Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

Hospital Universitário Professor Edgard Santos

Status and phase: Completed; Phase 2

Conditions: Treatment of Cutaneous Leishmaniasis in Brazil.

Treatments: Drug: Miltefosine.; Drug: Meglumine antimoniate.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00600548

D-18506

410559/2006-7

Details and patient eligibility

About

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®).

Enrollment: 180 patients

Sex: All

Ages: 2 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 4 patient groups

1.1

Experimental group

Description:

Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Miltefosine.

Treatment:

Drug: Miltefosine.

Drug: Miltefosine.

1.2

Active Comparator group

Description:

Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Meglumine antimoniate (standard treatment).

Treatment:

Drug: Meglumine antimoniate.

Drug: Meglumine antimoniate.

2.1

Experimental group

Description:

Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Miltefosine.

Treatment:

Drug: Miltefosine.

Drug: Miltefosine.

2.2

Active Comparator group

Description:

Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Meglumine antimoniate (standard treatment).

Treatment:

Drug: Meglumine antimoniate.

Drug: Meglumine antimoniate.