SCORE_PAR: Schistosoma Mansoni in Mwanza Region, Tanzania

Sponsor

DBL -Institute for Health Research and Development (Other)

Overall Status

Completed

CT.gov ID

NCT02162875

Collaborator

(none)

37,500

Enrollment

Location

Arms

70.1

Duration (Months)

535.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Schistosoma Mansoni	Drug: Praziquantel	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

37500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MDA once a year Community wide treatment (CWT) once a year for four years with single dose praziquantel 40mg/kg	Drug: Praziquantel Six different treatment strategies with praziquantel Other Names: no other drugs
Experimental: MDA 2nd year CWT follwed by 2 years SBT Treatment with praziquantel as arm 1 given by two years of community wide treatment (CWT) followed by two years of school-based treatment (SBT)	Drug: Praziquantel Six different treatment strategies with praziquantel Other Names: no other drugs
Experimental: Praziquantel every second year CWT Treatment with praziquantel given every second year as CWT	Drug: Praziquantel Six different treatment strategies with praziquantel Other Names: no other drugs
Experimental: MDA once a year SBT Treatment with praziquantel as above given as 4 years of SBT	Drug: Praziquantel Six different treatment strategies with praziquantel Other Names: no other drugs
Experimental: MDA given for 2 years as SBT Treatment with praziquantel as above given for 2 years as SBT followed by 2 years without MDA	Drug: Praziquantel Six different treatment strategies with praziquantel Other Names: no other drugs
Experimental: MDA as SBT 1year and 1 year without MDA Treatment with praziquantel given as one years of SBT alternating with one year without treatment	Drug: Praziquantel Six different treatment strategies with praziquantel Other Names: no other drugs

Outcome Measures

Primary Outcome Measures

Effect of Mass drug administration on prevalence and intensity of Schistosoma mansoni among children and adults [May -October 2016 (5 months)]
Prevalence and intensity of Schistosoma mansoni

Secondary Outcome Measures

Mass drug administration coverage [May -October 2016 (5 months)]
Coverage of treatment

Other Outcome Measures

Cost of different treatment arm [May-October 2016 (5 months)]
Cost of different treatment arm

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute for Mediacal Research	Mwanza	Lake Region	Tanzania

Sponsors and Collaborators

DBL -Institute for Health Research and Development

Investigators

Principal Investigator: Safari Kinung'hi, PhD, National Institute for Medical Research, Mwanza Research Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pascal Magnussen, Associate Professor, DBL -Institute for Health Research and Development

ClinicalTrials.gov Identifier:

NCT02162875

Other Study ID Numbers:

TAN-score
BMGF

First Posted:

Jun 13, 2014

Last Update Posted:

Feb 10, 2017

Last Verified:

Feb 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Pascal Magnussen, Associate Professor, DBL -Institute for Health Research and Development

Additional relevant MeSH terms:

Praziquantel

Study Results

No Results Posted as of Feb 10, 2017