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)

NCT03574532 | Completed

• 2 other identifiers: CR108444NOPRODRSV4001
• Study Type: observational
• Target: 118
• Locations: 2 countries
• Sites: 2

Brief 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).

Conditions

Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

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

  Number of participants with medical resource utilization, complications, mortality, re-hospitalizations and post discharge care information will be assessed.

  Up to 6 months after discharge

Secondary Outcomes (21)

• Number of Participants (Adults) with RSV, Influenza A and hMPV Infections

  During hospitalization (up to maximum 12 months)

• Number of Participants (infants/children) with RSV and hMPV Infection

  During hospitalization (up to maximum 12 months)

• Number of Participants in Various Subgroups of Hospitalized Patients by Type of Respiratory Pathogen

  During hospitalization (up to maximum 12 months)

• Symptoms of Participants Presenting at Hospital

  At admission (Day 1) and at discharge

• Number of Participants Without Presenting Symptoms of Acute Respiratory Tract Infection (ARTI)

  During hospitalization (up to maximum 12 months)

Study Arms (2)

Hospitalized adults with RSV, hMPV and influenza A infections

Respiratory Syncytial Virus (RSV)/Human Metapneumovirus (hMPV) and Influenza A Infected adults that required hospitalization or were infected by these viruses while being hospitalized during the prespecified recent past season(s) will be retrospectively observed to describe the proportion and burden of the different types of respiratory pathogens. The primary data source for this study will be the medical records of each participating participant.

Hospitalized infants/children with RSV or hMPV infection

Respiratory Syncytial Virus (RSV)/Human Metapneumovirus (hMPV) and Infected Infants/Children that required hospitalization or were infected by these viruses while being hospitalized during the prespecified recent past season(s) will be retrospectively observed to describe the proportion and burden of the different types of respiratory pathogens. The primary data source for this study will be the medical records of each participating participant.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population consists of participants hospitalized and had a polymerase chain reaction (PCR) confirmed respiratory infection; respiratory syncytial virus \[RSV\], influenza A, and human metapneumovirus \[hMPV\] in adults; RSV or hMPV in infants/children).

You may qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (2)

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Hosp. Univ. de La Princesa

Madrid, 28006, Spain

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 2, 2018
• Study Start: June 27, 2018
• Primary Completion: January 21, 2019
• Study Completion: January 21, 2019
• Last Updated: February 2, 2021

Record last verified: 2021-02

Locations

ES (1); DE (1)