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

Primary Purpose

Cutaneous Leishmaniasis

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
GMCSF plus Antimony reduced dose
Meglumine antimoniate
Sponsored by
Hospital Universitário Professor Edgard Santos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Leishmaniasis

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Health Post of Corte de Pedra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm 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)

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

Outcomes

Primary Outcome Measures

Cure rate or complete cicatrization of the ulcer

Secondary Outcome Measures

Initial cure rate or complete cicatrization of the ulcer.

Full Information

First Posted
September 8, 2009
Last Updated
September 8, 2009
Sponsor
Hospital Universitário Professor Edgard Santos
Collaborators
Fundação de Amparo à Pesquisa do Estado da Bahia
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1. Study Identification

Unique Protocol Identification Number
NCT00973128
Brief Title
Reduced Doses of Antimony Plus Ranulocyte Monocyte Colony Stimulating Factor (GM-CSF) for Cutaneous Leishmaniasis
Acronym
GMCSFSbv
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 Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Universitário Professor Edgard Santos
Collaborators
Fundação de Amparo à Pesquisa do Estado da Bahia

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Leishmaniasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm 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)
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Group 2: antimony in standard dose plus saline administered in an identical fashion to the GM-CSF.
Intervention Type
Drug
Intervention Name(s)
GMCSF plus Antimony reduced dose
Other Intervention Name(s)
Sargramostim
Intervention Description
400 µg, divided in two doses a week apart, antimony (20mg/daily for 10 days)
Intervention Type
Drug
Intervention Name(s)
Meglumine antimoniate
Other Intervention Name(s)
pentavalent antimony
Intervention Description
20mg/daily for 20 days
Primary Outcome Measure Information:
Title
Cure rate or complete cicatrization of the ulcer
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
Initial cure rate or complete cicatrization of the ulcer.
Time Frame
2 months after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roque P Almeida, MD, PhD
Organizational Affiliation
Hospital Universitário Prof Edgard Santos-UFBA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Post of Corte de Pedra
City
Valença
State/Province
Bahia
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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