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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitário Professor Edgard Santos
• Collaborator: Fundação de Amparo à Pesquisa do Estado da Bahia
• Treatments: Meglumine Antimoniate; Sargramostim

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