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Evaluation of the Use of a Urin Test Strip to Determine the Spread of Schistosoma Infections in Areas Where Schistosomiasis Infections Are Low in Kenya

Primary Purpose

Schistosomiasis Mansoni, Circulating Cathodic Antigen Urine Based Dipstick

Status

Completed

Phase

Locations

Kenya

Study Type

Observational

Intervention

About this trial

This is an observational trial for Schistosomiasis Mansoni focused on measuring schistosomiasis, Schistosoma mansoni, Circulating cathodic antigen urine dipstick

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Children in the age between 10 and 18 years

Exclusion Criteria:

Children younger then 10 years of age and children whos parent/guardians did not give informed consents for their participation in the study

Sites / Locations

Kenya Medical Research Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00463307

First Posted

April 19, 2007

Last Updated

October 30, 2007

Sponsor

DBL -Institute for Health Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT00463307

Brief Title

Evaluation of the Use of a Urin Test Strip to Determine the Spread of Schistosoma Infections in Areas Where Schistosomiasis Infections Are Low in Kenya

Official Title

Evaluation of Applicability of Urine Based Schistosomiasis Test Strip in the Epidemiologic Mapping and Sampling of Schistosoma Mansoni Infection in Low Endemic Areas of Kenya

Study Type

Observational

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

DBL -Institute for Health Research and Development

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the use of a urine test strip in diagnose schistosoma mansoni in areas of Kenya where the rate of infections are low. The hypothesis is that the urine strip test is a superior tool to the conventional parasitological tools used to diagnose schistosomiasis mansoni infections in area where there is low transmission

Detailed Description

The study will compare the use of the urine test strip with the conventional method used and with a "golden standard" methode, in an area of Kenya where the infection transmission is low. Furthermore will the urine test strip be evaluatied in its ability to monitor the intensity of infections in school children before and after they are been treated for the infections. A total of 1100 school children in the age between 10 and 18 years will be included in the study. Children have to submitt a stool and a urine sample on three consecutive days. Children who are found to be infected with the schistosomiasis parasite will be offered treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schistosomiasis Mansoni, Circulating Cathodic Antigen Urine Based Dipstick

Keywords

schistosomiasis, Schistosoma mansoni, Circulating cathodic antigen urine dipstick

7. Study Design

Enrollment

1100 (Actual)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Children in the age between 10 and 18 years Exclusion Criteria: Children younger then 10 years of age and children whos parent/guardians did not give informed consents for their participation in the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hussein J Kihara, mr

Organizational Affiliation

Division of Vector Borne Diseases, Kenya

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kenya Medical Research Institute

City

Nairobi

Country

Kenya

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Use of a Urin Test Strip to Determine the Spread of Schistosoma Infections in Areas Where Schistosomiasis Infections Are Low in Kenya

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