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

Primary Purpose

Schistosomiasis, Malaria

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
praziquantel
Sponsored by
DBL -Institute for Health Research and Development
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schistosomiasis focused on measuring Schistosoma mansoni, hepatosplenomegaly, malaria, Uganda

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: age > 7 years Residence in project village Exclusion Criteria: persons treated with praziquantel within 2 weeks before recruitment

Sites / Locations

  • Musoli village

Outcomes

Primary Outcome Measures

cure rates
re-infection
pathology regression

Secondary Outcome Measures

Full Information

First Posted
September 20, 2005
Last Updated
February 19, 2008
Sponsor
DBL -Institute for Health Research and Development
Collaborators
Ministry of Health, Uganda
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1. Study Identification

Unique Protocol Identification Number
NCT00215267
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
DBL -Institute for Health Research and Development
Collaborators
Ministry of Health, Uganda

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schistosomiasis, Malaria
Keywords
Schistosoma mansoni, hepatosplenomegaly, malaria, Uganda

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
praziquantel
Primary Outcome Measure Information:
Title
cure rates
Title
re-infection
Title
pathology regression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age > 7 years Residence in project village Exclusion Criteria: persons treated with praziquantel within 2 weeks before recruitment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edridah M Tukahebwa, Msc
Organizational Affiliation
Ministry of Health, Uganda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Musoli village
City
Busuyi parish
State/Province
Mayuge District
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
29131820
Citation
Kildemoes AO, Vennervald BJ, Tukahebwa EM, Kabatereine NB, Magnussen P, de Dood CJ, Deelder AM, Wilson S, van Dam GJ. Rapid clearance of Schistosoma mansoni circulating cathodic antigen after treatment shown by urine strip tests in a Ugandan fishing community - Relevance for monitoring treatment efficacy and re-infection. PLoS Negl Trop Dis. 2017 Nov 13;11(11):e0006054. doi: 10.1371/journal.pntd.0006054. eCollection 2017 Nov.
Results Reference
derived
PubMed Identifier
23596262
Citation
Tukahebwa EM, Vennervald BJ, Nuwaha F, Kabatereine NB, Magnussen P. Comparative efficacy of one versus two doses of praziquantel on cure rate of Schistosoma mansoni infection and re-infection in Mayuge District, Uganda. Trans R Soc Trop Med Hyg. 2013 Jun;107(6):397-404. doi: 10.1093/trstmh/trt024. Epub 2013 Apr 17.
Results Reference
derived
Links:
URL
http://www.dblnet.dk
Description
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The Effect of Praziquantel Treatment on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria, Uganda

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