Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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 and cutaneous leishmaniasis caused by L. brasiliensis. The study hypothesis is that early intervention with antihelminthic therapy will improve response rates to antimony in subjects with cutaneous leishmaniasis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitário Professor Edgard Santos
• Treatments: Anthelmintics

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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