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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00600548
Other study ID # D-18506
Secondary ID 410559/2006-7
Status Completed
Phase Phase 2
First received January 2, 2008
Last updated April 14, 2010
Start date July 2007
Est. completion date July 2009

Study information

Verified date March 2010
Source Hospital Universitário Professor Edgard Santos
Contact n/a
Is FDA regulated No
Health authority Brazil: Universidade Federal da BahiaBrazil: Fundação de Medicina Tropical do AmazonasBrazil: Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)Brazil: Ministério da Ciência e Tecnologia
Study type Interventional

Clinical Trial 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®).


Recruitment information / eligibility

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.

- LesionĀ“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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Miltefosine.
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.
Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.
Miltefosine.
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.
Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.

Locations

Country Name City State
Brazil Fundação de Medicina Tropical do Amazonas Manaus Amazonas
Brazil Posto de Saúde de Corte de Pedra Tancredo Neto Bahia

Sponsors (5)

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

Country where clinical trial is conducted

Brazil, 

Outcome

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