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CompletedNCT00215267Updated Feb 21, 2008

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

An interventional study of praziquantel in Schistosomiasis and Malaria, sponsored by DBL -Institute for Health Research and Development. Completed at 1 site in Uganda. Open to participants aged 8 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-02-21.

Sponsored by DBL -Institute for Health Research and Development · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
540
Allocation
Randomized
Ages
8 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Schistosomiasis
  • Malaria

Keywords

  • Schistosoma mansoni
  • hepatosplenomegaly
  • malaria
  • Uganda
03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's planned enrollment of 540 is above the median of 220 across 1,027 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

DBL -Institute for Health Research and Development is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • age > 7 years Residence in project village

Exclusion criteria

Exclusion Criteria:

  • persons treated with praziquantel within 2 weeks before recruitment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
540 participants (estimated)

Interventions

  • Drugpraziquantel
06

What researchers measure

Primary outcomes

  1. cure rates

  2. re-infection

  3. pathology regression

07

Study locations

1 site
  • Musoli village
    Busuyi parish, Mayuge District, Uganda
08

References and documents

Publications

  • 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. PubMed 29131820 ↗
  • 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. PubMed 23596262 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00215267
Lead sponsor
DBL -Institute for Health Research and Development
Collaborators
Ministry of Health, Uganda
First posted
Sep 22, 2005
Start date
Sep 2005
Primary completion
Sep 2007
Completion
Oct 2007
Last update
Feb 21, 2008

Study contacts

Edridah M Tukahebwa, Msc
principal investigator · Ministry of Health, Uganda
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

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