Status:
COMPLETED
Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis
Lead Sponsor:
Hospital Universitário Professor Edgard Santos
Conditions:
Leishmaniasis, Cutaneous
Helminthiasis
Eligibility:
All Genders
13-50 years
Phase:
NA
Brief Summary
The purpose of this project is to investigate the efficacy of early, empiric anti-helminthic therapy combined with standard pentavalent antimony in the treatment of subjects co-infected with helminths...
Detailed Description
Leishmaniases are a group of diseases caused by a parasite and transmitted by the sand fly. There are a number of diseases associated with infection ranging from simple skin lesions to a severe, fatal...
Eligibility Criteria
Inclusion
- Subjects with a diagnosis of CL based on the presence of typical skin lesions and a positive Montenegro skin test
- Evidence of helminthic infection by parasitological examination of first stool sample
- Males or females between 13 and 50 years of age
- Maximum of 3 ulcers with no more than 2 body regions involved
- Period of 15 to 60 days from the onset of the first ulcer
- Subject agreement to follow-up visits and therapy
- Ability to give informed consent
Exclusion
- Pregnancy
- Breastfeeding mothers
- Presence of mucosal disease
- History of prior treatment with antimonial drugs.
- History of prior treatment with anthelminthic drugs within the last 6 months.
- History of allergy to pentavalent antimony or antihelminthic
- Presence of underlying disease which affects the immune response, such as HIV and diabetes mellitus
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00469495
Start Date
February 1 2007
End Date
November 1 2008
Last Update
August 26 2009
Active Locations (1)
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1
Posto de Saude de Corte de Pedra
Salvador, Estado de Bahia, Brazil