NCT01901484

Brief Summary

This study is about intestinal schistosomiasis, commonly known as bilharzia, in children aged 1-5 years along Lake Victoria shoreline.The children will be screened for S. mansoni and the effects of the disease will be assessed.Children found positive with S. mansoni will be treated with praziquantel and followed up for a year.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

1.2 years

First QC Date

May 30, 2013

Last Update Submit

September 16, 2014

Conditions

Intestinal Schistosomiasis

Keywords

Schistosoma mansonimorbiditychemotherapy

Outcome Measures

Primary Outcomes (1)

  • Presence/absence of organomegaly at Day 0 and 8 months follow-up visits

    2 years

Secondary Outcomes (1)

  • Cure rate at 30 days after treatment

    2 years

Study Arms (2)

Drug: Praziquantel

ACTIVE COMPARATOR

Praziquantel 40mg/Kg - single dose

Drug: Praziquantel

Praziquantel

ACTIVE COMPARATOR

double dose

Drug: Praziquantel

Interventions

PraziquantelDRUG

All the registered S. mansoni infected children aged 1-5 years will be randomly divided into two treatment arms: single and double dose. A second those will be administered after two weeks following the last treatment.

Drug: PraziquantelPraziquantel

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years

You may not qualify if:

  • \<1-5\> years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Health & Development Centre, College of Health Sciences , Makerere University

Kampala, 6717, Uganda

Location

MeSH Terms

Conditions

Schistosomiasis mansoniSchistosomiasis

Interventions

Praziquantel

Condition Hierarchy (Ancestors)

Trematode InfectionsHelminthiasisParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Allen Nalugwa, PhD

    CHDC-Makerere University

    PRINCIPAL INVESTIGATOR

  • Annette Olsen, PhD

    University of Copenhagen

    STUDY DIRECTOR

  • Edridah Muheki, PhD

    Ministry of Health, Vector Control Division

    STUDY DIRECTOR

  • Fred Nuwaha, PhD

    School of Public Health, Makerere University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 30, 2013

First Posted

July 17, 2013

Study Start

December 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

UG(1)