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Completed

NCT Number: NCT01901484

Schistosoma Mansoni Morbidity in Children Aged 1-5 Years

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.

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Key information

Conditions

Intestinal Schistosomiasis Helminthiasis Infections Parasitic Diseases Schistosomiasis Schistosomiasis mansoni Trematode Infections Vector Borne Diseases

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Child Health & Development Centre, College of Health Sciences , Makerere University

Kampala, 6717, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1-5 years

Exclusion criteria

<1-5> years

Treatment and study plan

Praziquantel

Drug

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 outcomes

  1. Presence/absence of organomegaly at Day 0 and 8 months follow-up visits

    Time frame: 2 years

Secondary outcomes

  1. Cure rate at 30 days after treatment

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Makerere University

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2013
Registry last updated
Sep 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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