Schistosoma Mansoni in Mwanza Region, Tanzania (SCORE_PAR)

DBL -Institute for Health Research and Development

Status: Completed

Conditions: Schistosoma Mansoni

Treatments: Drug: Praziquantel

Study type: Interventional

Funder types: Other

Identifiers

NCT02162875

BMGF (Other Grant/Funding Number)

TAN-score

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37,500 estimated patients

Sex: All

Ages: 7 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37,500 participants in 6 patient groups

MDA once a year

Experimental group

Description:

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

Treatment:

Drug: Praziquantel

MDA 2nd year CWT follwed by 2 years SBT

Experimental group

Description:

Treatment with praziquantel as arm 1 given by two years of community wide treatment (CWT) followed by two years of school-based treatment (SBT)

Treatment:

Drug: Praziquantel

Praziquantel every second year CWT

Experimental group

Description:

Treatment with praziquantel given every second year as CWT

Treatment:

Drug: Praziquantel

MDA once a year SBT

Experimental group

Description:

Treatment with praziquantel as above given as 4 years of SBT

Treatment:

Drug: Praziquantel

MDA given for 2 years as SBT

Experimental group

Description:

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

Treatment:

Drug: Praziquantel

MDA as SBT 1year and 1 year without MDA

Experimental group

Description:

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

Treatment:

Drug: Praziquantel