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

NCT ID: NCT00215267

Last Updated: 2008-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-10-31

Brief Summary

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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

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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.

Conditions

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Schistosomiasis Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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praziquantel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age \> 7 years Residence in project village

Exclusion Criteria

* persons treated with praziquantel within 2 weeks before recruitment
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, Uganda

OTHER_GOV

Sponsor Role collaborator

DBL -Institute for Health Research and Development

OTHER

Sponsor Role lead

Principal Investigators

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Edridah M Tukahebwa, Msc

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, Uganda

Locations

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Musoli village

Busuyi Parish, Mayuge District, Uganda

Site Status

Countries

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Uganda

References

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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.

Reference Type DERIVED
PMID: 29131820 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23596262 (View on PubMed)

Related Links

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Other Identifiers

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HS02310105

Identifier Type: -

Identifier Source: org_study_id

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