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

This study has been completed.
Sponsor:
Collaborator:
Vector control Division, Kampala, Uganda
Information provided by:
DBL -Institute for Health Research and Development
ClinicalTrials.gov Identifier:
NCT00215267
First received: September 20, 2005
Last updated: February 19, 2008
Last verified: February 2008
  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

Resource links provided by NLM:


Further study details as provided by DBL -Institute for Health Research and Development:

Primary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215267

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

Additional Information:
No publications provided by DBL -Institute for Health Research and Development

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Protozoan Infections
Parasitic Diseases
Trematode Infections
Helminthiasis
Praziquantel
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014