Schistosoma Mansoni in Mwanza Region, Tanzania

Schistosoma Mansoni Clinical Trial

— SCORE_PAR  

Official title:

Parasitologic Impact of Different Mass Drug Administration Strategies Against Schistosoma Mansoni in Endemic Areas of Mwanza Region, Tanzania, Where Prevalence is 25% or Above

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162875
• Other study ID #: TAN-score
• Secondary ID: BMGF
• Status: Completed
• Phase: N/A
• First received: May 26, 2014
• Last updated: February 9, 2017
• Start date: March 2011
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: DBL -Institute for Health Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine the strategy for mass drug administration (MDA) which provides the greatest reductions in prevalence and intensity of Schistosoma mansoni in school-aged children after 4 years of intervention.

Description:

Intestinal schistosomiasis is caused by the blood-dwelling flatworm Schistosoma mansoni. Despite the increasing focus on the use of praziquantel against schistosomiasis infections for the last three decades many areas in Sub-Saharan Africa still have high prevalences and intensities of schistosomiasis especially among school-age children. This is true for the area of Mwanza Region of Tanzania adjacent to Lake Victoria. The study is a six arm study and includes 150 communities (25 in each arm). From each community 100 school children (aged 9-12 years), 100 first year students (aged 7-8 years) and 50 adults (aged 20-55 years) are included, diagnosed and treated with praziquantel using strategies composing of a mixture of community wide treatment (CWT), school-based treatment (SBT) and years without treatment (-T). The 100 school children provided stool specimens on three consecutive days, while the 100 first year students and 50 adults with few exceptions only provided one specimen. The treatment strategies during the 4 years for the different arms are as follows: Arm 1: CWT, CWT, CWT, CWT; Arm 2: CWT, CWT, SBT, SBT; Arm 3: CWT, CWT -T, -T; Arm 4: SBT, SBT, SBT, SBT; Arm 5: SBT, SBT, -T, -T; Arm 6: SBT, -T, SBT, -T.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37500
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 55 Years

Eligibility

Inclusion Criteria:

-All school children and adults who consent to participate can be included

Exclusion Criteria:

-Those not consenting or with any chronic disease not related to schistosomiasis will be excluded

Related Conditions & MeSH terms

• Schistosoma Mansoni

Intervention

Drug:
• Praziquantel
Six different treatment strategies with praziquantel

Locations

Country	Name	City	State
Tanzania	National Institute for Mediacal Research	Mwanza	Lake Region

Sponsors (1)

Lead Sponsor	Collaborator
DBL -Institute for Health Research and Development

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost of different treatment arm	Cost of different treatment arm	May-October 2016 (5 months)
Primary	Effect of Mass drug administration on prevalence and intensity of Schistosoma mansoni among children and adults	Prevalence and intensity of Schistosoma mansoni	May -October 2016 (5 months)
Secondary	Mass drug administration coverage	Coverage of treatment	May -October 2016 (5 months)