Overview

This trial is active, not recruiting.

Condition schistosoma mansoni
Treatment praziquantel
Sponsor DBL -Institute for Health Research and Development
Start date March 2011
End date October 2016
Trial size 37500 participants
Trial identifier NCT02162875, BMGF, TAN-score

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Community wide treatment (CWT) once a year for four years with single dose praziquantel 40mg/kg
praziquantel no other drugs
Six different treatment strategies with praziquantel
(Experimental)
Treatment with praziquantel as arm 1 given by two years of community wide treatment (CWT) followed by two years of school-based treatment (SBT)
praziquantel no other drugs
Six different treatment strategies with praziquantel
(Experimental)
Treatment with praziquantel given every second year as CWT
praziquantel no other drugs
Six different treatment strategies with praziquantel
(Experimental)
Treatment with praziquantel as above given as 4 years of SBT
praziquantel no other drugs
Six different treatment strategies with praziquantel
(Experimental)
Treatment with praziquantel as above given for 2 years as SBT followed by 2 years without MDA
praziquantel no other drugs
Six different treatment strategies with praziquantel
(Experimental)
Treatment with praziquantel given as one years of SBT alternating with one year without treatment
praziquantel no other drugs
Six different treatment strategies with praziquantel

Primary Outcomes

Measure
Effect of Mass drug administration on prevalence and intensity of Schistosoma mansoni among children and adults
time frame: May -October 2016 (5 months)

Secondary Outcomes

Measure
Mass drug administration coverage
time frame: May -October 2016 (5 months)

Eligibility Criteria

Male or female participants from 7 years up to 55 years old.

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

Additional Information

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
Principal investigator Safari Kinung'hi, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by DBL -Institute for Health Research and Development.