CompletedNot Applicable

A Study to Determine the Epidemiology and Evaluate the Burden of Disease in Respiratory Syncytial Virus/Human Metapneumovirus and Influenza A Infected Hospitalized Participants (Adults and Children)

Germany, Spain118 participantsStarted 2018-06-27

Plain-language summary

The purpose of this study is to describe the clinical and economic burden in adults and infants/children less than or equal to 5 years of age by type of respiratory pathogen (respiratory syncytial virus \[RSV\], influenza A, and human metapneumovirus \[hMPV\] in adults; RSV and hMPV in infants/children) based on medical resource utilization; rate and type of complications during and after hospitalization; mortality; rate and reasons of re-hospitalization related to index hospitalization; post-discharge care information and International Classification of Diseases 9th/10th revision (ICD-9/10)/Diagnostic-related Group (DRG) codes used (distribution).

Who can participate

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: * Adult greater than or equal to (\>=) 18 years of age or infant/child less than or equal to (=\<) 5 years of age * Participants hospitalized must have documentation of a confirmed diagnosis by PCR during the prespecified recent past season(s): RSV, influenza A, or hMPV infection in adults RSV or hMPV in infants/children (The first hospitalization in the season of data collection with confirmed diagnosis by PCR is considered the index hospitalization) * Participants may include those hospitalized in the season of data collection with or without symptoms of a respiratory viral infection (including those of nosocomial origin), and/or to treat complications of viral infections, including patients admitted to the intensive care unit (ICU) * Hospitalized greater than (\>) 24 hours

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

Burden as Measured by Medical Resource Utilization, Complications, Mortality, Re-hospitalizations and Post Discharge Care Information

Timeframe: Up to 6 months after discharge

Trial details

NCT IDNCT03574532

SponsorJanssen-Cilag International NV

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-01-21

View on ClinicalTrials.gov More Respiratory Tract Infections trials

Plain-language summary

Who can participate

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.