The Effect of Praziquantel Treatment on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria, Uganda
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Purpose
The overall objective of the project is to contribute to an increased knowledge about the effect of praziquantel on schistosomiasis related morbidity and re-infection level among communities living along Lake Victoria in Mayuge district, Uganda with the overall aim of improving the strategies for morbidity control.
The study will be carried out in a high transmission area along Lake Victoria, in Mayuge district. It will be a randomised intervention study, comparing a single praziquantel treatment (40mg/kg) with two standard doses administered two weeks apart.
| Condition | Intervention |
|---|---|
|
Schistosomiasis Malaria |
Drug: praziquantel |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effect of One Versus Two Praziquantel Treatments on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria in Uganda |
- cure rates
- re-infection
- pathology regression
| Estimated Enrollment: | 540 |
| Study Start Date: | September 2005 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
In Uganda, schistosomiasis affects approximately 10% of the population and transmission takes place along all large water bodies (rivers and lakes).
Morbidity control should aim at increasing the length of time before morbidity reappears and decrease the time during which morbidity regresses in a situation with continued transmission and re-infection. It is proposed to test this by comparing the standard treatment with a double treatment (2 x 40 mg/kg) two weeks apart.
The overall objective of the project is to contribute to an increased knowledge about the effect of praziquantel on schistosomiasis related morbidity and re-infection level among communities living along Lake Victoria in Mayuge district, Uganda with the overall aim of improving the strategies for morbidity control.
The study will be carried out in a high transmission area along Lake Victoria, in Mayuge district. It will be a randomised intervention study, comparing a single praziquantel treatment (40mg/kg) with two standard doses administered two weeks apart. Two groups of participants, with 270 people in each, will be randomly selected and randomly assigned to the two treatment regimens. Three consecutive stool samples will be from the cohort and blood samples for malaria will be examined. Clinical and ultrasonographic examinations will be performed. After all the examinations, the whole cohort will be treated with a single standard dose of praziquantel and albendazole. Two weeks later all members of one of the groups will receive another standard dose of praziquantel. Follow-up examinations will be performed 8 weeks, 6 months and two years later.
Eligibility| Ages Eligible for Study: | 8 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- age > 7 years Residence in project village
Exclusion Criteria:
- persons treated with praziquantel within 2 weeks before recruitment
Contacts and Locations| Uganda | |
| Musoli village | |
| Busuyi parish, Mayuge District, Uganda | |
| Principal Investigator: | Edridah M Tukahebwa, Msc | Vector control Division, Kampala, Uganda |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00215267 History of Changes |
| Other Study ID Numbers: | HS02310105 |
| Study First Received: | September 20, 2005 |
| Last Updated: | February 19, 2008 |
| Health Authority: | Uganda: National Council for Science and Technology |
Keywords provided by DBL -Institute for Health Research and Development:
|
Schistosoma mansoni hepatosplenomegaly malaria Uganda |
Additional relevant MeSH terms:
|
Malaria Schistosomiasis mansoni Schistosomiasis Protozoan Infections Parasitic Diseases Trematode Infections Helminthiasis |
Praziquantel Anthelmintics Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013