High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus

Cutaneous Leishmaniasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01953744
• Other study ID #: FlucoLBrBaMa
• Status: Terminated
• Phase: Phase 3
• First received: September 25, 2013
• Last updated: December 1, 2015
• Start date: February 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Hospital Universitário Professor Edgard Santos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: November 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Posto de Saúde de Corte de Pedra	Presidente Tancredo Neves	Bahia

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitário Professor Edgard Santos	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate or complete cicatrization of the ulcer.	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.	6 months	No
Secondary	Initial cure rate or complete cicatrization of the ulcer	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.	2 months	No