Trial | NCT01953744  Report issue

Title

High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus
Phase 3 Randomized Trial Comparing Fluconazole to Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Caused by L. Braziliensis and L. Guyanensis

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    53
The purpose of this study is to evaluate the therapeutic response to fluconazole in patients with cutaneous leishmaniasis caused by and L.(V.)guyanensis and L.(V.) braziliensis.
Study Started
Feb 28
2014
Primary Completion
Apr 30
2015
Study Completion
Nov 30
2015
Last Update
Dec 02
2015
Estimate

Drug Fluconazole

Fluconazole is presented in 150mg capsules and will be administered by oral route at a dosage of 6-8mg/kg/day during 28 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 names: Glucantime

Fluconazole Experimental

Fluconazole will be administered by oral route at 6-8mg/kg/day during 28 days.

Meglumine Antimoniate Active Comparator

Meglumine Antimoniate will be administered by intravenous route at 20mg/kg/day during 20 days.

Criteria 

Inclusion Criteria:

Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
Number of lesions: 1 to 3 ulcerative lesions.
Lesion´s diameter: 1 to 5 cm.
Disease duration: up to three months.

Exclusion Criteria:

Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
Immunodeficiency or antibody to HIV
Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases

Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months

Lack of suitability for the trial:
Negative parasitology (aspirate/biopsy/PCR)or negative Montenegro test
Any history of prior anti-leishmania therapy

Any condition which compromises ability to comply with the study procedures

Administrative reasons:
Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
Anticipated non-availability for study visits/procedures
No Results Posted