Schistosoma Mansoni Morbidity in Children Aged 1-5 Years
Primary Purpose
Intestinal Schistosomiasis
Status
Completed
Phase
Phase 2
Locations
Uganda
Study Type
Interventional
Intervention
Praziquantel
Sponsored by
About this trial
This is an interventional treatment trial for Intestinal Schistosomiasis focused on measuring Schistosoma mansoni, morbidity, chemotherapy
Eligibility Criteria
Inclusion Criteria:
1-5 years
Exclusion Criteria:
<1-5> years
Sites / Locations
- Child Health & Development Centre, College of Health Sciences , Makerere University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Drug: Praziquantel
Praziquantel
Arm Description
Praziquantel 40mg/Kg - single dose
double dose
Outcomes
Primary Outcome Measures
Presence/absence of organomegaly at Day 0 and 8 months follow-up visits
Secondary Outcome Measures
Cure rate at 30 days after treatment
Full Information
NCT ID
NCT01901484
First Posted
May 30, 2013
Last Updated
September 16, 2014
Sponsor
Makerere University
Collaborators
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT01901484
Brief Title
Schistosoma Mansoni Morbidity in Children Aged 1-5 Years
Official Title
Intestinal Schistosomiasis in Children Aged 1-5 Years,Morbidity Assessment and the Effect of Praziquantel on Morbidity; Along Lake Victoria Shorelines.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makerere University
Collaborators
University of Copenhagen
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Schistosomiasis
Keywords
Schistosoma mansoni, morbidity, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Drug: Praziquantel
Arm Type
Active Comparator
Arm Description
Praziquantel 40mg/Kg - single dose
Arm Title
Praziquantel
Arm Type
Active Comparator
Arm Description
double dose
Intervention Type
Drug
Intervention Name(s)
Praziquantel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence/absence of organomegaly at Day 0 and 8 months follow-up visits
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Cure rate at 30 days after treatment
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1-5 years
Exclusion Criteria:
<1-5> years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Nalugwa, PhD
Organizational Affiliation
CHDC-Makerere University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Annette Olsen, PhD
Organizational Affiliation
University of Copenhagen
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Edridah Muheki, PhD
Organizational Affiliation
Ministry of Health, Vector Control Division
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fred Nuwaha, PhD
Organizational Affiliation
School of Public Health, Makerere University
Official's Role
Study Director
Facility Information:
Facility Name
Child Health & Development Centre, College of Health Sciences , Makerere University
City
Kampala
ZIP/Postal Code
6717
Country
Uganda
12. IPD Sharing Statement
Learn more about this trial
Schistosoma Mansoni Morbidity in Children Aged 1-5 Years
We'll reach out to this number within 24 hrs