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

Hospital Universitário Professor Edgard Santos

Status and phase: Completed; Phase 2

Conditions: Cutaneous Leishmaniasis

Treatments: Drug: GMCSF plus Antimony reduced dose; Drug: Meglumine antimoniate

Study type: Interventional

Funder types: Other

Identifiers

NCT00973128

GMCSFAntimonyCL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 15 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Group 1

Experimental group

Description:

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)

Treatment:

Drug: GMCSF plus Antimony reduced dose

Group 2

Active Comparator group

Description:

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

Treatment:

Drug: Meglumine antimoniate