Assessing the impact of rapid pathogen identification on hospital stay for respiratory infections
Effect of IN Hospital PCR Based Assessment of Patients With Lower Respiratory Tract Infections on LEngth of Stay - INHALE Trial
This study is testing if a quick test for germs causing lung infections can help hospitalized patients get better faster and spend less time in the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 302 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Klinik Favoriten Academic / other |
| Locations | 1 site (Wien, Österreich) |
| Trial ID | NCT05904223 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates whether using the BIOFIRE® FILMARRAY® Pneumonia Panel can reduce the length of hospital stay for patients with lower respiratory tract infections by quickly identifying the causative pathogens. The study aims to compare the outcomes of patients receiving this rapid assessment against those receiving standard care, focusing on antibiotic treatment duration and appropriateness. By providing results within 1.5 hours, the intervention seeks to minimize unnecessary broad-spectrum antibiotic use and associated side effects. The trial includes hospitalized patients aged 18 and older who can produce sputum and have specific respiratory conditions.
Who should consider this trial
Good fit: Ideal candidates include hospitalized adults with acute exacerbations of COPD, pneumonia, or other lower respiratory infections who can provide sputum samples.
Not a fit: Patients with other proven or suspected systemic diseases requiring antibiotic treatment, such as intra-abdominal infections, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to shorter hospital stays and more targeted antibiotic treatments for patients with respiratory infections.
How similar studies have performed: Other studies have shown promising results with rapid pathogen identification methods, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) 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 Exclusion Criteria: * 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) * 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
Where this trial is running
Wien, Österreich
- Klinik Favoriten — Wien, Österreich, Austria (Recruiting)
Study contacts
- Principal investigator: Alexander Zoufaly, Prof. Dr. — Klinik Favoriten
- Study coordinator: Klaus Breinbauer, Dr. med.
- Email: klaus.breinbauer@gesundheitsverbund.at
- Phone: +43 1 60191 72454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.