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HARMONIZED CLINICAL TRIAL METHODOLOGIES FOR LOCALIZED CUTANEOUS LEISHMANIASIS AND POTENTIAL FOR EXTENSIVE NETWORK WITH CAPACITIES FOR CLINICAL EVALUATION
Tratamento
Ensaios clinicos
Doença negligenciada
Metodologias
Leishmaniose
Treatment
Clinical trial
Neglected disease
Methodologies
Leishmania
Autor
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
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
Afiliación
Múltipla – ver em Notas
Resumen en ingles
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.
Palabras clave en portugues
Leishmaniose cutâneaTratamento
Ensaios clinicos
Doença negligenciada
Metodologias
Leishmaniose
Palabras clave en ingles
Cutaneous leishmaniasisTreatment
Clinical trial
Neglected disease
Methodologies
Leishmania
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