CompletedNot Applicable

Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania

Romania1,234 participantsStarted 2008-02

Plain-language summary

The purpose of this hospital based study is to estimate the proportion of rotavirus gastroenteritis in children \< 5 years of age in Romania.

Who can participate

Age range

5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * A male or female child aged \< 5 years at the time of admission. A child becomes ineligible on the day of her/his fifth birthday. * A subject, who during the study period: * Is hospitalised for acute gastroenteritis Or * Visits an emergency room for acute gastroenteritis Or * Has rotavirus positive laboratory results and develops acute gastroenteritis at least 48 hours after hospitalisation Exclusion Criteria: Not applicable

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of rotavirus gastroenteritis among all acute gastroenteritis hospitalisations of children < 5 years of age

Timeframe: At least 12 months from study start

Proportion of rotavirus gastroenteritis among all acute gastroenteritis emergency room visits for children < 5 years of age

Timeframe: At least 12 months from study start

Incidence of medical care associated rotavirus gastroenteritis among all hospitalised children < 5 years of age

Timeframe: At least 12 months from study start

Trial details

NCT IDNCT01253967

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-01

View on ClinicalTrials.gov More Infections, Rotavirus trials

Who can participate

Age range

5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Proportion of rotavirus gastroenteritis among all acute gastroenteritis hospitalisations of children < 5 years of age

Timeframe: At least 12 months from study start

Proportion of rotavirus gastroenteritis among all acute gastroenteritis emergency room visits for children < 5 years of age

Timeframe: At least 12 months from study start

Incidence of medical care associated rotavirus gastroenteritis among all hospitalised children < 5 years of age

Timeframe: At least 12 months from study start