TY - JOUR
T1 - Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation
AU - Olliaro, Piero
AU - Grogl, Max
AU - Boni, Marina
AU - Carvalho, Edgar M.
AU - Chebli, Houda
AU - Cisse, Mamoudou
AU - Diro, Ermias
AU - Fernandes Cota, Gláucia
AU - Erber, Astrid C.
AU - Gadisa, Endalamaw
AU - Handjani, Farhad
AU - Khamesipour, Ali
AU - Llanos-Cuentas, Alejandro
AU - López Carvajal, Liliana
AU - Grout, Lise
AU - Lmimouni, Badre Eddine
AU - Mokni, Mourad
AU - Nahzat, Mohammad Sami
AU - Ben Salah, Afif
AU - Ozbel, Yusuf
AU - Pascale, Juan Miguel
AU - Rizzo Molina, Nidia
AU - Rode, Joelle
AU - Romero, Gustavo
AU - Ruiz-Postigo, José Antonio
AU - Gore Saravia, Nancy
AU - Soto, Jaime
AU - Uzun, Soner
AU - Mashayekhi, Vahid
AU - Vélez, Ivan Dario
AU - Vogt, Florian
AU - Zerpa, Olga
AU - Arana, Byron
N1 - Publisher Copyright:
© 2018 Public Library of Science. All Rights Reserved.
PY - 2018/1
Y1 - 2018/1
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/85041698499
U2 - 10.1371/journal.pntd.0006141
DO - 10.1371/journal.pntd.0006141
M3 - Artículo
C2 - 29329311
AN - SCOPUS:85041698499
SN - 1935-2727
VL - 12
JO - PLoS Neglected Tropical Diseases
JF - PLoS Neglected Tropical Diseases
IS - 1
M1 - e0006141
ER -