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

Cutaneous Leishmaniasis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973128
• Other study ID #: GMCSFAntimonyCL
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2009
• Last updated: September 8, 2009
• Start date: February 2004
• Est. completion date: May 2007

Study information

• Verified date: September 2009
• Source: Hospital Universitário Professor Edgard Santos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

Drug:
• GMCSF plus Antimony reduced dose
400 µg, divided in two doses a week apart, antimony (20mg/daily for 10 days)
• Meglumine antimoniate
20mg/daily for 20 days

Locations

Country	Name	City	State
Brazil	Health Post of Corte de Pedra	Valença	Bahia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitário Professor Edgard Santos	Fundação de Amparo à Pesquisa do Estado da Bahia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate or complete cicatrization of the ulcer		3 months after treatment	Yes
Secondary	Initial cure rate or complete cicatrization of the ulcer.		2 months after treatment.	Yes