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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado da Bahia - FAPESB
Information provided by:
Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier:
NCT00973128
First received: September 8, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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 Intervention Phase
Cutaneous Leishmaniasis
Drug: GMCSF plus Antimony reduced dose
Drug: Meglumine antimoniate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Hospital Universitário Professor Edgard Santos:

Primary Outcome Measures:
  • Cure rate or complete cicatrization of the ulcer [ Time Frame: 3 months after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Initial cure rate or complete cicatrization of the ulcer. [ Time Frame: 2 months after treatment. ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: February 2004
Study Completion Date: May 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: pentavalent antimony

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.

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973128

Locations
Brazil
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 - FAPESB
Investigators
Principal Investigator: Roque P Almeida, MD, PhD Hospital Universitário Prof Edgard Santos-UFBA
  More Information

No publications provided

Responsible Party: Roque Pacheco de Almeida, Hospital Universitário Prof. Edgard Santos
ClinicalTrials.gov Identifier: NCT00973128     History of Changes
Other Study ID Numbers: GMCSFAntimonyCL
Study First Received: September 8, 2009
Last Updated: September 8, 2009
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Meglumine antimoniate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014