Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis

NCT ID: NCT01381055

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-10-31

Brief Summary

The purpose of this study is to determine whether pentoxifylline associated to pentavalent antimony has a higher cure rate than pentavalent antimony alone in the treatment of cutaneous leishmaniasis.

Conditions

Cutaneous Leishmaniasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pentoxifylline plus antimony

Group Type: EXPERIMENTAL

Pentoxifylline

Intervention Type: DRUG

Patients with cutaneous leishmaniasis treated with pentavalent antimony/Meglumine antimoniate 20mg/kg/day during 20 days and pentoxifylline pills 400mg three times a day during 20 days.

Placebo plus antimony

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients with cutaneous leishmaniasis treated with pentavalent antimony/metilglucamine 20mg/kg/day during 20 days and placebo pills three times a day during 20 days.

Interventions

Pentoxifylline

Patients with cutaneous leishmaniasis treated with pentavalent antimony/Meglumine antimoniate 20mg/kg/day during 20 days and pentoxifylline pills 400mg three times a day during 20 days.

Intervention Type: DRUG

Placebo

Patients with cutaneous leishmaniasis treated with pentavalent antimony/metilglucamine 20mg/kg/day during 20 days and placebo pills three times a day during 20 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
• Number of lesions: 1 to 3 ulcerative lesions.
• Lesion´s diameter: 1 to 5 cm.
• Disease duration: up to three months.

Exclusion Criteria

• Safety concerns:

• AST, ALT >3 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/biopsy/PCR)or negative Montenegro test
• Any history of prior anti-leishmania therapy
• Any condition which compromises ability to comply with the study procedures
• 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: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT)

UNKNOWN

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Federal University of Bahia

OTHER

Sponsor Role: collaborator

Paulo Roberto Lima Machado

OTHER

Sponsor Role: lead

Responsible Party

Paulo Roberto Lima Machado

Associate Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paulo Roberto L Machado, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Bahia

Locations

Posto de Saúde de Corte de Pedra

Corte de Pedra, Tancredo Neves/Bahia, Brazil

Countries

Brazil

Other Identifiers

LCPX2011

Identifier Type: -

Identifier Source: org_study_id