Respiratory InfectionINHALENCT05904223
Effect of IN Hospital PCR Based Assessment of Patients With Lower Respiratory Tract Infections on LEngth of Stay
A study testing Respiratory Panel PCR Sputum in people with Respiratory Infection, run by Alexander Zoufaly at 1 site in Austria.
Trial summary
Does the use of the BIOFIRE® FILMARRAY® Pneumonia Panel plus in hospitalized patients with lower respiratory infections lead to a reduction in length of hospital stay (LOS) and customized antibiotic treatment (higher amount of specific vs empiric treatment, shorter treatment duration, less antibiotic treatment, lower… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Infection
- What is being tested?
- Respiratory Panel PCR Sputum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteAustria
- Study dates
- 10 May 2023to Dec 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Hospitalised patients on a general ward
- Ability to give consent
- Ability to produce sputum
- AND (one of the following diagnosis)
- acute exacerabation of COPD (defined as known COPD and worsening of symptoms like dyspnea +/- wheezing +/- increased sputum purulence and the need for additional treatment)
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- Pneumonia (diagnosed via chest X-ray)
- OR
- Lower respiratory infection (which does not belong to one of the two former diagnosis) with following symptoms:
- At least one criterion Cough (more than usual if smoker) Dyspnea Increased sputum purulence
- AND (at least one criterion) Respiratory rate ≥22/min Reduced oxygen saturation (<95%) (or worsening of oxygen saturation by 3% (e.g. in patients with COPD) Fever (temp >38°C) Rales/wheezing Chest pain upon breathing
Who cannot join
- Other proven or suspected systemic diseases which require antibiotic treatment, like:
- Intraabdominal infections (appendicitis, cholecystitis, diverticulitis, peritonitis)
- C. difficile associated diarrhea (only if existing on admission otherwise it will be identified as a side effect)
- Urinary tract infections like pyelonephritis, urosepsis, cystitis + fever (asymptomatic bacteriuria is NOT an exclusion criterion)
- Acute bacterial skin and skin structure infections (erysipelas, abscess with systemic symptoms, diabetic foot infection, osteomyelitis)
- Another single cause which can explain the respiratory symptoms better than an infection (acute heart failure, pulmonary embolism, hypertension induced lung edema)
Show all 10Show fewer
- Proven respiratory infection via another PCR based system (e.g. influenza or tuberculosis)
- Inability to give consent
- Inability to produce sputum
- Moribund and palliative patients
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Klinik Favoriten
Vienna, Österreich, 1100
Klaus Breinbauer, Dr. med., +4316019172454, klaus.breinbauer@gesundheitsverbund.at
About this study
Official title: Effect of IN Hospital PCR Based Assessment of Patients With Lower Respiratory Tract Infections on LEngth of Stay - INHALE Trial
Does the use of the BIOFIRE® FILMARRAY® Pneumonia Panel plus in hospitalized patients with lower respiratory infections lead to a reduction in length of hospital stay (LOS) and customized antibiotic treatment (higher amount of specific vs empiric treatment, shorter treatment duration, less antibiotic treatment, lower incidence of side effects) compared to the standard of care?
Read the detailed description
Lower respiratory tract infections (LRTIs) like pneumonia, exacerbations of COPD or bronchitis are caused by several viral and/or bacterial pathogens. Even in huge epidemiological studies the causative pathogen can just be detected in approximately 50% of pneumonia cases. In clinical practice the pathogen is only known in few cases, e.g. Legionella via urine antigen test. It is impossible to distinguish the triggering bacteria by clinical parameters and even accurate differentiation between bacterial and viral infections is often not possible. The same problem exists for other LRTIs.
The lack of knowledge of the causative pathogen leads to several problems:
First, clinicians tend to observe patients after treatment initiation for a longer period than probably necessary, which may lead to an increased length of hospital stay. Secondly, the antibiotic treatment has to be broad enough to cover all possible pathogens empirically. This might lead to an overuse of broad-spectrum antibiotics, an increased risk of side effects, the development of antibiotic resistance or even delayed treatment of the causative agent. Finally, antibiotics are prescribed erroneously for viral infections, which have been misinterpreted as bacterial infections by clinicians.
The BIOFIRE® FILMARRAY® Pneumonia Panel plus can help to solve these problems by identifying the causative pathogen in LRTIs within 1.5 hours. The decision of the treatment and its duration would be pathogen driven and no longer just empirically based on a lot of unknown factors.
The investigators would like to perform the following study with two groups: standard of care (control group) vs Pneumonia panel plus (intervention group). Both groups will receive the standard of care treatment but the intervention group will additionally have their sputum analyzed via the BIOFIRE® FILMARRAY® Pneumonia Panel plus.
Additional information empiric vs specific treatment:
- empiric therapy - every antimicrobial therapy prescribed without knowing the pathogen
- Amoxicillin/Clavulanic acid or Cefuroxime or Ceftriaxone/Cefotaxime or Piperacillin/Tazobactam or Levofloxacin
- Specific therapy - pathogen driven, prescribed knowing the pathogen; narrowed spectrum of agent
- Pneumococcus - Penicillin G
- H. influenzae - Cefuroxime or Doxycycline
- Moraxella - Cefuroxime or Doxycycline
- MSSA - Cefazolin or Flucloxacillin
- MRSA - Linezolid or Vancomycin
- Pseudomonas - Ceftazidime
- E. coli - Cefuroxime or third generation Cephalosporin or Ciprofloxacin
- Klebsiella - Cefuroxime or third generation Cephalosporin or Ciprofloxacin
- Proteus, Serratia - third generation Cephalosporin or Ciprofloxacin
- Enterobacter cloacae - Ertapenem
- Legionella - Levofloxacin or Azithromycin
- Mycoplasma - Azithromycin or Doxycycline
- In case of ESBLs - Ertapenem or Meropenem
- In case of carbapenemases - Ceftazidime/Avibactam (OXA48, KPC) or Meropenem/Vaborbactam (KPC) or Aztreonam +/- Ceftazidime/Avibactam (MBL +- others)
- Conditions
- Respiratory Infection
- Being tested
- Respiratory Panel PCR Sputum
- Keywords
- Biofire
- 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.
Respiratory Panel PCR SputumDiagnostic test
Multiplex PCR Respiratory Panel from Biomerieux used on Patients Sputum
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | standard of care (SOC) group = control group: * Routine laboratory parameters (CBC, CRP, kidney and liver parameters, etc.) on the day of admission and when clinically necessary - decision is made by the physician in charge * Sputum microscopy for quality assessment (via Bartlett score) * Chest X-ray on the day of admission or the day after * 2 Sets of blood cultures (if temperature >38°) * Pneumococcus urine antigen test for every patient with proven or suspected pneumonia * Legionella urine antigen test for every patient with proven or suspected pneumonia and clinical suspicion for Legionella infection (travel history, air condition, elevated CK, hyponatremia, reduced kidney function) * Antibiotic treatment if deemed necessary by the treating physician |
| Standard of Care + Respiratory Panel | Experimental | Pneumonia panel plus group = intervention group
* Sputum analysis via the BIOFIRE® FILMARRAY® Pneumonia Panel plus
* Routine laboratory parameters (CBC, CRP, kidney and liver parameters, etc.) on the day of admission and when clinically necessary - decision is made by the physician in charge
* Sputum microscopy for quality assessment (via Bartlett score)
* Chest X-ray on the day of admission or the day after
* 2 Sets of blood cultures
* Pneumococcus urine antigen test for every patient with proven or suspected pneumonia
* Legionella urine antigen test for every patient with proven or suspected pneumonia and
* Antibiotic treatment if deemed necessary by the treating physician Receives: Diagnostic Test: Respiratory Panel PCR Sputum |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay (LOS) in days
How long is the lenght of stay in days (half-days)?
Measured: From admission to discharge or death, whichever comes first, assessed up to 12 Months
Secondary outcomes (6)
Duration of antibiotic treatment needed represented as days of treatment (DOT)
How long is the duration of antibiotic treatment in days?
Measured: From start of antibiotic treatment to discontinuation of any cause, assessed up to 12 Months
Number of usage of specific vs empiric antibiotic treatment
Is there a difference in used antibiotic treatment?
Measured: From start of antibiotic treatment to discontinuation of any cause, assessed up to 12 Months
Cost of antibiotic treatment
Is there a differnece in cost of antibiotic treatment?
Measured: From start of antibiotic treatment to discontinuation of any cause, assessed up to 12 Months
In hospital and 30-day mortality
Is there a difference in 30-day mortality?
Measured: From admission to death or 30 days after admission
C. difficile associated diarrhea within 30-day-follow-up
Is there a diference in incidence of C. difficile associated diarrhea?
Measured: From admission to death or 30 days after admission
30-day re-admission rate
Is there a difference in 30-day re-admission rate?
Measured: From admission to death or 30 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start10 May 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexander Zoufaly
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux
- Responsible party
- Sponsor-investigator, Alexander Zoufaly, Klinik Favoriten
- Investigators
- Alexander Zoufaly, Prof. Dr., Principal investigator, Klinik Favoriten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904223
- Sponsor's protocol ID
- INHALE
- Acronym
- INHALE
- Status last verified
- Jun 2023
- First submitted
- 23 May 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of IN Hospital PCR Based Assessment of Patients With Lower Respiratory Tract Infections on LEngth of Stay - INHALE Trial
- ClinicalTrials.gov ID
- NCT05904223
- Acronym / sponsor ID
- INHALE / INHALE
- Conditions
- Respiratory Infection
- Keywords
- Biofire
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- Alexander ZoufalyUniversity, hospital or other
- Collaborators
- BioMérieux
- Study start
- 10 May 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Jun 2023 (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.
Does the use of the BIOFIRE® FILMARRAY® Pneumonia Panel plus in hospitalized patients with lower respiratory infections lead to a reduction in length of hospital stay (LOS) and customized antibiotic treatment (higher amount of specific vs empiric treatment, shorter treatment duration, less antibiotic treatment, lower incidence of side effects) compared to the standard of care?
Detailed description
Lower respiratory tract infections (LRTIs) like pneumonia, exacerbations of COPD or bronchitis are caused by several viral and/or bacterial pathogens. Even in huge epidemiological studies the causative pathogen can just be detected in approximately 50% of pneumonia cases. In clinical practice the pathogen is only known in few cases, e.g. Legionella via urine antigen test. It is impossible to distinguish the triggering bacteria by clinical parameters and even accurate differentiation between bacterial and viral infections is often not possible. The same problem exists for other LRTIs.
The lack of knowledge of the causative pathogen leads to several problems:
First, clinicians tend to observe patients after treatment initiation for a longer period than probably necessary, which may lead to an increased length of hospital stay. Secondly, the antibiotic treatment has to be broad enough to cover all possible pathogens empirically. This might lead to an overuse of broad-spectrum antibiotics, an increased risk of side effects, the development of antibiotic resistance or even delayed treatment of the causative agent. Finally, antibiotics are prescribed erroneously for viral infections, which have been misinterpreted as bacterial infections by clinicians.
The BIOFIRE® FILMARRAY® Pneumonia Panel plus can help to solve these problems by identifying the causative pathogen in LRTIs within 1.5 hours. The decision of the treatment and its duration would be pathogen driven and no longer just empirically based on a lot of unknown factors.
The investigators would like to perform the following study with two groups: standard of care (control group) vs Pneumonia panel plus (intervention group). Both groups will receive the standard of care treatment but the intervention group will additionally have their sputum analyzed via the BIOFIRE® FILMARRAY® Pneumonia Panel plus.
Additional information empiric vs specific treatment:
- empiric therapy - every antimicrobial therapy prescribed without knowing the pathogen
- Amoxicillin/Clavulanic acid or Cefuroxime or Ceftriaxone/Cefotaxime or Piperacillin/Tazobactam or Levofloxacin
- Specific therapy - pathogen driven, prescribed knowing the pathogen; narrowed spectrum of agent
- Pneumococcus - Penicillin G
- H. influenzae - Cefuroxime or Doxycycline
- Moraxella - Cefuroxime or Doxycycline
- MSSA - Cefazolin or Flucloxacillin
- MRSA - Linezolid or Vancomycin
- Pseudomonas - Ceftazidime
- E. coli - Cefuroxime or third generation Cephalosporin or Ciprofloxacin
- Klebsiella - Cefuroxime or third generation Cephalosporin or Ciprofloxacin
- Proteus, Serratia - third generation Cephalosporin or Ciprofloxacin
- Enterobacter cloacae - Ertapenem
- Legionella - Levofloxacin or Azithromycin
- Mycoplasma - Azithromycin or Doxycycline
- In case of ESBLs - Ertapenem or Meropenem
- In case of carbapenemases - Ceftazidime/Avibactam (OXA48, KPC) or Meropenem/Vaborbactam (KPC) or Aztreonam +/- Ceftazidime/Avibactam (MBL +- others)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –standard of care (SOC) group = control group: * Routine laboratory parameters (CBC, CRP, kidney and liver parameters, etc.) on the day of admission and when clinically necessary - decision is made by the physician in charge * Sputum microscopy for quality assessment (via Bartlett score) * Chest X-ray on the day of admission or the day after * 2 Sets of blood cultures (if temperature >38°) * Pneumococcus urine antigen test for every patient with proven or suspected pneumonia * Legionella urine antigen test for every patient with proven or suspected pneumonia and clinical suspicion for Legionella infection (travel history, air condition, elevated CK, hyponatremia, reduced kidney function) * Antibiotic treatment if deemed necessary by the treating physician |
| Standard of Care + Respiratory Panel | Experimental | Diagnostic Test: Respiratory Panel PCR SputumPneumonia panel plus group = intervention group * Sputum analysis via the BIOFIRE® FILMARRAY® Pneumonia Panel plus * Routine laboratory parameters (CBC, CRP, kidney and liver parameters, etc.) on the day of admission and when clinically necessary - decision is made by the physician in charge * Sputum microscopy for quality assessment (via Bartlett score) * Chest X-ray on the day of admission or the day after * 2 Sets of blood cultures * Pneumococcus urine antigen test for every patient with proven or suspected pneumonia * Legionella urine antigen test for every patient with proven or suspected pneumonia and * Antibiotic treatment if deemed necessary by the treating physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years
- Hospitalised patients on a general ward
- Ability to give consent
- Ability to produce sputum
- AND (one of the following diagnosis)
Key exclusion criteria (10 listed)
- Other proven or suspected systemic diseases which require antibiotic treatment, like:
- Proven respiratory infection via another PCR based system (e.g. influenza or tuberculosis)
- Inability to give consent
- Inability to produce sputum
- Moribund and palliative patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory Panel PCR SputumMultiplex PCR Respiratory Panel from Biomerieux used on Patients Sputum | Diagnostic test | Standard of Care + Respiratory Panel |
Primary outcome
length of stay (LOS) in days
Time frame: From admission to discharge or death, whichever comes first, assessed up to 12 Months
How long is the lenght of stay in days (half-days)?
6 secondary outcomes
Duration of antibiotic treatment needed represented as days of treatment (DOT)
Time frame: From start of antibiotic treatment to discontinuation of any cause, assessed up to 12 Months
Number of usage of specific vs empiric antibiotic treatment
Time frame: From start of antibiotic treatment to discontinuation of any cause, assessed up to 12 Months
Cost of antibiotic treatment
Time frame: From start of antibiotic treatment to discontinuation of any cause, assessed up to 12 Months
In hospital and 30-day mortality
Time frame: From admission to death or 30 days after admission
C. difficile associated diarrhea within 30-day-follow-up
Time frame: From admission to death or 30 days after admission
30-day re-admission rate
Time frame: From admission to death or 30 days after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Alexander Zoufaly, Prof. Dr. principal investigator
Klinik Favoriten
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Panel PCR Sputum in people with Respiratory Infection, run by Alexander Zoufaly at 1 site in Austria.
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 11 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Klaus Breinbauer, Dr. med. (+43 1 60191 72454, klaus.breinbauer@gesundheitsverbund.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of stay (LOS) in days (time frame: From admission to discharge or death, whichever comes first, assessed up to 12 Months). 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 3 Jul 2023.