Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

Phase 2

Completed

• Conditions: Treatment of Cutaneous Leishmaniasis in Brazil.
• Interventions: Drug: Miltefosine.; Drug: Meglumine antimoniate.

• Registration Number: NCT00600548
• Lead Sponsor: Hospital Universitário Professor Edgard Santos

Brief Summary

The hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine in Brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous standard treatment (meglumine antimoniate - Glucantime®).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-01-02
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-25
• Primary Completion: 2009-03
• Study Completion: 2009-07
• Status Verified: 2010-03
• Last Update Submitted: 2010-04-14
• Last Update Posted: 2010-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

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

Exclusion Criteria

Safety concerns:

• Thrombocyte count <30 x 109/l
• Leukocyte count <1 x 109/l
• Hemoglobin <5 g/100 ml
• ASAT, ALAT, AP >3 times upper limit of normal range
• Bilirubin >2 times upper limit of normal range
• Serum creatinine or BUN >1.5 times upper limit of normal range
• 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/smear)or negative Montenegro test
• Any history of prior anti-leishmania therapy
• Any condition which compromises ability to comply with the study procedures
• Concomitant serious infection other than cutaneous

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
1.1	Miltefosine.	Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Miltefosine.
1.2	Meglumine antimoniate.	Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Meglumine antimoniate (standard treatment).
2.1	Miltefosine.	Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Miltefosine.
2.2	Meglumine antimoniate.	Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Meglumine antimoniate (standard treatment).

Primary Outcome Measures

Name	Time	Method
Cure rate or complete cicatrization of the ulcer.	6 months after treatment.	Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements.; 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
Inicial cure rate or complete cicatrization of the ulcer.	2 months after treatment.	Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements.; 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 (2)

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

Fundação de Medicina Tropical do Amazonas; 🇧🇷 Manaus, Amazonas, Brazil