- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00215280
Epidemiology and Control of Mansonella Perstans Infection in Uganda
April 19, 2007 updated by: DBL -Institute for Health Research and Development
Studies on the Epidemiology and Control of Mansonella Perstans Infection in Uganda
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Luwero and Mukono Districts
-
Luwero and Mukono, Luwero and Mukono Districts, Uganda
- Luwero
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Individuals >= 5 years with or without M. perstans infection
Exclusion Criteria:
- Individuals < 5 years
- Pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
microfilariae periodicity patterns
|
epidemiology of M. perstans at community level
|
clinical spectre among infected
|
reduction in microfilaraemia
|
Secondary Outcome Measures
Outcome Measure |
---|
treatment effect on clinical manifestations
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Asanta M Asio, Msc, Ministry of Health, Uganda
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Study Completion
February 1, 2006
Study Registration Dates
First Submitted
September 21, 2005
First Submitted That Met QC Criteria
September 21, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
April 20, 2007
Last Update Submitted That Met QC Criteria
April 19, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Lymphatic Diseases
- Pain
- Neurologic Manifestations
- Signs and Symptoms, Digestive
- Parasitic Diseases
- Skin Manifestations
- Spirurida Infections
- Secernentea Infections
- Nematode Infections
- Helminthiasis
- Filariasis
- Lymphedema
- Abdominal Pain
- Pruritus
- Dipetalonema Infections
- Acanthocheilonemiasis
- Mansonelliasis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiprotozoal Agents
- Antiparasitic Agents
- Anthelmintics
- Antiplatyhelmintic Agents
- Anticestodal Agents
- Ivermectin
- Albendazole
Other Study ID Numbers
- MV917090205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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