High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus

Phase 3

Terminated

• Conditions: Cutaneous Leishmaniasis
• Interventions: Drug: Fluconazole; Drug: Meglumine Antimoniate

• Registration Number: NCT01953744
• Lead Sponsor: Hospital Universitário Professor Edgard Santos

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-25
• Study First Submitted QC: 2013-09-25
• Study First Posted: 2013-10-01
• Study Start: 2014-02
• Primary Completion: 2015-04
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluconazole	Fluconazole	Fluconazole will be administered by oral route at 6-8mg/kg/day during 28 days.
Meglumine Antimoniate	Meglumine Antimoniate	Meglumine Antimoniate will be administered by intravenous route at 20mg/kg/day during 20 days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Posto de Saúde de Corte de Pedra; 🇧🇷 Presidente Tancredo Neves, Bahia, Brazil