Schistosoma Mansoni Morbidity in Children Aged 1-5 Years | NCT01901484

Studies
Schistosoma Mansoni Morbidity in Children Aged 1-5 Years

NCT01901484

Sponsor

Makerere University

Status

Completed

Last Update Posted

Sep 17, 2014Estimated

Enrollment

800Estimated

Phase

Phase 2

Conditions

Intestinal Schistosomiasis

Interventions

Praziquantel

Countries

Uganda

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

May 30, 2013

First Submission Date that Met QC Criteria

Jul 12, 2013

First Posted Date

Jul 17, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2014

Last Update Posted Date

Sep 17, 2014Estimated

Name	Class
University of Copenhagen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drug: Praziquantel	Active Comparator	Praziquantel 40mg/Kg - single dose	Drug: Praziquantel
Praziquantel	Active Comparator	double dose	Drug: Praziquantel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1-5 years

Exclusion Criteria:

<1-5> years

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Allen Nalugwa, PhD	CHDC-Makerere University	Principal Investigator
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	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Child Health & Development Centre, College of Health Sciences , Makerere University		Kampala		6717	Uganda

Condition Browse Module

MeSH Terms

ID	Term
D012555	Schistosomiasis mansoni
D012552	Schistosomiasis

Ancestor Terms

ID	Term
D014201	Trematode Infections
D006373	Helminthiasis
D010272	Parasitic Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011223	Praziquantel

Ancestor Terms

ID	Term
D007546	Isoquinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided