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Title: Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation
Authors: Olliaro, Piero
Grogl, Max
Boni, Marina
Carvalho Filho, Edgar Marcelino
Chebli, Houda
Cisse, Mamoudou
Diro, Ermias
Cota, Gláucia Fernandes
Erber, Astrid C
Gadisa, Endalamaw
Handjani, Farhad
Khamesipour, Ali
Cuentas, Alejandro Llanos
Carvajal, Liliana López
Grout, Lise
Lmimouni, Badre Eddine
Mokni, Mourad
Nahzat, Mohammad Sami
Ben Salah, Afif
Ozbel, Yusuf
Pascale, Juan Miguel
Molina, Nidia Rizzo
Rode, Joelle
Romero, Gustavo
Postigo, José Antonio Ruiz
Saravia, Nancy Gore
Soto, Jaime
Uzun, Soner
Mashayekhi, Vahid
Vélez, Ivan Dario
Vogt, Florian
Zerpa, Olga
Arana, Byron
Affilliation: Múltipla – ver em Notas
Abstract: 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.
Keywords: Cutaneous leishmaniasis
Clinical trial
Neglected disease
keywords: Leishmaniose cutânea
Ensaios clinicos
Doença negligenciada
Issue Date: 2018
Publisher: Public Library of Science
Citation: OLLIARO, P. et al. Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation. PLoS Neglected Tropical Diseases, v. 12, p. e0006141, 2018.
Description: Carvalho Filho, Edgar Marcelino de. Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil. 1 Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization (WHO), Geneva, Switzerland, 2 Centre for Tropical Medicine and Vaccinology, Nuffield Department of Medicine, University of Oxford, Churchill Hospital, Oxford, United Kingdom, 3 U.S. Naval Medical Unit No.6 Peru, Lima, Peru, 4 Drugs for Neglected Diseases initiative (DNDi) Latin America, Rio de Janeiro, Brazil, 5 FundacËão Oswaldo Cruz (Fiocruz), Salvador Bahia, Brazil, 6 Direction de l'E pideÂmiologie et de Lutte contre les Maladies, Division des Maladies Transmissibles, Service des Maladies Parasitaires, Rabat, Morocco, 7 Universite Polytechnique de Bobo-Dioulasso, Bobo-Dioulasso, Burkina Faso, 8 Department of Internal Medicine, University of Gondar, Ethiopia, 9 Centro de Pesquisas Rene Rachou - FundacËão Oswaldo Cruz ± Minas, Minas Gerais, Brazil, 10 Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom, 11 Armauer Hansen Research Institute (AHRI), Addis Ababa, Ethiopia, 12 Molecular Dermatology Research Center, Faghihi Hospital, Shiraz University of Medical Sciences, Shiraz, Iran, 13 Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran, 14 Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru, 15 Programa de Estudio y Control de Enfermedades Tropicales (PECET), Universidad de Antioquia, Medellin, Colombia, 16 Neglected Tropical Diseases, World Health Organization, Geneva, Switzerland, 17 School of Medicine and Pharmacy, University Mohammed the fifth, Rabat, Morocco, 18 Dermatology Department, La Rabta Hospital, Tunis, Tunisia, 19 National Malaria & Leishmaniasis Control Program (NMLCP), Kabul, Afghanistan, 20 Service d'eÂpideÂmiologie meÂdicale, Institut Pasteur de Tunis, Tunis, Tunisia, 21 Department of Parasitology, Faculty of Medicine, Ege University, Izmir, Turkey, 22 Instituto Conmemorativo Gorgas de Estudios de la Salud, Panama , RepuÂblica de Panama , 23 Center for Health Studies, Universidad del Valle de Guatemala, Guatemala City, Guatemala, 24 NuÂcleo de Medicina Tropical, Universidade de BrasõÂlia, Campus Universita rio Darcy Ribeiro, BrasõÂlia, Brazil, 25 Centro Internacional de Entrenamiento e Investigaciones MeÂdicas (CIDEIM), Cali, Colombia, 26 FundacioÂn Nacional de DermatologõÂa (FUNDERMA), Santa Cruz de la Sierra, Santa Cruz, Bolivia, 27 Department of Dermatology, Faculty of Medicine, Akdeniz University, Antalya, Turkey, 28 Department of Dermatology, Emam Reza Hospital, Mashhad, Iran, 29 Unit of HIV and Neglected Tropical Diseases, Institute of Tropical Medicine Antwerp, Antwerp, Belgium, 30 Instituto Medico la Floresta, Caracas, Venezuela, 31 Drugs for Neglected Diseases initiative (DNDi), Geneva, Switzerland
DOI: 10.1371/journal.pntd.0006141
ISSN: 1935-2727
Copyright: open access
Appears in Collections:BA - IGM - Artigos de Periódicos

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