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Respiratory Tract InfectionsNCT03574532

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)

An observational study of Respiratory Tract Infections, run by Janssen-Cilag International NV at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Respiratory Tract Infections
How many people
118 participants
Where
2 sitesin 2 countries
Study dates
27 Jun 2018to 21 Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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).

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Germany1 site
  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

Spain1 site
  • Hosp. Univ. de La Princesa

    Madrid, 28006

Other trials in Spain

About this study

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

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).

Medical subject headings
Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03574532
Study groupRoleWhat they receive
Hospitalized adults with RSV, hMPV and influenza A infectionsRespiratory 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 infectionRespiratory 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 6 months after discharge

Secondary outcomes (21)
  1. 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.

    Measured: During hospitalization (up to maximum 12 months)

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

    Number of infants/children participants with RSV and hMPV infection will be reported.

    Measured: During hospitalization (up to maximum 12 months)

  3. 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.

    Measured: During hospitalization (up to maximum 12 months)

  4. 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.

    Measured: At admission (Day 1) and at discharge

  5. 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.

    Measured: During hospitalization (up to maximum 12 months)

  6. 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.

    Measured: During hospitalization (up to maximum 12 months)

  7. 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.

    Measured: During hospitalization and up to 6 months after discharge

  8. 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.

    Measured: At admission, at ICU admission, at discharge (up to maximum 12 months)

  9. 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.

    Measured: Baseline, Day 4, Day 6 and Day 14

  10. 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.

    Measured: At admission (Day 1), Day 3, and Day 6

  11. 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.

    Measured: At admission (Day 1)

  12. 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.

    Measured: At ICU admission (up to maximum 12 months)

  13. 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.

    Measured: At ICU admission (up to maximum 12 months)

  14. 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.

    Measured: Baseline

  15. 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.

    Measured: Baseline

  16. 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.

    Measured: At Admission (Day 1)

  17. Levels of White Blood cell During Hospitalization

    Levels of White Blood cell Count during hospitalization will be reported.

    Measured: During hospitalization (up to maximum 12 months)

  18. Levels of Neutrophils During Hospitalization

    Levels of Neutrophils during hospitalization will be reported.

    Measured: During hospitalization (up to maximum 12 months)

  19. Levels of Procalcitonin During Hospitalization

    Levels of Procalcitonin during hospitalization will be reported.

    Measured: During hospitalization (up to maximum 12 months)

  20. Levels of C-Reactive Protein During Hospitalization

    Levels of C-Reactive Protein during hospitalization will be reported.

    Measured: During hospitalization (up to maximum 12 months)

  21. Levels of Viral Load During Hospitalization

    Levels of Viral Load during hospitalization will be reported.

    Measured: During hospitalization (up to maximum 12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2018
  2. Study start27 Jun 2018
  3. Primary completion21 Jan 2019
  4. Study completion21 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03574532
Sponsor's protocol ID
CR108444
Other IDs
NOPRODRSV4001
Status last verified
Feb 2021
First submitted
21 Jun 2018
Last updated
2 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Tract Infections, run by Janssen-Cilag International NV at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Burden as Measured by Medical Resource Utilization, Complications, Mortality, Re-hospitalizations and Post Discharge Care Information (time frame: Up to 6 months after discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.

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