Mansonella perstans (M. perstans) infection is widespread in Uganda. Knowledge about the epidemiology of this infection, and of the morbidity it induces is poor, and no effective treatment is available. The study aims at providing data on diagnostic, epidemiological, morbidity and treatment aspects of M. perstans infections in Uganda...
Date First Received: September 21, 2005
Last Updated: April 19, 2007
Verified by: DBL -Institute for Health Research and Development, April 2007
Clinical Trial Phase: N/A | Start Date: November 2005
Overall Status: Completed
Estimated Enrollment: 1000
Brief Summary
Official Title: “Studies on the Epidemiology and Control of Mansonella Perstans Infection in Uganda”
Condition Keyword(s):
Intervention(s):
Mansonella perstans (M. perstans) infection is widespread in Uganda. Knowledge about the epidemiology of this infection, and of the morbidity it induces is poor, and no effective treatment is available. The study aims at providing data on diagnostic, epidemiological, morbidity and treatment aspects of M. perstans infections in Uganda.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Detailed Clinical Trial Description
Overall objective: to investigate diagnostic, epidemiological and treatment aspects of M.
perstans in Uganda with relevance to control
Specific objectives:
1. To establish the pattern of diurnal periodicity of M. perstans microfilaraemia in humans
2. To establish the patterns of M. perstans microfilaraemia and possible clinical manifestations related to this infection in two communities with medium to high endemicity
3. To determine the efficacy of ivermectin alone and the combination of ivermectin and albendazole on M. perstans microfilaraemia.
Intervention(s) in this Clinical Trial
- Drug: ivermectin and albendazole
Outcome Measures for this Clinical Trial
Primary Measures
- microfilariae periodicity patterns
- epidemiology of M. perstans at community level
- clinical spectre among infected
- reduction in microfilaraemia
Secondary Measures
- treatment effect on clinical manifestations
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Individuals >= 5 years with or without M. perstans infection
Exclusion Criteria:
- Individuals < 5 years
- Pregnant women
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 5 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: DBL -Institute for Health Research and Development
Overall Clinical Trial Officials and Contacts
Asanta M Asio, Msc Principal Investigator Vector control Division, Kampala, Uganda
Additional Information
Information obtained from ClinicalTrials.gov on December 03, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00215280
Study ID Number: MV917090205
ClinicalTrials.gov Identifier: NCT00215280
Health Authority: Uganda: National Council for Science and Technology
Clinical Trials Authorship and Review
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