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)

Respiratory Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574532
• Other study ID #: CR108444
• Secondary ID: NOPRODRSV4001
• Status: Completed
• Start date: June 27, 2018
• Est. completion date: January 21, 2019

Study information

• Verified date: February 2021
• Source: Janssen-Cilag International NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: January 21, 2019
• Est. primary completion date: January 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Tract Infections

Locations

Country	Name	City	State
Germany	Universitätsklinikum Würzburg	Würzburg
Spain	Hosp. Univ. de La Princesa	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag International NV

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants (Adults) with RSV, Influenza A and hMPV Infections	Number of Adult participants with RSV, Influenza A and hMPV Infections will be reported.	During hospitalization (up to maximum 12 months)
Secondary	Number of Participants (infants/children) with RSV and hMPV Infection	Number of infants/children participants with RSV and hMPV infection will be reported.	During hospitalization (up to maximum 12 months)
Secondary	Number of Participants in Various Subgroups of Hospitalized Patients by Type of Respiratory Pathogen	Number of participants in various subgroups (eg, comorbidities, premature infants, elderly, immunocompromised) of Hospitalized Patients by Type of Respiratory Pathogen (RSV, influenza A, and hMPV in adults and RSV and hMPV in infants/children less then or equal to (<=) 5 years of age) will be characterized.	During hospitalization (up to maximum 12 months)
Secondary	Symptoms of Participants Presenting at Hospital	Symptoms of Participants Presenting at Hospital (outpatient clinic, emergency room/emergency department [ER/ED], or general ward) and at discharge will be assessed.	At admission (Day 1) and at discharge
Secondary	Number of Participants Without Presenting Symptoms of Acute Respiratory Tract Infection (ARTI)	Number of participants without presenting symptoms among participants with PCR-confirmed RSV, influenza A, or hMPV infections of ARTI will be reported.	During hospitalization (up to maximum 12 months)
Secondary	Number of Participants with Respiratory Infections of Nosocomial Origin With or Without Presenting Symptoms	Number of participants with respiratory infections of nosocomial origin with or without presenting symptoms among participants with PCR-confirmed RSV, influenza A, or hMPV infections will be reported.	During hospitalization (up to maximum 12 months)
Secondary	Patient Journey	The number of patients admitted to different hospital-locations (ED/ER department, Ward, Outpatient clinic, ICU, Other), their provenances, the number of patients being transferred to ICU and the number of patients being thereafter re-hospitalized will be assessed.	During hospitalization and up to 6 months after discharge
Secondary	Criteria Applied for the Index-Hospitalization, Transfer to ICU, Discharge From Hospital	The distribution of the primary reasons for the index-hospitalization, the distribution of the primary reasons for ICU transfer, the distribution of the criteria used to discharge from the index-hospitalization (including hospital recovery scale (HRS) and oxygen saturation) will be assessed.	At admission, at ICU admission, at discharge (up to maximum 12 months)
Secondary	Participant's Clinical Status Assessed by Hospital Recovery Scale (HRS)	The hospital recovery scale assesses a participant's clinical status. The scale provides 6 mutually exclusive conditions ordered from best to worst: 1) not hospitalized; 2) non-ICU hospitalization, not requiring supplemental oxygen; 3) non-ICU hospitalization, requiring supplemental oxygen; 4) admitted to the ICU, not requiring invasive mechanical ventilation; 5) requiring invasive mechanical ventilation; and 6) death.	Baseline, Day 4, Day 6 and Day 14
Secondary	Change of National Early Warning Score (NEWS) for Adults at Admission, Day 3, and Day 6	The NEWS provides guidance for 3 scores: Low score (1-4) should prompt assessment by a competent registered nurse who should decide if a change to frequency of clinical monitoring or an escalation of clinical care is required; Medium score (5-6) should prompt an urgent review by a clinician skilled with competencies in the assessment of acute illness; and High score (7 or more) should prompt emergency assessment by a clinical team/critical care outreach team with critical-care competencies.	At admission (Day 1), Day 3, and Day 6
Secondary	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	Confusion, respiratory rate greater than or equal to (>=) 30/minute, low systolic less than (<) 90 millimeter of mercury (mm Hg) or diastolic less than or equal to (=<) 60 mm Hg blood pressure, age >= 65 years (CRB-65) scoring system at admission to the hospital for adults with lung disease and the relevance on MRU by type of Respiratory Pathogen will be assessed. CRB-65 Scale ranges from 0 to 4. Score 0 = Very low risk of death, Score 1 and 2 = Increased risk of death and 3 or 4 = High risk of death.	At admission (Day 1)
Secondary	Acute Physiologic and Chronic Health Evaluation (APACHE II) Scores in Adults at ICU Admission and the Relevance on MRU by Type of Respiratory Pathogen	The APACHE II is a validated severity of disease classification system. It uses a point score based on initial values of 12 routine physiologic measurements (temperature, mean arterial pressure, heart rate, respiratory rate, oxygenation, arterial pH, serum sodium, potassium, and creatinine, hematocrit, white blood cell count, Glasgow coma score), age, and previous health status to provide a general measure of severity of disease. An increasing score (range 0 to 71) is closely correlated with subsequent risk of hospital death for intensive care admissions.	At ICU admission (up to maximum 12 months)
Secondary	Simplified Acute Physiology Scores 3 (SAPS 3) in Adults at ICU Admission and the Relevance on MRU by Type of Respiratory Pathogen	The SAPS 3 consists of 20 variables: age, co-morbidities, use of vasoactive drugs before ICU admission, intrahospital location before ICU admission, and length of stay in the hospital before ICU admission, reason(s) for ICU admission, planned/unplanned ICU admission, surgical status at ICU admission, anatomic site of surgery, and presence of infection at ICU admission and place acquired, lowest estimated Glasgow coma scale, highest heart rate, lowest systolic blood pressure, highest bilirubin, highest body temperature, highest creatinine, highest leukocytes, lowest platelets, lowest hydrogen ion concentration (pH), and ventilatory support and oxygenation. Score varies from a minimum of 0 points to a maximum of 217 points. Higher scores indicate higher severity.	At ICU admission (up to maximum 12 months)
Secondary	Medical Resources Utilization by Type of Virus Infection	MRU in adults by type of virus infection (RSV A, RSV B, influenza A, influenza B, hMPV, any other virus infection if available) at baseline that is before hospitalization will be collected.	Baseline
Secondary	Medical Resources Utilization by Estimated Glomerular Filtration Rate (eGFR)	MRU in adults by eGFR at baseline that is before hospitalization will be collected. The glomerular filtration rate is an indicator of renal function and is calculated based on serum creatinine.	Baseline
Secondary	ReSVinet score used at Time of Admission to the Hospital in Infants/Children, and Relevance on MRU by Type of Respiratory Pathogen	ReSVinet scale is based on seven parameters (feeding intolerance, medical intervention, respiratory difficulty, respiratory frequency, apnoea, general condition, fever) which are assigned different values (from 0 to 3) for a total of 20 points. Higher scores indicate higher severity.	At Admission (Day 1)
Secondary	Levels of White Blood cell During Hospitalization	Levels of White Blood cell Count during hospitalization will be reported.	During hospitalization (up to maximum 12 months)
Secondary	Levels of Neutrophils During Hospitalization	Levels of Neutrophils during hospitalization will be reported.	During hospitalization (up to maximum 12 months)
Secondary	Levels of Procalcitonin During Hospitalization	Levels of Procalcitonin during hospitalization will be reported.	During hospitalization (up to maximum 12 months)
Secondary	Levels of C-Reactive Protein During Hospitalization	Levels of C-Reactive Protein during hospitalization will be reported.	During hospitalization (up to maximum 12 months)
Secondary	Levels of Viral Load During Hospitalization	Levels of Viral Load during hospitalization will be reported.	During hospitalization (up to maximum 12 months)