Clinical Trial to Assess Efficacy and Safety of Orally Administered Miltefosine in Brazilian Patients With Cutaneous Leishmaniasis Compared to the Standard Care as Active Control
Overview
- Phase
- Phase 2
- Intervention
- Miltefosine.
- Conditions
- Treatment of Cutaneous Leishmaniasis in Brazil.
- Sponsor
- Hospital Universitário Professor Edgard Santos
- Enrollment
- 180
- Locations
- 2
- Primary Endpoint
- Cure rate or complete cicatrization of the ulcer.
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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®).
Investigators
Eligibility Criteria
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
Arms & Interventions
1.1
Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Miltefosine.
Intervention: Miltefosine.
1.2
Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Meglumine antimoniate (standard treatment).
Intervention: Meglumine antimoniate.
2.1
Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Miltefosine.
Intervention: Miltefosine.
2.2
Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Meglumine antimoniate (standard treatment).
Intervention: Meglumine antimoniate.
Outcomes
Primary Outcomes
Cure rate or complete cicatrization of the ulcer.
Time Frame: 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 Outcomes
- Inicial cure rate or complete cicatrization of the ulcer.(2 months after treatment.)