderate COVID-19 patients. Adults ≥18 years old, with probable or confirmed SARS-CoV-2 infection, presenting within ≤7 days from symptom onset with no clear indication for hospitalization, plus at least 2 risk factors for complication, were randomised 1:1 either to rivaroxaban 10 mg OD for 14 days or to routine care. The primary efficacy endpoint was the composite of venous thromboembolic events, need of mechanical ventilation, acute myocardial infarction, stroke, acute limb ischemia, or death due to COVID-19 during the first 30 days. ClinicalTrials.gov: NCT04757857. Findings: Enrollment was prematurely stopped due to sustained reduction in new COVID-19 cases. From September 29th, 2020, through May 23rd, 2022, 660 patients were randomised (median age 61 [Q1-Q3 47-69], 55.7% women). There was no significant difference between rivaroxaban and control in the primary efficacy endpoint (4.3% [14/327] vs 5.8% [19/330], RR 0.74; 95% CI: 0.38-1.46). There was no major bleeding in the control group and 1 in the rivaroxaban group. Interpretation: On light of these findings no decision can be made about the utility of rivaroxaban to improve outcomes in outpatients with COVID-19. Metanalyses data provide no evidence of a benefit of anticoagulant prophylaxis in outpatients with COVID-19. These findings were the result of an underpowered study, therefore should be interpreted with caution. Funding: COALITION COVID-19 Brazil and Bayer S.A.

9.
Infect Control Hosp Epidemiol ; 44(10): 1555-1561, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37039458

RESUMO

OBJECTIVE: In this study, we described the first results of a surveillance system for infections associated with long-term central venous catheters (LT-CVC) in patients under outpatient chemotherapy. DESIGN: This was a multicentric, prospective study. SETTING: Outpatient chemotherapy services. PARTICIPANTS: The study included 8 referral cancer centers in the State of São Paulo. INTERVENTION: These services were invited to participate in a newly created surveillance program for patients under chemotherapy. Several meetings were convened to share previous experiences on LT-CVC infection surveillance and to define the surveillance method. Once the program was implemented, all bloodstream infection (LT-CVC BSIs), tunnel infection, and exit-site infections associated with LT-CVC were reported. Data from January to May 2021 were analyzed. The median monthly number of chemotherapy sessions per clinic was 925 (IQR, 270-5,855). We used Poisson regression to analyze the association of rates with the characteristics of the services. RESULTS: In total, 107 LT-CVC infections were reported, of which 95% were BSIs, mostly associated with totally implantable devices (76%). Infections occurred a median of 4 days after the last catheter manipulation and 116 after the LT-CVC insertion. Also, 102 microorganisms were isolated from LT-CVC BSIs; the most common pathogen was Staphylococcus epidermidis, at 22%. Moreover, 44 infections (44%) fulfilled the criteria for CVC-related LT-CVC BSI and 27 infections (27%) met the criteria for mucosal barrier injury. The 1-year cumulative LT-CVC BSI rate was 1.94 per 1,000 CVC days of use. The rates were higher in public hospitals (IRR, 6.00; P < .001) and in hospitals that already had in place surveillance for LT-CVC infections (IRR, 2.01; P < .01). CONCLUSION: Our study describes an applicable surveillance method for infections in cancer outpatients using LT-CVC.


Assuntos
Infecções Relacionadas a Cateter , Cateterismo Venoso Central , Cateteres Venosos Centrais , Sepse , Humanos , Brasil/epidemiologia , Infecções Relacionadas a Cateter/epidemiologia , Infecções Relacionadas a Cateter/etiologia , Cateterismo Venoso Central/efeitos adversos , Cateteres Venosos Centrais/efeitos adversos , Pacientes Ambulatoriais , Estudos Prospectivos , Sepse/etiologia
11.
Lancet Reg Health Am ; 11: 100243, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35378952

RESUMO

Background: Previous Randomised controlled trials (RCT) evaluating chloroquine and hydroxychloroquine in non-hospitalised COVID-19 patients have found no significant difference in hospitalisation rates. However, low statistical power precluded definitive answers. Methods: We conducted a multicenter, double-blind, RCT in 56 Brazilian sites. Adults with suspected or confirmed COVID-19 presenting with mild or moderate symptoms with ≤ 07 days prior to enrollment and at least one risk factor for clinical deterioration were randomised (1:1) to receive hydroxychloroquine 400 mg twice a day (BID) in the first day, 400 mg once daily (OD) thereafter for a total of seven days, or matching placebo. The primary outcome was hospitalisation due to COVID-19 at 30 days, which was assessed by an adjudication committee masked to treatment allocation and following the intention-to-treat (ITT) principle. An additional analysis was performed only in participants with SARS-CoV-2 infection confirmed by molecular or serology testing (modified ITT [mITT] analysis). This trial was registered at ClinicalTrials.gov, NCT04466540. Findings: From May 12, 2020 to July 07, 2021, 1372 patients were randomly allocated to hydroxychloroquine or placebo. There was no significant difference in the risk of hospitalisation between hydroxychloroquine and placebo groups (44/689 [6·4%] and 57/683 [8·3%], RR 0·77 [95% CI 0·52-1·12], respectively, p=0·16), and similar results were found in the mITT analysis with 43/478 [9·0%] and 55/471 [11·7%] events, RR 0·77 [95% CI 0·53-1·12)], respectively, p=0·17. To further complement our data, we conducted a meta-analysis which suggested no significant benefit of hydroxychloroquine in reducing hospitalisation among patients with positive testing (69/1222 [5·6%], and 88/1186 [7·4%]; RR 0·77 [95% CI 0·57-1·04]). Interpretation: In outpatients with mild or moderate forms of COVID-19, the use of hydroxychloroquine did not reduce the risk of hospitalisation compared to the placebo control. Our findings do not support the routine use of hydroxychloroquine for treatment of COVID-19 in the outpatient setting. Funding: COALITION COVID-19 Brazil and EMS.

12.
Arq Bras Cardiol ; 118(2): 378-387, 2022 02.
Artigo em Inglês, Português | MEDLINE | ID: mdl-35262569

RESUMO

BACKGROUND: Despite the need for targeting specific therapeutic options for coronavirus disease 2019 (COVID-19), there has been no evidence of effectiveness of any specific treatment for the outpatient clinical setting. There are few randomized studies evaluating hydroxychloroquine (HCQ) in non-hospitalized patients. These studies indicate no benefit from the use of HCQ, but they assessed different primary outcomes and presented important biases for outcome evaluation. OBJECTIVE: To evaluate if HCQ may prevent hospitalization due to COVID-19 compared to a matching placebo. METHODS: The COVID-19 Outpatient Prevention Evaluation (COPE) study is a pragmatic, randomized, double-blind, placebo-controlled clinical trial evaluating the use of HCQ (800 mg on day 1 and 400 mg from day 2 to day 7) or matching placebo for the prevention of hospitalization due to COVID-19 in early non-hospitalized confirmed or suspected cases. Inclusion criteria are adults (≥ 18 years) seeking medical care with mild symptoms of COVID-19, with randomization ≤ 7 days after symptom onset, without indication of hospitalization at study screening, and with at least one risk factor for complication (> 65 years; hypertension; diabetes mellitus; asthma; chronic obstructive pulmonary disease or other chronic lung diseases; smoking; immunosuppression; or obesity). All hypothesis tests will be two-sided. A p-value < 0.05 will be considered statistically significant in all analyses. Clinicaltrials.gov: NCT04466540. RESULTS: Clinical outcomes will be centrally adjudicated by an independent clinical event committee blinded to the assigned treatment groups. The primary efficacy endpoint will be assessed following the intention-to-treat principle. CONCLUSION: This study has the potential to reliably answer the scientific question of HCQ use in outpatients with COVID-19. To our knowledge, this is the largest trial evaluating HCQ in non-hospitalized individuals with COVID-19.


FUNDAMENTO: Apesar da necessidade de opções terapêuticas específicas para a doença do coronavírus 2019 (covid-19), ainda não há evidências da eficácia de tratamentos específicos no contexto ambulatorial. Há poucos estudos randomizados que avaliam a hidroxicloroquina (HCQ) em pacientes não hospitalizados. Esses estudos não indicaram benefício com o uso da HCQ; no entanto, avaliaram desfechos primários diferentes e apresentaram vieses importantes na avaliação dos desfechos. OBJETIVO: Investigar se a HCQ possui o potencial de prevenir hospitalizações por covid-19 quando comparada ao placebo correspondente. MÉTODOS: O estudo COVID-19 Outpatient Prevention Evaluation (COPE) é um ensaio clínico randomizado, pragmático, duplo-cego, multicêntrico e controlado por placebo que avalia o uso da HCQ (800 mg no dia 1 e 400 mg do dia 2 ao dia 7) ou placebo correspondente na prevenção de hospitalizações por covid-19 em casos precoces confirmados ou suspeitos de pacientes não hospitalizados. Os critérios de inclusão são adultos (≥ 18 anos) que procuraram atendimento médico com sintomas leves de covid-19, com randomização ≤ 7 dias após o início dos sintomas, sem indicação de hospitalização na triagem do estudo e com pelo menos um fator de risco para complicações (> 65 anos, hipertensão, diabetes melito, asma, doença pulmonar obstrutiva crônica ou outras doenças pulmonares crônicas, tabagismo, imunossupressão ou obesidade). Todos os testes de hipótese serão bilaterais. Um valor de p < 0,05 será considerado estatisticamente significativo em todas as análises. Clinicaltrials.gov: NCT04466540. RESULTADOS: Os desfechos clínicos serão avaliados centralmente por um comitê de eventos clínicos independente cegado para a alocação dos grupos de tratamento. O desfecho primário de eficácia será avaliado de acordo com o princípio da intenção de tratar. CONCLUSÃO: Este estudo apresenta o potencial de responder de forma confiável a questão científica do uso da HCQ em pacientes ambulatoriais com covid-19. Do nosso conhecimento, este é o maior estudo avaliando o uso de HCQ em indivíduos com covid-19 não hospitalizados.


Assuntos
Tratamento Farmacológico da COVID-19 , Hidroxicloroquina , Adulto , Humanos , Hidroxicloroquina/efeitos adversos , Hidroxicloroquina/uso terapêutico , Pacientes Ambulatoriais , SARS-CoV-2 , Resultado do Tratamento
13.
Microbes Infect ; 24(5): 104953, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35217192

RESUMO

Clostridioides difficile (CD) is the most frequent cause of healthcare related diarrhea and its severity has increased in the last decade by the spread of hypervirulent strains. Most important CD virulence factor is toxin production; however, not only toxins are responsible for Clostridioides virulence. We sequenced 38 strains and analyzed the presence and integrity of 24 virulence (including toxin) genes. We identified 28 toxigenic strains, six also presented the cdt genes. Only six strains didn't present all others genes searched. All absent genes were adhesion related. Understand others CD virulence factors can lead to a best understanding on this matter.


Assuntos
Toxinas Bacterianas , Clostridioides difficile , Infecções por Clostridium , Toxinas Bacterianas/genética , Brasil , Clostridioides , Clostridioides difficile/genética , Hospitais , Humanos , Virulência/genética , Fatores de Virulência/genética , Sequenciamento Completo do Genoma
14.
Emerg Infect Dis ; 28(1): 180-187, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34932455

RESUMO

Although restricting over-the-counter (OTC) antimicrobial drug sales is recommended globally, no data track its effect on antimicrobial resistance (AMR) in bacteria. We evaluated the effect of a national policy restricting OTC antimicrobial sales, put in place in November 2010, on AMR in a metropolitan region of São Paulo, Brazil. We reviewed associations between antimicrobial sales from private pharmacies and AMR in 404,558 Escherichia coli and 5,797 Streptococcus pneumoniae isolates using a dynamic regression model based on a Bayesian approach. After policy implementation, a substantial drop in AMR in both bacterial species followed decreased amoxicillin and trimethoprim/sulfamethoxazole sales. Conversely, increased ciprofloxacin sales were associated with increased ciprofloxacin resistance, and extended spectrum ß-lactamases-positive E. coli isolates and azithromycin sales increases after 2013 were associated with increased erythromycin resistance in S. pneumoniae isolates. These findings suggest that restricting OTC antimicrobial sales may influence patterns of AMR, but multifaceted approaches are needed to avoid unintended consequences.


Assuntos
Antibacterianos , Anti-Infecciosos , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Teorema de Bayes , Brasil/epidemiologia , Farmacorresistência Bacteriana , Escherichia coli , Testes de Sensibilidade Microbiana , Políticas
15.
Arq. bras. cardiol ; 118(2): 378-387, 2022. tab, graf
Artigo em Inglês, Português | LILACS | ID: biblio-1364322

RESUMO

Resumo Fundamento Apesar da necessidade de opções terapêuticas específicas para a doença do coronavírus 2019 (covid-19), ainda não há evidências da eficácia de tratamentos específicos no contexto ambulatorial. Há poucos estudos randomizados que avaliam a hidroxicloroquina (HCQ) em pacientes não hospitalizados. Esses estudos não indicaram benefício com o uso da HCQ; no entanto, avaliaram desfechos primários diferentes e apresentaram vieses importantes na avaliação dos desfechos. Objetivo Investigar se a HCQ possui o potencial de prevenir hospitalizações por covid-19 quando comparada ao placebo correspondente. Métodos O estudo COVID-19 Outpatient Prevention Evaluation (COPE) é um ensaio clínico randomizado, pragmático, duplo-cego, multicêntrico e controlado por placebo que avalia o uso da HCQ (800 mg no dia 1 e 400 mg do dia 2 ao dia 7) ou placebo correspondente na prevenção de hospitalizações por covid-19 em casos precoces confirmados ou suspeitos de pacientes não hospitalizados. Os critérios de inclusão são adultos (≥ 18 anos) que procuraram atendimento médico com sintomas leves de covid-19, com randomização ≤ 7 dias após o início dos sintomas, sem indicação de hospitalização na triagem do estudo e com pelo menos um fator de risco para complicações (> 65 anos, hipertensão, diabetes melito, asma, doença pulmonar obstrutiva crônica ou outras doenças pulmonares crônicas, tabagismo, imunossupressão ou obesidade). Todos os testes de hipótese serão bilaterais. Um valor de p < 0,05 será considerado estatisticamente significativo em todas as análises. Clinicaltrials.gov: NCT04466540. Resultados Os desfechos clínicos serão avaliados centralmente por um comitê de eventos clínicos independente cegado para a alocação dos grupos de tratamento. O desfecho primário de eficácia será avaliado de acordo com o princípio da intenção de tratar. Conclusão Este estudo apresenta o potencial de responder de forma confiável a questão científica do uso da HCQ em pacientes ambulatoriais com covid-19. Do nosso conhecimento, este é o maior estudo avaliando o uso de HCQ em indivíduos com covid-19 não hospitalizados.


Abstract Background Despite the need for targeting specific therapeutic options for coronavirus disease 2019 (COVID-19), there has been no evidence of effectiveness of any specific treatment for the outpatient clinical setting. There are few randomized studies evaluating hydroxychloroquine (HCQ) in non-hospitalized patients. These studies indicate no benefit from the use of HCQ, but they assessed different primary outcomes and presented important biases for outcome evaluation. Objective To evaluate if HCQ may prevent hospitalization due to COVID-19 compared to a matching placebo. Methods The COVID-19 Outpatient Prevention Evaluation (COPE) study is a pragmatic, randomized, double-blind, placebo-controlled clinical trial evaluating the use of HCQ (800 mg on day 1 and 400 mg from day 2 to day 7) or matching placebo for the prevention of hospitalization due to COVID-19 in early non-hospitalized confirmed or suspected cases. Inclusion criteria are adults (≥ 18 years) seeking medical care with mild symptoms of COVID-19, with randomization ≤ 7 days after symptom onset, without indication of hospitalization at study screening, and with at least one risk factor for complication (> 65 years; hypertension; diabetes mellitus; asthma; chronic obstructive pulmonary disease or other chronic lung diseases; smoking; immunosuppression; or obesity). All hypothesis tests will be two-sided. A p-value < 0.05 will be considered statistically significant in all analyses. Clinicaltrials.gov: NCT04466540. Results Clinical outcomes will be centrally adjudicated by an independent clinical event committee blinded to the assigned treatment groups. The primary efficacy endpoint will be assessed following the intention-to-treat principle. Conclusion This study has the potential to reliably answer the scientific question of HCQ use in outpatients with COVID-19. To our knowledge, this is the largest trial evaluating HCQ in non-hospitalized individuals with COVID-19.


Assuntos
Humanos , Adulto , COVID-19/tratamento farmacológico , Hidroxicloroquina/efeitos adversos , Hidroxicloroquina/uso terapêutico , Pacientes Ambulatoriais , Resultado do Tratamento , SARS-CoV-2
16.
Recurso educacional aberto em Português | CVSP - Regional | ID: oer-3964

RESUMO

O Momento com o GTEE COVID-19 foi criado em fevereiro de 2021 pelo subgrupo de retomada do Grupo de Trabalho da Escola de Enfermagem da Universidade de São Paulo contra a COVID-19 (GTEE COVID-19), com o objetivo de esclarecer as dúvidas sobre a pandemia da COVID-19 e atualizar as informações sobre as ações do GTEE COVID-19.


Assuntos
Infecções por Coronavirus , COVID-19 , Prevenção de Doenças , Máscaras , Pandemias
17.
Artigo em Inglês | MEDLINE | ID: mdl-34586308

RESUMO

Mobile phones (MPs) have become an important work tool around the world including in hospitals. We evaluated whether SARS-CoV-2 can remain on the surface of MPs of first-line healthcare workers (HCW) and also the knowledge of HCWs about SARS-CoV-2 cross-transmission and conceptions on the virus survival on the MPs of HCWs. A cross-sectional study was conducted in the COVID-19 Intensive Care Unit of a teaching hospital. An educational campaign was carried out on cross-transmission of SARS-CoV-2, and its permanence in fomites, in addition to the proper use and disinfection of MPs. Herewith an electronic questionnaire was applied including queried conceptions about hand hygiene and care with MP before and after the pandemic. The MPs were swabbed with a nylon FLOQ Swab™, in an attempt to increase the recovery of SARS-CoV-2. All MP swab samples were subjected to SARS-CoV-2 RT-PCR; RT-PCR positive samples were subjected to viral culture in Vero cells (ATCC® CCL-81™). Fifty-one MPs were swabbed and a questionnaire on hand hygiene and the use and disinfection of MP was applied after an educational campaign. Most HCWs increased adherence to hand hygiene and MP disinfection during the pandemic. Fifty-one MP swabs were collected and two were positive by RT-PCR (4%), with Cycle threshold (Ct ) values of 34-36, however, the cultures of these samples were negative. Although most HCWs believed in the importance of cross-transmission and increased adherence to hand hygiene and disinfection of MP during the pandemic, SARS-CoV-2 RNA was detected in MPs. Our results suggest the need for a universal policy in infection control guidelines on how to care for electronic devices in hospital settings.


Assuntos
COVID-19 , Telefone Celular , Animais , Chlorocebus aethiops , Estudos Transversais , Hospitais , Humanos , RNA Viral , SARS-CoV-2 , Células Vero
18.
Diagn Microbiol Infect Dis ; 101(2): 115344, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34243136

RESUMO

Ventilator associated pneumonia(VAP) is a severe complication that can lead to high mortality when not early identified or when therapy is delayed. The aim of this study was to evaluate procalcitonin(PCT) as a biomarker for VAP development. In total, 73 hospitalized patients with COVID-19 were analyzed. PCT levels greater than 0.975ng/mL were more related to VAP. No association was found for C-reactive protein (CRP). The results show that procalcitonin may be a pertinent biomarker for VAP diagnosis and can be a helpful tool for antibiotic withdrawal.


Assuntos
Gestão de Antimicrobianos/métodos , COVID-19/diagnóstico , Pneumonia Associada à Ventilação Mecânica/diagnóstico , Pró-Calcitonina/sangue , Adulto , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/uso terapêutico , Biomarcadores/sangue , COVID-19/complicações , Feminino , Humanos , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Pneumonia Associada à Ventilação Mecânica/complicações , Pneumonia Associada à Ventilação Mecânica/tratamento farmacológico , Curva ROC , SARS-CoV-2 , Tratamento Farmacológico da COVID-19
19.
Eur J Clin Microbiol Infect Dis ; 40(9): 1821-1832, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33783664

RESUMO

Little is known about the role of lineage of strains of Clostridioides difficile (CD) on the clinical presentation of CD infection (CDI) in Latin America, especially regarding the treatment response. We conducted a multicenter, prospective study to investigate the predictive factors and treatment outcomes of CDI in hospitalized patients and to performed phenotypical and molecular characterization of CD strains. A total of 361 diarrheic patients at 5 hospitals from different regions of the country were enrolled. All stool samples were tested for glutamate dehydrogenase (GDH), toxins A and B, and toxin genes using a nucleic acid amplification test (NAAT). Specimens were cultured and susceptibility profile and whole-genome sequencing (WGS) were performed. CDI positivity was 15% (56/377). Predictive factors for CDI were prior use of meropenem (OR 4.09, 95% CI 2.097-7.095; p<0.001), mucus in stools (OR 3.29; 95% CI 1.406-7.722; p=0.006) and neutrophil left-shift with >20% of bands (OR 3.77; 95% IC 1.280-11.120; p=0.016). Overall mortality was 19%, with no deaths attributed to CDI. Oral metronidazole was used in 74% of cases, with 85% of cure and 14% of recurrence. A total of 35 CD isolates were recovered, all of them susceptible to metronidazole and vancomycin. The WGS revealed 17 different STs, six of which were novel. ST42 was the most common ST and hypervirulent strains were not found. Severe CDI were caused by ST42, ST5, ST8, ST48, ST33 and a novel ST667. The ermB gene was more frequently found in isolates of ST42 (p=0.004).


Assuntos
Antibacterianos/uso terapêutico , Clostridioides difficile/genética , Infecções por Clostridium/tratamento farmacológico , Infecções por Clostridium/epidemiologia , Diarreia/microbiologia , Adulto , Idoso , Proteínas de Bactérias/genética , Brasil/epidemiologia , Clostridioides difficile/classificação , DNA Bacteriano/genética , Fezes/microbiologia , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , Sequenciamento Completo do Genoma
20.
Clinics (Sao Paulo) ; 76: e2284, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33503188

RESUMO

OBJECTIVES: Bacterial and aseptic meningitis after neurosurgery can present similar clinical signs and symptoms. The aims of this study were to develop and test a molecular method to diagnose bacterial meningitis (BM) after neurosurgery. METHODS: A 16S ribosomal RNA gene PCR-based strategy was developed using artificially inoculated cerebrospinal fluid (CSF) followed by sequencing. The method was tested using CSF samples from 43 patients who had undergone neurosurgery and were suspected to suffer from meningitis, and from 8 patients without neurosurgery or meningitis. Patients were classified into five groups, confirmed BM, probable BM, possible BM, unlikely BM, and no meningitis. RESULTS: Among the samples from the 51 patients, 21 samples (41%) were culture-negative and PCR-positive. Of these, 3 (14%) were probable BM, 4 (19%) were possible BM, 13 (62%) were unlikely BM, and 1 (5%) was meningitis negative. Enterobacterales, non-fermenters (Pseudomonas aeruginosa and Acinetobacter baumannii), Staphylococcus haemolyticus, Granulicatella, Variovorax, and Enterococcus cecorum could be identified. In the group of patients with meningitis, a good agreement (3 of 4) was observed with the results of cultures, including the identification of species. CONCLUSION: Molecular methods may complement the diagnosis, guide treatment, and identify non-cultivable microorganisms. We suggest the association of methods for suspected cases of BM after neurosurgery, especially for instances in which the culture is negative.


Assuntos
Meningites Bacterianas , Neurocirurgia , Enterococcus , Humanos , Meningites Bacterianas/diagnóstico , Reação em Cadeia da Polimerase , RNA Ribossômico 16S/genética , Sensibilidade e Especificidade
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