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

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ClinicalTrials.gov Identifier: NCT00973128
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : September 9, 2009
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado da Bahia
Information provided by:
Hospital Universitário Professor Edgard Santos

Tracking Information
First Submitted Date  ICMJE September 8, 2009
First Posted Date  ICMJE September 9, 2009
Last Update Posted Date September 9, 2009
Study Start Date  ICMJE February 2004
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2009)
Cure rate or complete cicatrization of the ulcer [ Time Frame: 3 months after treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2009)
Initial cure rate or complete cicatrization of the ulcer. [ Time Frame: 2 months after treatment. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reduced Doses of Antimony Plus Ranulocyte Monocyte Colony Stimulating Factor (GM-CSF) for Cutaneous Leishmaniasis
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cutaneous Leishmaniasis
Intervention  ICMJE
  • Drug: GMCSF plus Antimony reduced dose
    400 µg, divided in two doses a week apart, antimony (20mg/daily for 10 days)
    Other Name: Sargramostim
  • Drug: Meglumine antimoniate
    20mg/daily for 20 days
    Other Name: pentavalent antimony
Study Arms  ICMJE
  • 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)
    Intervention: Drug: GMCSF plus Antimony reduced dose
  • Active Comparator: Group 2
    Group 2: antimony in standard dose plus saline administered in an identical fashion to the GM-CSF.
    Intervention: Drug: Meglumine antimoniate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2009)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00973128
Other Study ID Numbers  ICMJE GMCSFAntimonyCL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roque Pacheco de Almeida, Hospital Universitário Prof. Edgard Santos
Study Sponsor  ICMJE Hospital Universitário Professor Edgard Santos
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado da Bahia
Investigators  ICMJE
Principal Investigator: Roque P Almeida, MD, PhD Hospital Universitário Prof Edgard Santos-UFBA
PRS Account Hospital Universitário Professor Edgard Santos
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP