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NCT00215280 Clinical Trial

Epidemiology and Control of Mansonella Perstans Infection in Uganda

Pruritus Clinical Trial

Official title:
Studies on the Epidemiology and Control of Mansonella Perstans Infection in Uganda

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00215280
Other study ID # MV917090205
Secondary ID
Status Completed
Phase N/A
First received September 21, 2005
Last updated April 19, 2007
Start date November 2005
Est. completion date February 2006

Study information
Verified date April 2007
Source DBL -Institute for Health Research and Development
Contact n/a
Is FDA regulated No
Health authority Uganda: National Council for Science and Technology
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years and older
Eligibility Inclusion Criteria:

- Individuals >= 5 years with or without M. perstans infection

Exclusion Criteria:

- Individuals < 5 years

- Pregnant women

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ivermectin and albendazole

Locations
Country Name City State
Uganda Luwero Luwero and Mukono Luwero and Mukono Districts

Sponsors (2)
Lead Sponsor Collaborator
DBL -Institute for Health Research and Development Ministry of Health, Uganda

Country where clinical trial is conducted

Uganda, 

Outcome
Type Measure Description Time frame Safety issue
Primary microfilariae periodicity patterns
Primary epidemiology of M. perstans at community level
Primary clinical spectre among infected
Primary reduction in microfilaraemia
Secondary treatment effect on clinical manifestations
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