Treatment of Cutaneous Leishmaniasis in Brazil.
Conditions
Keywords
Cutaneous leishmaniasis, Miltefosine, Meglumine antimoniate, L. braziliensis, L. guyanensis
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®).
Interventions
DRUGMiltefosine.
Miltefosine: Capsules containing 10 mg or 50 mg miltefosine; administered orally for 28 days at dosage of 2.5 mg/kg body weight per day.
Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Ministerio de Ciencia e Innovación, Spain
Ministry of Health, Brazil
AEterna Zentaris
Hospital Universitário Professor Edgard Santos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Outcome results
None listed