Schistosoma Mansoni Morbidity in Children Aged 1-5 Years

Phase 2

Completed

• Conditions: Intestinal Schistosomiasis
• Interventions: Drug: Praziquantel

• Registration Number: NCT01901484
• Lead Sponsor: Makerere University

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.

Detailed Description

The study has three phases: in the first phase (Phase I) a baseline pretreatment schistosomiasis morbidity assessment of children aged 1-5 years will take place. The Kato-Katz technique will be used to detect and enumerate S. mansoni eggs in faecal samples from each participating child. Communities with the highest S. mansoni prevalence and intensity will be chosen and included in the study. In the second phase (Phase II) the S. mansoni positive children will be divided randomly into two intervention groups, single and double dose praziquantel treatment arms. Abdominal ultrasound will be combined with clinical examination to accurately identify hepatosplenomegaly. The sizes of both the liver and spleen will be examined. Anthropometric measurements and Hb for each child will also be recorded. In the last phase (Phase III), the effect of praziquantel on S. mansoni morbidity will be evaluated in all the treated children aged 1-5 years.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-05-30
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-17
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1-5 years

Read More

Exclusion Criteria

<1-5> years

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: Praziquantel	Praziquantel	Praziquantel 40mg/Kg - single dose
Praziquantel	Praziquantel	double dose

Primary Outcome Measures

Name	Time	Method
Presence/absence of organomegaly at Day 0 and 8 months follow-up visits	2 years

Secondary Outcome Measures

Name	Time	Method
Cure rate at 30 days after treatment	2 years

Trial Locations

Locations (1)

Child Health & Development Centre, College of Health Sciences , Makerere University; 🇺🇬 Kampala, Uganda