Epidemiology and Control of Mansonella Perstans Infection in Uganda

This study has been completed.

Sponsor:

Collaborator:

Vector control Division, Kampala, Uganda

Information provided by:

DBL -Institute for Health Research and Development

ClinicalTrials.gov Identifier:

NCT00215280

First received: September 21, 2005

Last updated: April 19, 2007

Last verified: April 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 21, 2005

Last Updated Date

April 19, 2007

Start Date ^ICMJE

November 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00215280 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

treatment effect on clinical manifestations

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Epidemiology and Control of Mansonella Perstans Infection in Uganda

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Mansonelliasis
Pruritus
Lymphoedema
Abdominal Pains

Intervention ^ICMJE

Drug: ivermectin and albendazole

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1000

Completion Date

February 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Individuals < 5 years
Pregnant women

Gender

Both

Ages

5 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Uganda

Administrative Information

NCT Number ^ICMJE

NCT00215280

Other Study ID Numbers ^ICMJE

MV917090205

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

DBL -Institute for Health Research and Development

Collaborators ^ICMJE

Vector control Division, Kampala, Uganda

Investigators ^ICMJE

Principal Investigator:

Asanta M Asio, Msc

Vector control Division, Kampala, Uganda

Information Provided By

DBL -Institute for Health Research and Development

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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