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

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

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

Detalhes bibliográficos
Autor(a) principal:	Olliaro, Piero
Data de Publicação:	2018
Outros Autores:	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
Tipo de documento:	Artigo
Idioma:	eng
Título da fonte:	Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo:	https://www.arca.fiocruz.br/handle/icict/25847
Resumo:	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'EÂ pideÂmiologie et de Lutte contre les Maladies, Division des Maladies Transmissibles, Service des Maladies Parasitaires, Rabat, Morocco, 7 UniversiteÂ Polytechnique de Bobo-Dioulasso, Bobo-Dioulasso, Burkina Faso, 8 Department of Internal Medicine, University of Gondar, Ethiopia, 9 Centro de Pesquisas ReneÂ 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, PanamaÂ , RepuÂblica de PanamaÂ , 23 Center for Health Studies, Universidad del Valle de Guatemala, Guatemala City, Guatemala, 24 NuÂcleo de Medicina Tropical, Universidade de BrasõÂlia, Campus UniversitaÂ 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

Metadados do item

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oai_identifier_str	oai:www.arca.fiocruz.br:icict/25847
network_acronym_str	CRUZ
network_name_str	Repositório Institucional da FIOCRUZ (ARCA)
repository_id_str	2135
spelling	Olliaro, PieroGrogl, MaxBoni, MarinaCarvalho Filho, Edgar MarcelinoChebli, HoudaCisse, MamoudouDiro, ErmiasCota, Gláucia FernandesErber, Astrid CGadisa, EndalamawHandjani, FarhadKhamesipour, AliCuentas, Alejandro LlanosCarvajal, Liliana LópezGrout, LiseLmimouni, Badre EddineMokni, MouradNahzat, Mohammad SamiBen Salah, AfifOzbel, YusufPascale, Juan MiguelMolina, Nidia RizzoRode, JoelleRomero, GustavoPostigo, José Antonio RuizSaravia, Nancy GoreSoto, JaimeUzun, SonerMashayekhi, VahidVélez, Ivan DarioVogt, FlorianZerpa, OlgaArana, Byron2018-04-16T12:39:58Z2018-04-16T12:39:58Z2018OLLIARO, 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, 2018.1935-2727https://www.arca.fiocruz.br/handle/icict/2584710.1371/journal.pntd.0006141Carvalho 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'EÂ pideÂmiologie et de Lutte contre les Maladies, Division des Maladies Transmissibles, Service des Maladies Parasitaires, Rabat, Morocco, 7 UniversiteÂ Polytechnique de Bobo-Dioulasso, Bobo-Dioulasso, Burkina Faso, 8 Department of Internal Medicine, University of Gondar, Ethiopia, 9 Centro de Pesquisas ReneÂ 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, PanamaÂ , RepuÂblica de PanamaÂ , 23 Center for Health Studies, Universidad del Valle de Guatemala, Guatemala City, Guatemala, 24 NuÂcleo de Medicina Tropical, Universidade de BrasõÂlia, Campus UniversitaÂ 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, SwitzerlandWorld Health Organization (WHO)Múltipla – ver em NotasProgress 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.engPublic Library of ScienceLeishmaniose cutâneaTratamentoEnsaios clinicosDoença negligenciadaMetodologiasLeishmanioseCutaneous leishmaniasisTreatmentClinical trialNeglected diseaseMethodologiesLeishmaniaHarmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluationinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/25847/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALOlliaro P Harmonized clinical trial 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dc.title.pt_BR.fl_str_mv	Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation
title	Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation
spellingShingle	Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation Olliaro, Piero Leishmaniose cutânea Tratamento Ensaios clinicos Doença negligenciada Metodologias Leishmaniose Cutaneous leishmaniasis Treatment Clinical trial Neglected disease Methodologies Leishmania
title_short	Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation
title_full	Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation
title_fullStr	Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation
title_full_unstemmed	Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation
title_sort	Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation
author	Olliaro, Piero
author_facet	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
author_role	author
author2	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
author2_role	author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author
dc.contributor.author.fl_str_mv	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
dc.subject.other.pt_BR.fl_str_mv	Leishmaniose cutânea Tratamento Ensaios clinicos Doença negligenciada Metodologias Leishmaniose
topic	Leishmaniose cutânea Tratamento Ensaios clinicos Doença negligenciada Metodologias Leishmaniose Cutaneous leishmaniasis Treatment Clinical trial Neglected disease Methodologies Leishmania
dc.subject.en.pt_BR.fl_str_mv	Cutaneous leishmaniasis Treatment Clinical trial Neglected disease Methodologies Leishmania
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'EÂ pideÂmiologie et de Lutte contre les Maladies, Division des Maladies Transmissibles, Service des Maladies Parasitaires, Rabat, Morocco, 7 UniversiteÂ Polytechnique de Bobo-Dioulasso, Bobo-Dioulasso, Burkina Faso, 8 Department of Internal Medicine, University of Gondar, Ethiopia, 9 Centro de Pesquisas ReneÂ 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, PanamaÂ , RepuÂblica de PanamaÂ , 23 Center for Health Studies, Universidad del Valle de Guatemala, Guatemala City, Guatemala, 24 NuÂcleo de Medicina Tropical, Universidade de BrasõÂlia, Campus UniversitaÂ 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
publishDate	2018
dc.date.accessioned.fl_str_mv	2018-04-16T12:39:58Z
dc.date.available.fl_str_mv	2018-04-16T12:39:58Z
dc.date.issued.fl_str_mv	2018
dc.type.status.fl_str_mv	info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv	info:eu-repo/semantics/article
format	article
status_str	publishedVersion
dc.identifier.citation.fl_str_mv	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.
dc.identifier.uri.fl_str_mv	https://www.arca.fiocruz.br/handle/icict/25847
dc.identifier.issn.pt_BR.fl_str_mv	1935-2727
dc.identifier.doi.none.fl_str_mv	10.1371/journal.pntd.0006141
identifier_str_mv	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. 1935-2727 10.1371/journal.pntd.0006141
url	https://www.arca.fiocruz.br/handle/icict/25847
dc.language.iso.fl_str_mv	eng
language	eng
dc.rights.driver.fl_str_mv	info:eu-repo/semantics/openAccess
eu_rights_str_mv	openAccess
dc.publisher.none.fl_str_mv	Public Library of Science
publisher.none.fl_str_mv	Public Library of Science
dc.source.none.fl_str_mv	reponame:Repositório Institucional da FIOCRUZ (ARCA) instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ
instname_str	Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str	FIOCRUZ
institution	FIOCRUZ
reponame_str	Repositório Institucional da FIOCRUZ (ARCA)
collection	Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv	https://www.arca.fiocruz.br/bitstream/icict/25847/1/license.txt https://www.arca.fiocruz.br/bitstream/icict/25847/2/Olliaro%20P%20Harmonized%20clinical%20trial%20methodologies....pdf https://www.arca.fiocruz.br/bitstream/icict/25847/3/Olliaro%20P%20Harmonized%20clinical%20trial%20methodologies....pdf.txt
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bitstream.checksumAlgorithm.fl_str_mv	MD5 MD5 MD5
repository.name.fl_str_mv	Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv	repositorio.arca@fiocruz.br
_version_	1813009130032463872

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

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