High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus
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|ClinicalTrials.gov Identifier: NCT01953744|
Recruitment Status : Terminated (Low cure rate in the study (fluconazole) group)
First Posted : October 1, 2013
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous Leishmaniasis||Drug: Fluconazole Drug: Meglumine Antimoniate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Phase 3 Randomized Trial Comparing Fluconazole to Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Caused by L. Braziliensis and L. Guyanensis|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||November 2015|
Fluconazole will be administered by oral route at 6-8mg/kg/day during 28 days.
Fluconazole is presented in 150mg capsules and will be administered by oral route at a dosage of 6-8mg/kg/day during 28 days.
Active Comparator: Meglumine Antimoniate
Meglumine Antimoniate will be administered by intravenous route at 20mg/kg/day during 20 days.
Drug: Meglumine Antimoniate
Meglumine Antimoniate will be administered as the standard treatment for cutaneous leishmaniasis by intravenous route at a dosage of 20mg/kg/day, during 20 days.
Other Name: Glucantime
- Cure rate or complete cicatrization of the ulcer. [ Time Frame: 6 months ]All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.
- Initial cure rate or complete cicatrization of the ulcer [ Time Frame: 2 months ]All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953744
|Posto de Saúde de Corte de Pedra|
|Presidente Tancredo Neves, Bahia, Brazil, 45416000|
|Principal Investigator:||Paulo Roberto Lima Machado, PhD||University of Bahia|