Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation

Piero Olliaro, Max Grogl, Marina Boni, Edgar M. Carvalho, Houda Chebli, Mamoudou Cisse, Ermias Diro, Glaucia Fernandes Cota, Astrid C. Erber, Endalamaw Gadisa, Farhad Handjani, Ali Khamesipour, Alejandro Llanos-Cuentas, Liliana Lopez Carvajal, Lise Grout, Badre Eddine Lmimouni, Mourad Mokni, Mohammad Sami Nahzat, Afif Ben Salah, Yusuf OzbelJuan Miguel Pascale, Nidia Rizzo Molina, Joelle Rode, Gustavo Romero, Jose Antonio Ruiz-Postigo, Nancy Gore Saravia, Jaime Soto, Soner Uzun, Vahid Mashayekhi, Ivan Dario Velez, Florian Vogt, Olga Zerpa, Byron Arana

Research output: Contribution to journalA1: Web of Science-article

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Abstract

Introduction

Progress with the treatment of cutaneous leishmaniasis (CL) has been hampered by inconsistent methodologies used to assess treatment effects. A sizable number of trials conducted over the years has generated only weak evidence backing current treatment recommendations, as shown by systematic reviews on old-world and new-world CL (OWCL and NWCL).

Materials and methods

Using a previously published guidance paper on CL treatment trial methodology as the reference, consensus was sought on key parameters including core eligibility and outcome measures, among OWCL (7 countries, 10 trial sites) and NWCL (7 countries, 11 trial sites) during two separate meetings.

Results

Findings and level of consensus within and between OWCL and NWCL sites are presented and discussed. In addition, CL trial site characteristics and capacities are summarized.

Conclusions

The consensus reached allows standardization of future clinical research across OWCL and NWCL sites. We encourage CL researchers to adopt and adapt as required the proposed parameters and outcomes in their future trials and provide feedback on their experience. The expertise afforded between the two sets of clinical sites provides the basis for a powerful consortium with potential for extensive, standardized assessment of interventions for CL and faster approval of candidate treatments.

Original languageEnglish
Article number0006141
JournalPLoS Neglected Tropical Diseases
Volume12
Number of pages12
ISSN1935-2735
DOIs
Publication statusPublished - 2018

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