Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

NCT ID: NCT00600548

Last Updated: 2010-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-07-31

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®).

Conditions

Treatment of Cutaneous Leishmaniasis in Brazil.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1.1

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

Group Type: EXPERIMENTAL

Miltefosine.

Intervention Type: DRUG

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.

1.2

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

Group Type: ACTIVE_COMPARATOR

Meglumine antimoniate.

Intervention Type: DRUG

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

2.1

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

Group Type: EXPERIMENTAL

Miltefosine.

Intervention Type: DRUG

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.

2.2

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

Group Type: ACTIVE_COMPARATOR

Meglumine antimoniate.

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Meglumine antimoniate.

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

Intervention Type: 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.

Intervention Type: DRUG

Meglumine antimoniate.

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

Intervention Type: DRUG

Other Intervention Names

Impavido.; Glucantime.; Impavido.; Glucantime.

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
• 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Ministerio de Ciencia e Innovación, Spain

OTHER_GOV

Sponsor Role: collaborator

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role: collaborator

AEterna Zentaris

INDUSTRY

Sponsor Role: collaborator

Hospital Universitário Professor Edgard Santos

OTHER

Sponsor Role: lead

Responsible Party

Universidade Federal da Bahia

Principal Investigators

Paulo RL Machado, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Bahia

Locations

Fundação de Medicina Tropical do Amazonas

Manaus, Amazonas, Brazil

Posto de Saúde de Corte de Pedra

Tancredo Neto, Estado de Bahia, Brazil

Countries

Brazil

References

Machado PR, Ampuero J, Guimaraes LH, Villasboas L, Rocha AT, Schriefer A, Sousa RS, Talhari A, Penna G, Carvalho EM. Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial. PLoS Negl Trop Dis. 2010 Dec 21;4(12):e912. doi: 10.1371/journal.pntd.0000912.

Reference Type: DERIVED

PMID: 21200420 (View on PubMed)

Other Identifiers

410559/2006-7

Identifier Type: -

Identifier Source: secondary_id

D-18506

Identifier Type: -

Identifier Source: org_study_id