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

Olliaro, P. and Grogl, M. and Boni, M. and Carvalho, E. M. and Chebli, H. and Cisse, M. and Diro, E. and Fernandes Cota, G. and Erber, A. C. and Gadisa, E. and Handjani, F. and Khamesipour, A. and Llanos-Cuentas, A. and López Carvajal, L. and Grout, L. and Lmimouni, B. E. and Mokni, M. and Nahzat, M. S. and Ben Salah, A. and Ozbel, Y. and Pascale, J. M. and Rizzo Molina, N. and Rode, J. and Romero, G. and Ruiz-Postigo, J. A. and Gore Saravia, N. and Soto, J. and Uzun, S. and Mashayekhi, V. and Vélez, I. D. and Vogt, F. and Zerpa, O. and Arana, B. (2018) Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation. PLoS Neglected Tropical Diseases, 12 (1).

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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.

Item Type: Article
Additional Information: Cited By :10 Export Date: 16 February 2020 Correspondence Address: Olliaro, P.; Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization (WHO)Switzerland; email: olliarop@who.int
Uncontrolled Keywords: amphotericin B deoxycholate amphotericin B lipid complex antiparasitic agent miltefosine pentamidine antiprotozoal agent Article clinical outcome clinical trial (topic) cost effectiveness analysis data analysis efficacy parameters follow up gender good clinical practice head flattening hematology human kidney function Leishmania Leishmania braziliensis Leishmania guyanensis Leishmania mexicana Leishmania panamensis Leishmania peruviana liver function lymphangitis methodology nonhuman parasite identification polymerase chain reaction skin leishmaniasis skin nodule skin redness skin ulcer treatment failure standards treatment outcome Antiprotozoal Agents Clinical Trials as Topic Humans Leishmaniasis, Cutaneous
Subjects: WC Communicable Diseases
WR Dermatology
QX Parasitology
Divisions: Mashhad University of Medical Sciences
Depositing User: lib2 lib2 lib2
Date Deposited: 07 May 2020 09:21
Last Modified: 07 May 2020 09:21
URI: http://eprints.mums.ac.ir/id/eprint/17457

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