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

Sponsor
Hospital Universitário Professor Edgard Santos (Other)
Overall Status
Completed
CT.gov ID
NCT00973128
Collaborator
Fundação de Amparo à Pesquisa do Estado da Bahia (Other)
40
Enrollment
1
Location
2
Arms
38.9
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: GMCSF plus Antimony reduced dose
  • Drug: Meglumine antimoniate
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Reduced Doses of Antimony Plus Recombinant Human GM-CSF Compared With Antimony in Standard Doses for Cutaneous Leishmaniasis: a Randomized, Single-blind, Placebo-controlled, Pilot Study
Study Start Date :
Feb 1, 2004
Actual Primary Completion Date :
Oct 1, 2006
Actual Study Completion Date :
May 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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)

Drug: GMCSF plus Antimony reduced dose
400 µg, divided in two doses a week apart, antimony (20mg/daily for 10 days)
Other Names:
  • Sargramostim

    		•
    Active Comparator: Group 2

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

    Drug: Meglumine antimoniate
    20mg/daily for 20 days
    Other Names:
  • pentavalent antimony

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cure rate or complete cicatrization of the ulcer [3 months after treatment]

    Secondary Outcome Measures

    1. Initial cure rate or complete cicatrization of the ulcer. [2 months after treatment.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Health Post of Corte de Pedra Valença Bahia Brazil

    Sponsors and Collaborators

    • Hospital Universitário Professor Edgard Santos
    • Fundação de Amparo à Pesquisa do Estado da Bahia

    Investigators

    • Principal Investigator: Roque P Almeida, MD, PhD, Hospital Universitário Prof Edgard Santos-UFBA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00973128
    Other Study ID Numbers:
    • GMCSFAntimonyCL
    First Posted:
    Sep 9, 2009
    Last Update Posted:
    Sep 9, 2009
    Last Verified:
    Sep 1, 2009
    Additional relevant MeSH terms:
    Leishmaniasis
    Leishmaniasis, Cutaneous
    Meglumine Antimoniate
    Sargramostim

    Study Results

    No Results Posted as of Sep 9, 2009