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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Parasitic Diseases
Protozoan Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Parasitic
Meglumine antimoniate
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014