%0 Journal Article %T Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation %+ WHO-TDR Suisse %+ Nuffield Department of Clinical Medicine [Oxford] %+ U.S. Naval Medical Research Unit No. 6 (NAMRU-6) %+ Drugs for Neglected Diseases initiative Latin America (DNDi) %+ Fundação Oswaldo Cruz / Oswaldo Cruz Foundation (FIOCRUZ) %+ Direction de l’Epidémiologie et de Lutte contre les Maladies (DELM) %+ Université Polytechnique de Bobo-Dioulasso (UPB) %+ University of Gondar - Université de Gondar %+ Fiocruz Minas - René Rachou Research Center / Instituto René Rachou [Belo Horizonte, Brésil] %+ Nuffield Department of Medicine [Oxford, UK] (Big Data Institute) %+ Armauer Hansen Research Institute (AHRI) %+ Shiraz University (Shiraz University ) %+ Tehran University of Medical Sciences (TUMS) %+ Instituto de Medicina Tropical "Alexander von Humboldt" (IMT AvH) %+ Universidad de Antioquia = University of Antioquia [Medellín, Colombia] %+ World Health Organisation (WHO) %+ Université Mohammed V de Rabat [Agdal] (UM5) %+ Hôpital La Rabta [Tunis] %+ National Malaria & Leishmaniasis Control Program [Kabul] (NMLCP) %+ Laboratoire d'Epidémiologie Médicale, Institut Pasteur de Tunis %+ Ege university %+ Instituto Conmemorativo Gorgas de Estudios de la Salud [Panamá] %+ Universidad del Valle de Guatemala %+ Universidade de Brasilia [Brasília] (UnB) %+ Centro Internacional de Entrenamiento e Investigaciones Medicas (CIDEIM) %+ Fundación Nacional de Dermatología [Santa Cruz] (FUNDERMA) %+ Akdeniz University %+ Imam Reza Hospital [Iran] %+ Institute of Tropical Medicine [Antwerp] (ITM) %+ Instituto Medico la Floresta [Caracas] %+ Drugs for Neglected Diseases Initiative %A Olliaro, Piero %A Grogl, Max %A Boni, Marina %A Carvalho, Edgar, M %A Chebli, Houda %A Cissé, Mamoudou %A Diro, Ermias %A Fernandes Cota, Gláucia %A Erber, Astrid, C %A Gadisa, Endalamaw %A Handjani, Farhad %A Khamesipour, Ali %A Llanos-Cuentas, Alejandro %A López Carvajal, Liliana %A Grout, Lise %A Lmimouni, Badre Eddine %A Mokni, Mourad %A Nahzat, Mohammad Sami %A Ben Salah, Afif %A Ozbel, Yusuf %A Pascale, Juan Miguel %A Rizzo Molina, Nidia %A Rode, Joelle %A Romero, Gustavo %A Ruiz-Postigo, José Antonio %A Gore Saravia, Nancy %A Soto, Jaime %A Uzun, Soner %A Mashayekhi, Vahid %A Vélez, Ivan Dario %A Vogt, Florian %A Zerpa, Olga %A Arana, Byron %< avec comité de lecture %@ 1935-2727 %J PLoS Neglected Tropical Diseases %I Public Library of Science %V 12 %N 1 %P e0006141 %8 2018-01-12 %D 2018 %R 10.1371/journal.pntd.0006141 %M 29329311 %Z Life Sciences [q-bio] %Z Life Sciences [q-bio]/Microbiology and ParasitologyJournal articles %X 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. %G English %2 https://riip.hal.science/pasteur-01994628/document %2 https://riip.hal.science/pasteur-01994628/file/Harmonized%20clinical.pdf %L pasteur-01994628 %U https://riip.hal.science/pasteur-01994628 %~ RIIP %~ RIIP_TUNIS