Clinical trial NCT03574532: 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)
Official title: A Retrospective Non-Interventional Study to Determine the Epidemiology and Evaluate the Burden of Disease in Respiratory Syncytial Virus/Human Metapneumovirus and Influenza A Infected Hospitalized Patients (Adults and Children) at Selected European Sites
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Infections
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2018-07-02
Enrollment: 118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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).


Eligibility criteria: 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

Primary outcomes:
measure: Burden as Measured by Medical Resource Utilization, Complications, Mortality, Re-hospitalizations and Post Discharge Care Information
timeFrame: Up to 6 months after discharge
Secondary outcomes:
measure: Number of Participants (Adults) with RSV, Influenza A and hMPV Infections
timeFrame: During hospitalization (up to maximum 12 months)
measure: Number of Participants (infants/children) with RSV and hMPV Infection
timeFrame: During hospitalization (up to maximum 12 months)
measure: Number of Participants in Various Subgroups of Hospitalized Patients by Type of Respiratory Pathogen
timeFrame: During hospitalization (up to maximum 12 months)
measure: Symptoms of Participants Presenting at Hospital
timeFrame: At admission (Day 1) and at discharge
measure: Number of Participants Without Presenting Symptoms of Acute Respiratory Tract Infection (ARTI)
timeFrame: During hospitalization (up to maximum 12 months)
measure: Number of Participants with Respiratory Infections of Nosocomial Origin With or Without Presenting Symptoms
timeFrame: During hospitalization (up to maximum 12 months)
measure: Patient Journey
timeFrame: During hospitalization and up to 6 months after discharge
measure: Criteria Applied for the Index-Hospitalization, Transfer to ICU, Discharge From Hospital
timeFrame: At admission, at ICU admission, at discharge (up to maximum 12 months)
measure: Participant's Clinical Status Assessed by Hospital Recovery Scale (HRS)
timeFrame: Baseline, Day 4, Day 6 and Day 14
measure: Change of National Early Warning Score (NEWS) for Adults at Admission, Day 3, and Day 6
timeFrame: At admission (Day 1), Day 3, and Day 6
measure: CRB-65 Scoring System at Admission to the Hospital for Adults with Lung Disease and the Relevance on Medical Resource Utilization (MRU) by type of Respiratory Pathogen
timeFrame: At admission (Day 1)
measure: Acute Physiologic and Chronic Health Evaluation (APACHE II) Scores in Adults at ICU Admission and the Relevance on MRU by Type of Respiratory Pathogen
timeFrame: At ICU admission (up to maximum 12 months)
measure: Simplified Acute Physiology Scores 3 (SAPS 3) in Adults at ICU Admission and the Relevance on MRU by Type of Respiratory Pathogen
timeFrame: At ICU admission (up to maximum 12 months)
measure: Medical Resources Utilization by Type of Virus Infection
timeFrame: Baseline
measure: Medical Resources Utilization by Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline
measure: ReSVinet score used at Time of Admission to the Hospital in Infants/Children, and Relevance on MRU by Type of Respiratory Pathogen
timeFrame: At Admission (Day 1)
measure: Levels of White Blood cell During Hospitalization
timeFrame: During hospitalization (up to maximum 12 months)
measure: Levels of Neutrophils During Hospitalization
timeFrame: During hospitalization (up to maximum 12 months)
measure: Levels of Procalcitonin During Hospitalization
timeFrame: During hospitalization (up to maximum 12 months)
measure: Levels of C-Reactive Protein During Hospitalization
timeFrame: During hospitalization (up to maximum 12 months)
measure: Levels of Viral Load During Hospitalization
timeFrame: During hospitalization (up to maximum 12 months)
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Madrid
country: Spain
facility: Hosp. Univ. de La Princesa
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References: