Schistosoma Mansoni Morbidity in Children Aged 1-5 Years

Sponsor

Makerere University (Other)

Overall Status

Completed

CT.gov ID

NCT01901484

Collaborator

University of Copenhagen (Other)

800

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intestinal Schistosomiasis	Drug: Praziquantel	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Drug: Praziquantel Praziquantel 40mg/Kg - single dose	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.
Active Comparator: Praziquantel double dose	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.

Arm

Intervention/Treatment

Active Comparator: Drug: Praziquantel

Praziquantel 40mg/Kg - single dose

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.

Active Comparator: Praziquantel

double dose

Drug: Praziquantel

Outcome Measures

Primary Outcome Measures

Presence/absence of organomegaly at Day 0 and 8 months follow-up visits [2 years]

Secondary Outcome Measures

Cure rate at 30 days after treatment [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

1-5 years

Exclusion Criteria:

<1-5> years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Child Health & Development Centre, College of Health Sciences , Makerere University	Kampala		Uganda	6717

Sponsors and Collaborators

Makerere University
University of Copenhagen

Investigators

Principal Investigator: Allen Nalugwa, PhD, CHDC-Makerere University
Study Director: 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