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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

About this trial

This is an interventional treatment trial for Intestinal Schistosomiasis focused on measuring Schistosoma mansoni, morbidity, chemotherapy

Eligibility Criteria

1 Year - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

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

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

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

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