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Harmonized Clinical Trial Methodologies for Localized Cutaneous Leishmaniasis and Potential for Extensive Network With Capacities for Clinical Evaluation Publisher Pubmed



Olliaro P1, 2 ; Grogl M3 ; Boni M4 ; Carvalho EM5 ; Chebli H6 ; Cisse M7 ; Diro E8 ; Fernandes Cota G9 ; Erber AC10 ; Gadisa E11 ; Handjani F12 ; Khamesipour A13 ; Llanoscuentas A14 ; Lopez Carvajal L15 Show All Authors
Authors
  1. Olliaro P1, 2
  2. Grogl M3
  3. Boni M4
  4. Carvalho EM5
  5. Chebli H6
  6. Cisse M7
  7. Diro E8
  8. Fernandes Cota G9
  9. Erber AC10
  10. Gadisa E11
  11. Handjani F12
  12. Khamesipour A13
  13. Llanoscuentas A14
  14. Lopez Carvajal L15
  15. Grout L16
  16. Lmimouni BE17
  17. Mokni M18
  18. Nahzat MS19
  19. Ben Salah A20
  20. Ozbel Y21
  21. Pascale JM22
  22. Rizzo Molina N23
  23. Rode J4
  24. Romero G24
  25. Ruizpostigo JA16
  26. Gore Saravia N25
  27. Soto J26
  28. Uzun S27
  29. Mashayekhi V28
  30. Velez ID15
  31. Vogt F29
  32. Zerpa O30
  33. Arana B31
Show Affiliations
Authors Affiliations
  1. 1. Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization (WHO), Geneva, Switzerland
  2. 2. Centre for Tropical Medicine and Vaccinology, Nuffield Department of Medicine, University of Oxford, Churchill Hospital, Oxford, United Kingdom
  3. 3. U.S. Naval Medical Unit No.6 Peru, Lima, Peru
  4. 4. Drugs for Neglected Diseases initiative (DNDi) Latin America, Rio de Janeiro, Brazil
  5. 5. Fundacao Oswaldo Cruz (Fiocruz), Salvador Bahia, Brazil
  6. 6. Direction de l’Epidemiologie et de Lutte contre les Maladies, Division des Maladies Transmissibles, Service des Maladies Parasitaires, Rabat, Morocco
  7. 7. Universite Polytechnique de Bobo-Dioulasso, Bobo-Dioulasso, Burkina Faso
  8. 8. Department of Internal Medicine, University of Gondar, Ethiopia
  9. 9. Centro de Pesquisas Rene Rachou - Fundacao Oswaldo Cruz – Minas, Minas Gerais, Brazil
  10. 10. Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom
  11. 11. Armauer Hansen Research Institute (AHRI), Addis Ababa, Ethiopia
  12. 12. Molecular Dermatology Research Center, Faghihi Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
  13. 13. Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran
  14. 14. Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru
  15. 15. Programa de Estudio y Control de Enfermedades Tropicales (PECET), Universidad de Antioquia, Medellin, Colombia
  16. 16. Neglected Tropical Diseases, World Health Organization, Geneva, Switzerland
  17. 17. School of Medicine and Pharmacy, University Mohammed the fifth, Rabat, Morocco
  18. 18. Dermatology Department, La Rabta Hospital, Tunis, Tunisia
  19. 19. National Malaria & Leishmaniasis Control Program (NMLCP), Kabul, Afghanistan
  20. 20. Service d'epidemiologie medicale, Institut Pasteur de Tunis, Tunis, Tunisia
  21. 21. Department of Parasitology, Faculty of Medicine, Ege University, Izmir, Turkey
  22. 22. Instituto Conmemorativo Gorgas de Estudios de la Salud, Panama, Panama
  23. 23. Center for Health Studies, Universidad del Valle de, Guatemala City, Guatemala
  24. 24. Nucleo de Medicina Tropical, Universidade de Brasilia, Campus Universitario Darcy Ribeiro, Brasilia, Brazil
  25. 25. Centro Internacional de Entrenamiento e Investigaciones Medicas (CIDEIM), Cali, Colombia
  26. 26. Fundacion Nacional de Dermatologia (FUNDERMA), Santa Cruz de la Sierra, Santa Cruz, Bolivia
  27. 27. Department of Dermatology, Faculty of Medicine, Akdeniz University, Antalya, Turkey
  28. 28. Department of Dermatology, Emam Reza Hospital, Mashhad, Iran
  29. 29. Unit of HIV and Neglected Tropical Diseases, Institute of Tropical Medicine Antwerp, Antwerp, Belgium
  30. 30. Instituto Medico la Floresta, Caracas, Venezuela
  31. 31. Drugs for Neglected Diseases initiative (DNDi), Geneva, Switzerland

Source: PLoS Neglected Tropical Diseases Published:2018


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. © 2018 Public Library of Science. All Rights Reserved.