Schistosoma Mansoni in Mwanza Region, Tanzania

NCT ID: NCT02162875

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2017-01-31

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.

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.

Conditions

Schistosoma Mansoni

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MDA once a year

Community wide treatment (CWT) once a year for four years with single dose praziquantel 40mg/kg

Group Type: EXPERIMENTAL

Praziquantel

Intervention Type: DRUG

Six different treatment strategies with praziquantel

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)

Group Type: EXPERIMENTAL

Praziquantel

Intervention Type: DRUG

Six different treatment strategies with praziquantel

Praziquantel every second year CWT

Treatment with praziquantel given every second year as CWT

Group Type: EXPERIMENTAL

Praziquantel

Intervention Type: DRUG

Six different treatment strategies with praziquantel

MDA once a year SBT

Treatment with praziquantel as above given as 4 years of SBT

Group Type: EXPERIMENTAL

Praziquantel

Intervention Type: DRUG

Six different treatment strategies with praziquantel

MDA given for 2 years as SBT

Treatment with praziquantel as above given for 2 years as SBT followed by 2 years without MDA

Group Type: EXPERIMENTAL

Praziquantel

Intervention Type: DRUG

Six different treatment strategies with praziquantel

MDA as SBT 1year and 1 year without MDA

Treatment with praziquantel given as one years of SBT alternating with one year without treatment

Group Type: EXPERIMENTAL

Praziquantel

Intervention Type: DRUG

Six different treatment strategies with praziquantel

Interventions

Praziquantel

Six different treatment strategies with praziquantel

Intervention Type: DRUG

Other Intervention Names

no other drugs

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DBL -Institute for Health Research and Development

OTHER

Sponsor Role: lead

Responsible Party

Pascal Magnussen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Safari Kinung'hi, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute for Medical Research, Mwanza Research Centre

Locations

National Institute for Mediacal Research

Mwanza, Kagera, Tanzania

Countries

Tanzania

Other Identifiers

BMGF

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TAN-score

Identifier Type: -

Identifier Source: org_study_id