Treatment of Cutaneous Leishmaniasis in Brazil. Clinical Trial
Official title:
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
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®).
| Status | Completed |
| Enrollment | 180 |
| Est. completion date | July 2009 |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Fundação de Medicina Tropical do Amazonas | Manaus | Amazonas |
| Brazil | Posto de Saúde de Corte de Pedra | Tancredo Neto | Bahia |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Universitário Professor Edgard Santos | AEterna Zentaris, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Ministério da Saúde, Ministerio de Ciencia e Innovación, Spain |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cure rate or complete cicatrization of the ulcer. | 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. |
6 months after treatment. | Yes |
| Secondary | Inicial cure rate or complete cicatrization of the ulcer. | 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. |
2 months after treatment. | Yes |