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.
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
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).
- Conditions
- Respiratory Tract Infections
- 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 group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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)
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)
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
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)
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)
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
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)
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
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
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)
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)
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)
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
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
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)
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)
Levels of Neutrophils During Hospitalization
Levels of Neutrophils during hospitalization will be reported.
Measured: During hospitalization (up to maximum 12 months)
Levels of Procalcitonin During Hospitalization
Levels of Procalcitonin during hospitalization will be reported.
Measured: During hospitalization (up to maximum 12 months)
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)
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.
- First posted2 Jul 2018
- Study start27 Jun 2018
- Primary completion21 Jan 2019
- Study completion21 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03574532
- Acronym / sponsor ID
- CR108444
- Conditions
- Respiratory Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 21 Jan 2019 (actual)
- Study completion
- 21 Jan 2019 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Burden as Measured by Medical Resource Utilization, Complications, Mortality, Re-hospitalizations and Post Discharge Care Information
Time frame: Up to 6 months after discharge
Number of participants with medical resource utilization, complications, mortality, re-hospitalizations and post discharge care information will be assessed.
21 secondary outcomes
Number of Participants (Adults) with RSV, Influenza A and hMPV Infections
Time frame: During hospitalization (up to maximum 12 months)
Number of Participants (infants/children) with RSV and hMPV Infection
Time frame: During hospitalization (up to maximum 12 months)
Number of Participants in Various Subgroups of Hospitalized Patients by Type of Respiratory Pathogen
Time frame: During hospitalization (up to maximum 12 months)
Symptoms of Participants Presenting at Hospital
Time frame: At admission (Day 1) and at discharge
Number of Participants Without Presenting Symptoms of Acute Respiratory Tract Infection (ARTI)
Time frame: During hospitalization (up to maximum 12 months)
Number of Participants with Respiratory Infections of Nosocomial Origin With or Without Presenting Symptoms
Time frame: During hospitalization (up to maximum 12 months)
Patient Journey
Time frame: During hospitalization and up to 6 months after discharge
Criteria Applied for the Index-Hospitalization, Transfer to ICU, Discharge From Hospital
Time frame: At admission, at ICU admission, at discharge (up to maximum 12 months)
Participant's Clinical Status Assessed by Hospital Recovery Scale (HRS)
Time frame: Baseline, Day 4, Day 6 and Day 14
Change of National Early Warning Score (NEWS) for Adults at Admission, Day 3, and Day 6
Time frame: At admission (Day 1), Day 3, and Day 6
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
Time frame: At admission (Day 1)
Acute Physiologic and Chronic Health Evaluation (APACHE II) Scores in Adults at ICU Admission and the Relevance on MRU by Type of Respiratory Pathogen
Time frame: At ICU admission (up to maximum 12 months)
Simplified Acute Physiology Scores 3 (SAPS 3) in Adults at ICU Admission and the Relevance on MRU by Type of Respiratory Pathogen
Time frame: At ICU admission (up to maximum 12 months)
Medical Resources Utilization by Type of Virus Infection
Time frame: Baseline
Medical Resources Utilization by Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline
ReSVinet score used at Time of Admission to the Hospital in Infants/Children, and Relevance on MRU by Type of Respiratory Pathogen
Time frame: At Admission (Day 1)
Levels of White Blood cell During Hospitalization
Time frame: During hospitalization (up to maximum 12 months)
Levels of Neutrophils During Hospitalization
Time frame: During hospitalization (up to maximum 12 months)
Levels of Procalcitonin During Hospitalization
Time frame: During hospitalization (up to maximum 12 months)
Levels of C-Reactive Protein During Hospitalization
Time frame: During hospitalization (up to maximum 12 months)
Levels of Viral Load During Hospitalization
Time frame: During hospitalization (up to maximum 12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
2 sites in 2 countries: see every site and its status.
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.