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

Piero Olliaro 1, 2, * Max Grogl 3 Marina Boni 4 Edgar Carvalho 5 Houda Chebli 6 Mamoudou Cissé 7 Ermias Diro 8 Gláucia Fernandes Cota 9 Astrid Erber 10 Endalamaw Gadisa 11 Farhad Handjani 12 Ali Khamesipour 13 Alejandro Llanos-Cuentas 14 Liliana López Carvajal 15 Lise Grout 16 Badre Eddine Lmimouni 17 Mourad Mokni 18 Mohammad Sami Nahzat 19 Afif Ben Salah 20 Yusuf Ozbel 21 Juan Miguel Pascale 22 Nidia Rizzo Molina 23 Joelle Rode 4 Gustavo Romero 24 José Antonio Ruiz-Postigo 16 Nancy Gore Saravia 25 Jaime Soto 26 Soner Uzun 27 Vahid Mashayekhi 28 Ivan Dario Vélez 15 Florian Vogt 29 Olga Zerpa 30 Byron Arana 31
* Corresponding author
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.
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Piero Olliaro, Max Grogl, Marina Boni, Edgar Carvalho, Houda Chebli, et al.. Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation. PLoS Neglected Tropical Diseases, Public Library of Science, 2018, 12 (1), pp.e0006141. ⟨10.1371/journal.pntd.0006141⟩. ⟨pasteur-01994628⟩

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