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

• ClinicalTrials.gov Identifier: NCT00215267
• Recruitment Status: Completed
• First Posted: September 22, 2005
• Last Update Posted: February 21, 2008
• Sponsor: DBL -Institute for Health Research and Development
• Collaborator: Ministry of Health, Uganda
• Information provided by: DBL -Institute for Health Research and Development

Tracking Information

• First Submitted Date: September 20, 2005
• First Posted Date: September 22, 2005
• Last Update Posted Date: February 21, 2008
• Study Start Date: September 2005
• Actual Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 20, 2005)

• cure rates
• re-infection
• pathology regression

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Schistosomiasis
• Malaria

• Intervention: Drug: praziquantel
• Study Arms: Not Provided

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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: September 20, 2005): 540
• Original Enrollment: Same as current
• Actual Study Completion Date: October 2007
• Actual Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• age > 7 years Residence in project village

Exclusion Criteria:

• persons treated with praziquantel within 2 weeks before recruitment

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 8 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Uganda

Administrative Information

• NCT Number: NCT00215267
• Other Study ID Numbers: HS02310105
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: DBL -Institute for Health Research and Development
• Original Study Sponsor: Same as current
• Collaborators: Ministry of Health, Uganda

Investigators

• Principal Investigator: Edridah M Tukahebwa, Msc; Ministry of Health, Uganda

• PRS Account: DBL -Institute for Health Research and Development
• Verification Date: February 2008