Effect of IN Hospital PCR Based Assessment of Patients With Lower Respiratory Tract Infections on LEngth of Stay

NCT05904223 | Unknown

• 1 other identifier: INHALE
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

Brief 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 incidence of side effects) compared to the standard of care?

Conditions

Respiratory Infection

Keywords

Biofire

Outcome Measures

Primary Outcomes (1)

• length of stay (LOS) in days

  How long is the lenght of stay in days (half-days)?

  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)

  From start of antibiotic treatment to discontinuation of any cause, assessed up to 12 Months

• Number of usage of specific vs empiric antibiotic treatment

  From start of antibiotic treatment to discontinuation of any cause, assessed up to 12 Months

• Cost of antibiotic treatment

  From start of antibiotic treatment to discontinuation of any cause, assessed up to 12 Months

• In hospital and 30-day mortality

  From admission to death or 30 days after admission

• C. difficile associated diarrhea within 30-day-follow-up

  From admission to death or 30 days after admission

Study Arms (2)

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

Diagnostic Test: Respiratory Panel PCR Sputum

Interventions

Respiratory Panel PCR Sputum DIAGNOSTIC_TEST

Multiplex PCR Respiratory Panel from Biomerieux used on Patients Sputum

Standard of Care + Respiratory Panel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Pneumonia (diagnosed via chest X-ray)
• 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

You may not qualify if:

• 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)
• 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)
• 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

Sponsors & Collaborators

• Alexander Zoufaly: lead
• BioMérieux: collaborator

Study Sites (1)

Klinik Favoriten

Vienna, Österreich, 1100, Austria

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Alexander Zoufaly, Prof. Dr.

  Klinik Favoriten

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klaus Breinbauer, Dr. med.

CONTACT

+43 1 60191 72454; klaus.breinbauer@gesundheitsverbund.at

Alexander Zoufaly, Prof. Dr.

CONTACT

+43 1 60191 72415; alexander.zoufaly@gesundheitsverbund.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 15, 2023
• Study Start: May 10, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)