Reduced Doses of Antimony Plus Ranulocyte Monocyte Colony Stimulating Factor (GM-CSF) for Cutaneous Leishmaniasis

NCT ID: NCT00973128

Last Updated: 2009-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2007-05-31

Brief Summary

The present study was designed as a randomized, single blind, placebo-controlled, study to evaluate the effect of 400 µg of recombinant human GM-CSF applied intralesionally and associated with half of the total dose of antimony in a reduced time schedule (20mgSbV/Kg/d for 10 days) as compared to the full dose of antimony (20mgSbV/Kg/d for 20 days) to treat cutaneous leishmaniasis ulcers.

Detailed Description

This is a randomized, single blind placebo-controlled study in which the groups were selected from the cases presenting to the health post. The inclusion criteria were: age between 15 and 50 years, of either sex, diagnosis of cutaneous leishmaniasis of less than 60 days. The diagnostic criteria were the presence of a typical single cutaneous ulcer, localized on lower limbs, and a positive delayed type hypersensitivity test (DTH or Montenegro skin test) to Leishmania antigen.

Conditions

Cutaneous Leishmaniasis

Study Design

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

Study Groups

Group 1

Group 1: Cutaneous leishmaniasis patients randomized in Corte to receive antimony (20mg/daily for 10 days) plus GM-CSF Treatment: antimony (20mg/daily for 10 days) plus GM-CSF (400 µg, divided in two doses a week apart)

Group Type: EXPERIMENTAL

GMCSF plus Antimony reduced dose

Intervention Type: DRUG

400 µg, divided in two doses a week apart, antimony (20mg/daily for 10 days)

Group 2

Group 2: antimony in standard dose plus saline administered in an identical fashion to the GM-CSF.

Group Type: ACTIVE_COMPARATOR

Meglumine antimoniate

Intervention Type: DRUG

20mg/daily for 20 days

Interventions

GMCSF plus Antimony reduced dose

400 µg, divided in two doses a week apart, antimony (20mg/daily for 10 days)

Intervention Type: DRUG

Meglumine antimoniate

20mg/daily for 20 days

Intervention Type: DRUG

Other Intervention Names

Sargramostim; pentavalent antimony

Eligibility Criteria

Inclusion Criteria

• Age between 15 and 50 years
• Either gender
• Diagnosis of cutaneous leishmaniasis
• Less than 60 days of disease

Exclusion Criteria

• Any history of prior anti-leishmania therapy
• Negative parasitology (aspirate/smear)or negative Montenegro test
• Pregnancy
• Age below 15 and above 50 years
• Other associated acute or chronic illnesses
• History of allergy to GM-CSF and/or antimony
• HIV, HTLV-1 infections or diabetes
• 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: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado da Bahia

OTHER

Sponsor Role: collaborator

Hospital Universitário Professor Edgard Santos

OTHER

Sponsor Role: lead

Responsible Party

Hospital Universitário Prof. Edgard Santos

Principal Investigators

Roque P Almeida, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitário Prof Edgard Santos-UFBA

Locations

Health Post of Corte de Pedra

Valença, Estado de Bahia, Brazil

Countries

Brazil

Other Identifiers

GMCSFAntimonyCL

Identifier Type: -

Identifier Source: org_study_id