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Epidemiology and Control of Mansonella Perstans Infection in Uganda

Primary Purpose

Mansonelliasis, Pruritus, Lymphoedema

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
ivermectin and albendazole
Sponsored by
DBL -Institute for Health Research and Development
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mansonelliasis focused on measuring Mansonella perstans, microfilaraemia, ivermectin, albendazole, Uganda

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Individuals >= 5 years with or without M. perstans infection Exclusion Criteria: Individuals < 5 years Pregnant women

Sites / Locations

  • Luwero

Outcomes

Primary Outcome Measures

microfilariae periodicity patterns
epidemiology of M. perstans at community level
clinical spectre among infected
reduction in microfilaraemia

Secondary Outcome Measures

treatment effect on clinical manifestations

Full Information

First Posted
September 21, 2005
Last Updated
April 19, 2007
Sponsor
DBL -Institute for Health Research and Development
Collaborators
Ministry of Health, Uganda
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1. Study Identification

Unique Protocol Identification Number
NCT00215280
Brief Title
Epidemiology and Control of Mansonella Perstans Infection in Uganda
Official Title
Studies on the Epidemiology and Control of Mansonella Perstans Infection in Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
DBL -Institute for Health Research and Development
Collaborators
Ministry of Health, Uganda

4. Oversight

5. Study Description

Brief 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.
Detailed Description
Overall objective: to investigate diagnostic, epidemiological and treatment aspects of M. perstans in Uganda with relevance to control Specific objectives: To establish the pattern of diurnal periodicity of M. perstans microfilaraemia in humans To establish the patterns of M. perstans microfilaraemia and possible clinical manifestations related to this infection in two communities with medium to high endemicity To determine the efficacy of ivermectin alone and the combination of ivermectin and albendazole on M. perstans microfilaraemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mansonelliasis, Pruritus, Lymphoedema, Abdominal Pains
Keywords
Mansonella perstans, microfilaraemia, ivermectin, albendazole, Uganda

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
1000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ivermectin and albendazole
Primary Outcome Measure Information:
Title
microfilariae periodicity patterns
Title
epidemiology of M. perstans at community level
Title
clinical spectre among infected
Title
reduction in microfilaraemia
Secondary Outcome Measure Information:
Title
treatment effect on clinical manifestations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals >= 5 years with or without M. perstans infection Exclusion Criteria: Individuals < 5 years Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asanta M Asio, Msc
Organizational Affiliation
Ministry of Health, Uganda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luwero
City
Luwero and Mukono
State/Province
Luwero and Mukono Districts
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
19081121
Citation
Asio SM, Simonsen PE, Onapa AW. A randomised, double-blind field trial of ivermectin alone and in combination with albendazole for the treatment of Mansonella perstans infections in Uganda. Trans R Soc Trop Med Hyg. 2009 Mar;103(3):274-9. doi: 10.1016/j.trstmh.2008.10.038. Epub 2008 Dec 9.
Results Reference
derived
PubMed Identifier
18809192
Citation
Asio SM, Simonsen PE, Onapa AW. Mansonella perstans filariasis in Uganda: patterns of microfilaraemia and clinical manifestations in two endemic communities. Trans R Soc Trop Med Hyg. 2009 Mar;103(3):266-73. doi: 10.1016/j.trstmh.2008.08.007. Epub 2008 Sep 21.
Results Reference
derived
Links:
URL
http://www.dblnet.dk
Description
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Epidemiology and Control of Mansonella Perstans Infection in Uganda

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