9 research outputs found

    Empirical metronidazole for patients with severe bacterial infection:A systematic review with meta-analysis and trial sequential analysis

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    Background: Metronidazole is the preferred empirical anti-anaerobic agent for patients with suspected anaerobic infection. The balance between benefits and harms of empirical metronidazole is unclear. We aimed to assess patient-important benefits and harms of empirical metronidazole vs placebo/no treatment in adult patients with severe bacterial infection of any origin. Methods: We conducted a systematic review with meta-analysis and trial sequential analysis of randomized clinical trials assessing empirical metronidazole vs placebo/no treatment in adult hospitalized patients with severe bacterial infection. The review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement, the Cochrane Handbook and the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology. A protocol and statistical analysis plan was published prior to conducting the review. Results: We included a total of nine trials (n = 1753 patients), all of which were adjudicated as having high risk of bias. We found no difference in the primary outcome mortality within 90 days (relative risk 1.56, 95% confidence interval 0.39-6.25). Fewer patients receiving metronidazole had secondary infections (relative risk 0.43, 95% CI: 0.27-0.68). Trial sequential analysis indicated high risk of random errors due to lack of data, and the quality of evidence was very low for all outcomes. Conclusions: There is low quantity and quality of evidence supporting the use of empirical metronidazole in adult patients with severe bacterial infections of any origin, and no firm evidence for benefit or harm

    Piperacillin/tazobactam vs carbapenems for patients with bacterial infection:Protocol for a systematic review

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    INTRODUCTION: Early empirical broad-spectrum antimicrobial therapy is recommended for patients with severe infections, including sepsis. β-lactam/β-lactamase inhibitor combinations or carbapenems are often used to ensure coverage of likely pathogens. Piperacillin/tazobactam is proposed as a carbapenem-sparing agent to reduce the incidence of multidrug-resistant bacteria and superinfections. In the recently published MERINO trial, increased mortality from piperacillin/tazobactam was suggested in patients with bacteraemia with resistant Escherichia coli or Klebsiella species. Whether these findings also apply to empirical piperacillin/tazobactam in patients with other severe infections, including sepsis, is unknown. We aim to assess the benefits and harms of empirical and definitive piperacillin/tazobactam vs carbapenems for patients with severe bacterial infections.METHODS AND ANALYSIS: This protocol has been prepared according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols statement, the Cochrane Handbook and the Grading of Recommendations, Assessment, Development, and Evaluation approach. We will include randomised clinical trials assessing piperacillin/tazobactam vs carbapenems in patients with severe bacterial infections of any origin. The primary outcome will be all-cause short-term mortality ≤ 90 days. Secondary outcomes will include all-cause long-term mortality > 90 days, adverse events, quality of life, use of life support, secondary infections, antibiotic resistance, and length of stay. We will conduct meta-analyses, including pre-planned subgroup and sensitivity analyses for all assessed outcomes. The risk of random errors in the meta-analyses will be assessed by trial sequential analysis

    Time trends in the reporting of conflicts of interest, funding and affiliation with industry in intensive care research: a systematic review

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    International audiencePurpose : Conflict of interest (COI) may compromise, or have the appearance of compromising, a researcher’s judgment or integrity in conducting or reporting research. We sought to assess time trends of COI and funding statement reporting in the critical care literature.Methods : PubMed was searched by using Medical Subject Headings and the appropriate corresponding keywords: “INTENSIVE CARE UNIT” or “ICU” as a major topic. Four years in a 15-year time period (2001–2016) were arbitrarily chosen and one study month was randomly selected for each study period. Studies published during the selected months were included in the analysis.Results : Three hundred and seventy-four studies were evaluated, including five reviews (1.3%) and ten randomized clinical trials (RCTs) (2.7%). COI statements were available in 65% of the studies and 8% had declared COI. COI statement rate, declared COI and funding statements increased over time, while the number of authors affiliated with industry and the discordance between the lack of COI statement and affiliation with industry decreased. Declared COI were more frequent in 2011–2016 as compared to 2001–2010 (OR 4.06; 95% CI 1.15–25.79) and in the higher quartile of a journal’s impact factor (OR of 16.73; 95% CI 3.28–306.20). Surprisingly, focus of the study, country of the first author and/or endorsement of the study by a trial group were not associated with COI statements.Conclusion : Our study suggests COI reporting to have been unintuitive to most investigators and unreliable before ICMJE statements, and that strong incentives are needed to implement adequate reporting of COI

    Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial-Protocol and statistical analysis plan

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    INTRODUCTION Severe acute respiratory syndrome coronavirus-2 has caused a pandemic of coronavirus disease (COVID-19) with many patients developing hypoxic respiratory failure. Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations. However, corticosteroids have undesirable effects, including longer time to viral clearance. Clinical equipoise on the use of corticosteroids for COVID-19 exists. METHODS The COVID STEROID trial is an international, randomised, stratified, blinded clinical trial. We will allocate 1000 adult patients with COVID-19 receiving ≥10 L/min of oxygen or on mechanical ventilation to intravenous hydrocortisone 200 mg daily vs placebo (0.9% saline) for 7 days. The primary outcome is days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, day 90, and 1 year; and health-related quality of life at 1 year. We will conduct the statistical analyses according to this protocol, including interim analyses for every 250 patients followed for 28 days. The primary outcome will be compared using the Kryger Jensen and Lange test in the intention to treat population and reported as differences in means and medians with 95% confidence intervals. DISCUSSION The COVID STEROID trial will provide important evidence to guide the use of corticosteroids in COVID-19 and severe hypoxia
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