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

dc.creatorOlliaro, Piero
dc.creatorGrogl, Max
dc.creatorBoni, Marina
dc.creatorCarvalho Filho, Edgar Marcelino
dc.creatorChebli, Houda
dc.creatorCisse, Mamoudou
dc.creatorDiro, Ermias
dc.creatorCota, Gláucia Fernandes
dc.creatorErber, Astrid C
dc.creatorGadisa, Endalamaw
dc.creatorHandjani, Farhad
dc.creatorKhamesipour, Ali
dc.creatorCuentas, Alejandro Llanos
dc.creatorCarvajal, Liliana López
dc.creatorGrout, Lise
dc.creatorLmimouni, Badre Eddine
dc.creatorMokni, Mourad
dc.creatorNahzat, Mohammad Sami
dc.creatorBen Salah, Afif
dc.creatorOzbel, Yusuf
dc.creatorPascale, Juan Miguel
dc.creatorMolina, Nidia Rizzo
dc.creatorRode, Joelle
dc.creatorRomero, Gustavo
dc.creatorPostigo, José Antonio Ruiz
dc.creatorSaravia, Nancy Gore
dc.creatorSoto, Jaime
dc.creatorUzun, Soner
dc.creatorMashayekhi, Vahid
dc.creatorVélez, Ivan Dario
dc.creatorVogt, Florian
dc.creatorZerpa, Olga
dc.creatorArana, Byron
dc.date2018-04-16T12:39:58Z
dc.date2018-04-16T12:39:58Z
dc.date2018
dc.date.accessioned2023-09-26T22:27:52Z
dc.date.available2023-09-26T22:27:52Z
dc.identifierOLLIARO, 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.
dc.identifier1935-2727
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/25847
dc.identifier10.1371/journal.pntd.0006141
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8879565
dc.descriptionCarvalho 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
dc.descriptionWorld Health Organization (WHO)
dc.descriptionProgress 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.
dc.formatapplication/pdf
dc.languageeng
dc.publisherPublic Library of Science
dc.rightsopen access
dc.subjectLeishmaniose cutânea
dc.subjectTratamento
dc.subjectEnsaios clinicos
dc.subjectDoença negligenciada
dc.subjectMetodologias
dc.subjectLeishmaniose
dc.subjectCutaneous leishmaniasis
dc.subjectTreatment
dc.subjectClinical trial
dc.subjectNeglected disease
dc.subjectMethodologies
dc.subjectLeishmania
dc.titleHarmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation
dc.typeArticle


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