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

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Brief Title

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

Official Title

The Effect of One Versus Two Praziquantel Treatments on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria in Uganda

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.
    

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 Type

Interventional


Primary Outcome

cure rates


Condition

Schistosomiasis

Intervention

praziquantel


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

540

Start Date

September 2005

Completion Date

October 2007

Primary Completion Date

September 2007

Eligibility Criteria

        Inclusion Criteria:

          -  age > 7 years Residence in project village

        Exclusion Criteria:

          -  persons treated with praziquantel within 2 weeks before recruitment
      

Gender

All

Ages

8 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Edridah M Tukahebwa, Msc, , 

Location Countries

Uganda

Location Countries

Uganda

Administrative Informations


NCT ID

NCT00215267

Organization ID

HS02310105



Study Sponsor

DBL -Institute for Health Research and Development

Collaborators

 Ministry of Health, Uganda

Study Sponsor

Edridah M Tukahebwa, Msc, Principal Investigator, Ministry of Health, Uganda


Verification Date

February 2008