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

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dc.creatorGlaucia Fernandes Cota
dc.creatorPiero Olliaro
dc.creatorMax Grogl
dc.creatorMarina Boni
dc.creatorEdgar M. Carvalho
dc.creatorHouda Chebli
dc.creatorMamoudou Cisse
dc.creatorErmias Diro
dc.creatorAstrid C. Erber
dc.creatorEndalamaw Gadisa
dc.creatorFarhad Handjani
dc.creatorAli Khamesipour
dc.creatorAlejandro Llanos-Cuentas
dc.creatorLiliana López Carvajal
dc.creatorLise Grout
dc.creatorBadre Eddine Lmimoun
dc.creatorMourad Mokn
dc.creatorMohammad Sami Nahzat
dc.creatorAfif Ben Salah
dc.creatorYusuf Ozbel
dc.creatorJuan Miguel Pascale
dc.creatorNidia Rizzo Molina
dc.creatorJoelle Rode
dc.creatorGustavo Romero
dc.creatorJosé Antonio Ruiz-Postigo
dc.creatorNancy Gore Saravia
dc.creatorJaime Soto
dc.creatorSoner Uzun
dc.creatorVahid Mashayekhi
dc.creatorIvan Dario Vélez
dc.creatorFlorian Vogt
dc.creatorOlga Zerpa
dc.creatorByron Arana
dc.date.accessioned2024-11-27T23:56:41Z
dc.date.accessioned2025-09-08T23:33:09Z
dc.date.available2024-11-27T23:56:41Z
dc.date.issued2018-01-12
dc.format.mimetypepdf
dc.identifier.doi10.1371/journal.pntd.0006141
dc.identifier.issn1935-2735
dc.identifier.urihttps://hdl.handle.net/1843/78338
dc.languageeng
dc.publisherUniversidade Federal de Minas Gerais
dc.relation.ispartofPlos Neglected Tropical Diseases
dc.rightsAcesso Aberto
dc.subjectLeishmaniose Cutânea
dc.subjectProcedimentos Clínicos
dc.subjectPacientes
dc.titleHarmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation
dc.typeArtigo de periódico
local.citation.epage12
local.citation.spage1
local.citation.volume12
local.description.resumoIntroduction: 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.
local.publisher.countryBrasil
local.publisher.departmentMEDICINA - FACULDADE DE MEDICINA
local.publisher.initialsUFMG
local.url.externahttps://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0006141

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