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

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dc.contributor.author Olliaro, Piero
dc.contributor.author Grogl, Max
dc.contributor.author Boni, Marina
dc.contributor.author Carvalho, Edgar M.
dc.contributor.author Chebli, Houda
dc.contributor.author Cisse, Mamoudou
dc.contributor.author Diro, Ermias
dc.contributor.author Cota, Gláucia Fernandes
dc.contributor.author Erber, Astrid C.
dc.contributor.author Gadisa, Endalamaw
dc.contributor.author Handjani, Farhad
dc.contributor.author Khamesipour, Ali
dc.contributor.author Llanos-Cuentas, Alejandro
dc.contributor.author Carvajal, Liliana López
dc.contributor.author Grout, Lise
dc.contributor.author Lmimouni, Badre Eddine
dc.contributor.author Mokni, Mourad
dc.contributor.author Nahzat, Mohammad Sami
dc.contributor.author Salah, Afif Ben
dc.contributor.author Ozbel, Yusuf
dc.contributor.author Pascale, Juan Miguel
dc.contributor.author Molina, Nidia Rizzo
dc.contributor.author Rode, Joelle
dc.contributor.author Romero, Gustavo
dc.contributor.author Ruiz-Postigo, José Antonio
dc.contributor.author Saravia, Nancy Gore
dc.contributor.author Soto, Jaime
dc.contributor.author Uzun, Soner
dc.contributor.author Mashayekhi, Vahid
dc.contributor.author Vélez, Ivan Dario
dc.contributor.author Vogt, Florian
dc.contributor.author Zerpa, Olga
dc.contributor.author Arana, Byron
dc.date.accessioned 2018-06-18T15:26:49Z
dc.date.available 2018-06-18T15:26:49Z
dc.date.issued 2018
dc.identifier.uri https://hdl.handle.net/20.500.12866/3665
dc.description.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. en_US
dc.language.iso eng
dc.publisher PLoS
dc.relation.ispartof urn:issn:1935-2735
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject UNAVAILABLE en_US
dc.title Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1371/journal.pntd.0006141
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.00 es_PE
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.03.06

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