Cutaneous Leishmaniasis Clinical Trial
— LowdosesbOfficial title:
Phase IV Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Low-Dose Pentavalent Antimony Compared to the Standard Dose in Patients With Cutaneous Leishmaniasis Caused by Leishmania (Viannia)Braziliensis
Verified date | January 2009 |
Source | University of Brasilia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Health Surveillance Agency |
Study type | Interventional |
The purpose of this study is to determine whether low-dose pentavalent antimony is equally effective when compared to the standard-dose regimen in patients with cutaneous leishmaniasis. The study will be done in a field clinic in the state of Bahia, Brazil.
Status | Completed |
Enrollment | 280 |
Est. completion date | December 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 7 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Presence of 1 to 9 cutaneous lesions clinically compatible with leishmaniasis - Disease duration of 2 to 20 weeks - Positive leishmanin skin test - Parasitological diagnosis confirmed through culture or genus-specific polymerase chain reaction (PCR) for Leishmania spp Exclusion Criteria: - History of past episode of leishmaniasis - Mucosal disease - Disseminated disease - Use of drugs with anti-leishmanial activity - Contraindications for using pentavalent antimony: - pregnancy - renal failure - heart failure - hepatic failure - Other diseases: - active tuberculosis - hanseniasis |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Núcleo de Medicina Tropical, University of Brasilia | Brasilia | Distrito Federal |
Lead Sponsor | Collaborator |
---|---|
University of Brasilia | Ministry of Health, Brazil |
Brazil,
Oliveira-Neto MP, Schubach A, Mattos M, Goncalves-Costa SC, Pirmez C. A low-dose antimony treatment in 159 patients with American cutaneous leishmaniasis: extensive follow-up studies (up to 10 years). Am J Trop Med Hyg. 1997 Dec;57(6):651-5. — View Citation
Oliveira-Neto MP, Schubach A, Mattos M, Gonçalves-Costa SC, Pirmez C. Treatment of American cutaneous leishmaniasis: a comparison between low dosage (5 mg/kg/day) and high dosage (20 mg/kg/day) antimony regimens. Pathol Biol (Paris). 1997 Jun;45(6):496-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of clinically cured patients at the third month after treatment | Three months after treatment | No | |
Primary | Proportion of patients with epithelialized lesions | Three months after treatment | No | |
Secondary | Proportion of patients with adherence to the protocol prescribed drug | 30 days | No | |
Secondary | Proportion of patients with adverse events | 30 days after treatment | Yes | |
Secondary | Proportion of patients with late failure after the first three months of follow-up | 12 months | No |
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