Schistosoma Mansoni Morbidity in Children Aged 1-5 Years

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intestinal Schistosomiasis

Intervention / Treatment
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* Drug: Praziquantel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1-5 years Exclusion Criteria: <1-5> years

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug: Praziquantel<br>Praziquantel 40mg/Kg - single dose | Drug: Praziquantel<br>* 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.<br>|
| Active Comparator: Praziquantel<br>double dose | Drug: Praziquantel<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of organomegaly at Day 0 and 8 months follow-up visits |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate at 30 days after treatment |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schistosoma mansoni, morbidity, chemotherapy