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

NCT00973128 | Completed Phase 2

• 1 other identifier: GMCSFAntimonyCL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Leishmaniasis

Outcome Measures

Primary Outcomes (1)

• Cure rate or complete cicatrization of the ulcer

  3 months after treatment

Secondary Outcomes (1)

• Initial cure rate or complete cicatrization of the ulcer.

  2 months after treatment.

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

ACTIVE COMPARATOR

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

Drug: Meglumine antimoniate

Interventions

GMCSF plus Antimony reduced dose DRUG

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

Also known as: Sargramostim

Group 1

Meglumine antimoniate DRUG

20mg/daily for 20 days

Also known as: pentavalent antimony

Group 2

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 15 and 50 years
• Either gender
• Diagnosis of cutaneous leishmaniasis
• Less than 60 days of disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitário Professor Edgard Santos: lead
• Fundação de Amparo à Pesquisa do Estado da Bahia: collaborator

Study Sites (1)

Health Post of Corte de Pedra

Valença, Estado de Bahia, Brazil

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

sargramostim; Meglumine Antimoniate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Meglumine; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Hexosamines; Amino Sugars; Carbohydrates

Study Officials

• Roque P Almeida, MD, PhD

  Hospital Universitário Prof Edgard Santos-UFBA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 9, 2009
• Study Start: February 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: May 1, 2007
• Last Updated: September 9, 2009

Record last verified: 2009-09

Locations

BR (1)