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Schistosoma Mansoni Morbidity in Children Aged 1-5 Years

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ClinicalTrials.gov Identifier: NCT01901484
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : September 17, 2014
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Allen Nalugwa, Makerere University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Presence/absence of organomegaly at Day 0 and 8 months follow-up visits [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Cure rate at 30 days after treatment [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1-5 years

Exclusion Criteria:

<1-5> years


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901484


Locations
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Uganda
Child Health & Development Centre, College of Health Sciences , Makerere University
Kampala, Uganda, 6717
Sponsors and Collaborators
Makerere University
University of Copenhagen
Investigators
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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
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Responsible Party: Allen Nalugwa, Doctor, Makerere University
ClinicalTrials.gov Identifier: NCT01901484    
Other Study ID Numbers: 2012162
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014
Keywords provided by Allen Nalugwa, Makerere University:
Schistosoma mansoni
morbidity
chemotherapy
Additional relevant MeSH terms:
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Schistosomiasis
Schistosomiasis mansoni
Trematode Infections
Helminthiasis
Parasitic Diseases
Praziquantel
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents