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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01953744

Enrollment

Registered

2013-10-01

Start date

2014-02-28

Completion date

2015-11-30

Last updated

2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Leishmaniasis

Keywords

Fluconazole; Meglumine antimoniate;L.Braziliensis;, L.Guyanensis

Brief summary

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.

Interventions

DRUGFluconazole

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

DRUGMeglumine 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Cure rate or complete cicatrization of the ulcer.	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.

Secondary

Measure	Time frame	Description
Initial cure rate or complete cicatrization of the ulcer	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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026