Study to Estimate the Disease Burden of Acute Rotavirus G... | NCT01201252

Studies
Study to Estimate the Disease Burden of Acute Rotavirus Gastroenteritis in Children < 5 Years in United Arab Emirates

NCT01201252

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Nov 19, 2012Estimated

Enrollment

717Actual

Phase

Not provided

Conditions

Rotaviral Gastroenteritis

Interventions

Stool sampling

Countries

United Arab Emirates

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

Nov 2012

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

Jul 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Sep 13, 2010

First Submission Date that Met QC Criteria

Sep 13, 2010

First Posted Date

Sep 14, 2010Estimated

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

Nov 15, 2012

Last Update Posted Date

Nov 19, 2012Estimated

Description Module

Brief Summary

The purpose of this study is to estimate the disease burden and epidemiology of rotavirus gastroenteritis in children less than 5 years of age, in United Arab Emirates. Acute gastroenteritis cases will be identified from acute gastroenteritis hospitalisation log book and stool samples will be collected from all suspected and confirmed acute gastroenteritis cases.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

717Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acute gastroenteritis Group		Suspected/confirmed cases of rotavirus gastroenteritis in children < 5 years of age	Procedure: Stool sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stool sampling	Procedure	Stool samples will be collected, tested and genotyped for the presence of rotavirus	Acute gastroenteritis Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of diarrhoeal hospitalisations in children < 5 years of age, which are attributable to rotavirus.		Twelve months from study initiation

Secondary Outcomes

Measure	Description	Time Frame
Age and seasonal distribution of hospitalisations associated with rotavirus in children < 5 years of age.		Twelve months from study initiation
Occurrence of intravenous re-hydration treatment and/or other treatments due to rotavirus gastroenteritis.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A male or female < 5 years of age at the time of admission to the study hospital for acute gastroenteritis.
Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

The diagnosis for treatment at the study site does not include acute gastroenteritis.
The onset of acute gastroenteritis after admission to the hospital i.e. 48 hours after hospital admission.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

5 Years

Standard Ages

Child

Study Population

Children < 5 years of age hospitalised with acute gastroenteritis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Abu Dhabi			United Arab Emirates
GSK Investigational Site

Condition Browse Module

MeSH Terms

ID	Term
D005759	Gastroenteritis

Ancestor Terms

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided