Schistosoma Mansoni Morbidity in Children Aged 1-5 Years

NCT01901484 — Phase 2, Completed, 800 participants, Makerere University

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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.

Registry	NCT01901484
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	800 (Estimated)
Sponsor	Makerere University (Other); collaborators: University of Copenhagen
Conditions	Intestinal Schistosomiasis
Interventions	Praziquantel (Drug)
Dates	start 2012-12-01, primary completion 2014-02-01, completion 2014-02-01, first posted 2013-07-17, last updated 2014-09-17
Locations	1 site in Uganda

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Drug: Praziquantel	Active comparator	Drug: Praziquantel	Praziquantel 40mg/Kg - single dose
Praziquantel	Active comparator	Drug: Praziquantel	double dose

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.

+Outcome measures

Primary outcomes

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

Secondary outcomes

Cure rate at 30 days after treatment [2 years]

+Eligibility

Sex: All, ages: 1 Year to 5 Years, accepts healthy volunteers

Inclusion Criteria:

1-5 years

Exclusion Criteria:

<1-5> years

+Locations (1)

Facility	City	Country	Status
Child Health & Development Centre, College of Health Sciences , Makerere University	Kampala	Uganda

+Investigators

Allen Nalugwa, PhD, Principal investigator, CHDC-Makerere University
Annette Olsen, PhD, Study director, University of Copenhagen
Edridah Muheki, PhD, Study director, Ministry of Health, Vector Control Division
Fred Nuwaha, PhD, Study director, School of Public Health, Makerere University