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| Tracking Information | |||||
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| First Received Date ICMJE | April 19, 2007 | ||||
| Last Updated Date | October 30, 2007 | ||||
| Start Date ICMJE | April 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00463307 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | 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 ICMJE | 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 | ||||
| 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 |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Other | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1100 | ||||
| Completion Date | November 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 10 Years to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Kenya | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00463307 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | SRP-KY-JK-06 | ||||
| Study Sponsor ICMJE | DBL -Institute for Health Research and Development | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | DBL -Institute for Health Research and Development | ||||
| Verification Date | October 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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