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Efficacy and safety of pre-exposure of antibiotic prophylaxis for leptospirosis: protocol of a systematic review and meta-analysis

Introduction: Leptospirosis is the most widespread zoonosis in the world. It represents a public health problem especially in tropical and subtropical regions, but it is also presents in temperate regions. Spirochetes from leptospira genus cause the disease, they affect humans as an intermediate host. About pre-exposure prophylaxis for people at risk, antibiotics such as doxycycline or azithromycin were used to prevent the development of leptospirosis and its related adverse outcomes. However, the evidence about the efficacy and safety of this intervention is limited. Objectives: To determine whether pre-exposure antibiotic administration prevents infection, hospitalization, or mortality from leptospirosis, without causing severe adverse effects. Methods: We propose to do a systematic review and meta-analysis. We will search in Pubmed (Medline), Embase.com, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, Web of Science, LILACS and ClinicalTrials.gov. Individual randomized controlled trials, non-randomized controlled trials, cohorts, and cases-control studies will be included according to the inclusion and exclusion criteria set. The flow chart for selecting studies to be included will be presented in accordance with the PRISMA guide. The methodological quality of the studies will be evaluated by duplicate. Subsequently, the qualitative analysis of the data will be carried out and the feasibility of a quantitative meta-analysis will be evaluated. Finally, a summary of findings table will be presented according to the feasibility of the meta-analysis. Results: The results will be published in a peer-reviewed journal. Conclusion: This systematic review will sum up-to-date evidence about the efficacy and safety of pre-exposure antibiotic prophylaxis for preventing laboratory-confirmed leptospirosis, hospitalization and mortality.