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

Sponsor

DBL -Institute for Health Research and Development (Other)

Overall Status

Completed

CT.gov ID

NCT00215267

Collaborator

Ministry of Health, Uganda (Other)

540

Enrollment

Location

Duration (Months)

21.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schistosomiasis Malaria	Drug: praziquantel	N/A

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 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 Design

Study Type:

Interventional

Anticipated Enrollment :

540 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Outcome Measures

Primary Outcome Measures

cure rates []
re-infection []
pathology regression []

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

age > 7 years Residence in project village

Exclusion Criteria:

persons treated with praziquantel within 2 weeks before recruitment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Musoli village	Busuyi parish	Mayuge District	Uganda

Sponsors and Collaborators

DBL -Institute for Health Research and Development
Ministry of Health, Uganda

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00215267

Other Study ID Numbers:

HS02310105

First Posted:

Sep 22, 2005

Last Update Posted:

Feb 21, 2008

Last Verified:

Feb 1, 2008

Keywords provided by , ,

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2008