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

H

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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