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The Effect of Praziquantel Treatment on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria, Uganda

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ClinicalTrials.gov Identifier: NCT00215267
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 21, 2008
Sponsor:
Collaborator:
Ministry of Health, Uganda
Information provided by:
DBL -Institute for Health Research and Development

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Schistosomiasis Malaria Drug: praziquantel Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. cure rates
  2. re-infection
  3. pathology regression

Eligibility Criteria
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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age > 7 years Residence in project village

Exclusion Criteria:

  • persons treated with praziquantel within 2 weeks before recruitment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215267


Locations
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Uganda
Musoli village
Busuyi parish, Mayuge District, Uganda
Sponsors and Collaborators
DBL -Institute for Health Research and Development
Ministry of Health, Uganda
Investigators
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Principal Investigator: Edridah M Tukahebwa, Msc Ministry of Health, Uganda
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00215267    
Other Study ID Numbers: HS02310105
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 21, 2008
Last Verified: February 2008
Keywords provided by DBL -Institute for Health Research and Development:
Schistosoma mansoni
hepatosplenomegaly
malaria
Uganda
Additional relevant MeSH terms:
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Malaria
Schistosomiasis
Reinfection
Infections
Protozoan Infections
Parasitic Diseases
Vector Borne Diseases
Trematode Infections
 Helminthiasis
Recurrence
Disease Attributes
Pathologic Processes
Praziquantel
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents