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

September 8, 2009 updated by: Hospital Universitário Professor Edgard Santos

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Bahia
      • Valença, Bahia, Brazil
        • Health Post of Corte de Pedra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cure rate or complete cicatrization of the ulcer
Time Frame: 3 months after treatment
3 months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Initial cure rate or complete cicatrization of the ulcer.
Time Frame: 2 months after treatment.
2 months after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitário Professor Edgard Santos

Collaborators

Fundação de Amparo à Pesquisa do Estado da Bahia

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

September 8, 2009

First Submitted That Met QC Criteria

September 8, 2009

First Posted (Estimate)

September 9, 2009

Study Record Updates

Last Update Posted (Estimate)

September 9, 2009

Last Update Submitted That Met QC Criteria

September 8, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMCSFAntimonyCL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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