Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil

Toledo, Antonio; Daher, André; Amaral, Thaís Alves; Carvalho, Sílvio Fernando Guimarães; Romero, Gustavo Adolfo Sierra; Rabello, Ana

doi:10.1590/0037-8682-0266-2014

Cited by 4 publications

(1 citation statement)

References 18 publications

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“…Sex was considered an inclusion criterion in 94.3% ( n = 100) of studies enrolling 11 081 patients; 87.7% ( n = 93) enrolled participants of both sexes , seven studies (6.6%) enrolled only men ; in five studies (4.7%), although sex was not specified in the inclusion criteria, inclusions can be derived from the results , and one study did not refer to the sex of the participants (Table ). For pregnancy and lactation, see Exclusion criteria below (Table ).…”

Section: Resultsmentioning

confidence: 99%

Eligibility criteria and outcome measures adopted in clinical trials of treatments of cutaneous leishmaniasis: systematic literature review covering the period 1991–2015

López-Carvajal

Vélez

Arbeláez

et al. 2018

Tropical Med Int Health

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Abstractobjective To document the sources of heterogeneity in outcomes and shortcomings in trial designs reported by previous systematic reviews.methods Systematic review of clinical trials of CL treatments published since 1991, to assess and compare eligibility criteria and outcome measures in trials (any type of treatment) of CL (any form) reported before and after the publication of the CONSORT statement.results We identified 106 eligible trials published between 1991 and 2015, 74% after the 2001 CONSORT statement; 58% (n = 63) were on Old-World CL and 37% (n = 40) in New-World CL; overall, 11 531 patients enrolled in 243 treatment groups on 30 different treatments. Both requirements and definitions for eligibility and outcome criteria varied. Compliance with CONSORT requirements increased for studies published after the 2010 update. As for entry criteria, 94% of studies had a requirement for sex (74% of those enrolling also women excluded those who were pregnant or lactating), 69% for age (variable age ranges), 99% parasitological confirmation, 43% prior duration of illness (14% excluded cases with previous episodes), 46% defined the number, 28% the size and 13% the type of lesions (27% with restrictions as to their anatomical location). Follow-up ranged 1-24 months, with 14% and 91% of studies, respectively, having defined initial and final cure.conclusions This review documents changes in reporting before and after the publication of the CONSORT statement. Lack of standardisation, compounded with the small number of trials relative to the magnitude of the disease in its multiple forms, and with the range of treatments tested explains why evidence to inform treatment guidelines is generally weak for CL. Adopting standardised methodologies will improve the quality and consistency of clinical trials, and ultimately yield better treatments for CL.

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Section: Resultsmentioning

confidence: 99%