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Completed

NCT Number: NCT00973128

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

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.

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Key information

Conditions

Cutaneous Leishmaniasis Euglenozoa Infections Infections Leishmaniasis Leishmaniasis, Cutaneous Parasitic Diseases Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Vector Borne Diseases

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Health Post of Corte de Pedra

Valença, Estado de Bahia, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GMCSF plus Antimony reduced dose

Drug

400 µg, divided in two doses a week apart, antimony (20mg/daily for 10 days)

Other names: Sargramostim

Meglumine antimoniate

Drug

20mg/daily for 20 days

Other names: pentavalent antimony

Primary outcomes

  1. Cure rate or complete cicatrization of the ulcer

    Time frame: 3 months after treatment

Secondary outcomes

  1. Initial cure rate or complete cicatrization of the ulcer.

    Time frame: 2 months after treatment.

Sponsors and collaborators

Lead sponsor

Hospital Universitário Professor Edgard Santos

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado da Bahia

Registry information

Official study 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

Acronym: GMCSFSbv

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
Sep 9, 2009
Registry last updated
Sep 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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