NCT02162875

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 13, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

5.8 years

First QC Date

May 26, 2014

Last Update Submit

February 9, 2017

Conditions

Keywords

Schistosoma mansonitreatmentschool childrenadults

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Mass drug administration coverage

    May -October 2016 (5 months)

Other Outcomes (1)

  • Cost of different treatment arm

    May-October 2016 (5 months)

Study Arms (6)

MDA once a year

EXPERIMENTAL

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

Drug: Praziquantel

MDA 2nd year CWT follwed by 2 years SBT

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)

Drug: Praziquantel

Praziquantel every second year CWT

EXPERIMENTAL

Treatment with praziquantel given every second year as CWT

Drug: Praziquantel

MDA once a year SBT

EXPERIMENTAL

Treatment with praziquantel as above given as 4 years of SBT

Drug: Praziquantel

MDA given for 2 years as SBT

EXPERIMENTAL

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

Drug: Praziquantel

MDA as SBT 1year and 1 year without MDA

EXPERIMENTAL

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

Drug: Praziquantel

Interventions

Six different treatment strategies with praziquantel

Also known as: no other drugs
MDA 2nd year CWT follwed by 2 years SBTMDA as SBT 1year and 1 year without MDAMDA given for 2 years as SBTMDA once a yearMDA once a year SBTPraziquantel every second year CWT

Eligibility Criteria

Age7 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Mediacal Research

Mwanza, Kagera, Tanzania

Location

MeSH Terms

Conditions

Schistosomiasis

Interventions

Praziquantel

Condition Hierarchy (Ancestors)

Trematode InfectionsHelminthiasisParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Safari Kinung'hi, PhD

    National Institute for Medical Research, Mwanza Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 26, 2014

First Posted

June 13, 2014

Study Start

March 1, 2011

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 10, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations