Schistosoma Mansoni Morbidity in Children Aged 1-5 Years

Intestinal Schistosomiasis Clinical Trial

Official title:

Intestinal Schistosomiasis in Children Aged 1-5 Years,Morbidity Assessment and the Effect of Praziquantel on Morbidity; Along Lake Victoria Shorelines.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901484
• Other study ID #: 2012162
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2013
• Last updated: September 16, 2014
• Start date: December 2012
• Est. completion date: February 2014

Study information

• Verified date: September 2014
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 5 Years

Eligibility

Inclusion Criteria:

1-5 years

Exclusion Criteria:

<1-5> years

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intestinal Schistosomiasis
• Schistosomiasis
• Schistosomiasis mansoni

Intervention

Drug:
• Praziquantel
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.

Locations

Country	Name	City	State
Uganda	Child Health & Development Centre, College of Health Sciences , Makerere University	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
Makerere University	University of Copenhagen

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence/absence of organomegaly at Day 0 and 8 months follow-up visits		2 years	Yes
Secondary	Cure rate at 30 days after treatment		2 years	Yes