Malaria Clinical Trial
Official title:
The Effect of One Versus Two Praziquantel Treatments on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria in Uganda
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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