An interventional study of Respiratory Panel PCR Sputum in Respiratory Infection, sponsored by Alexander Zoufaly. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Alexander Zoufaly · Not applicable, Interventional, and Diagnostic
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?
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
o 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
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 302 is above the median of 120 across 4,201 interventional studies indexed under Infections.
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AND (one of the following diagnosis)
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:
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
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
Multiplex PCR Respiratory Panel from Biomerieux used on Patients Sputum
length of stay (LOS) in days
How long is the lenght of stay in days (half-days)?
Time frame: From admission to discharge or death, whichever comes first, assessed up to 12 Months
Duration of antibiotic treatment needed represented as days of treatment (DOT)
How long is the duration of antibiotic treatment in days?
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
Is there a difference in used antibiotic treatment?
Time frame: 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?
Time frame: 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?
Time frame: 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?
Time frame: From admission to death or 30 days after admission
30-day re-admission rate
Is there a difference in 30-day re-admission rate?
Time frame: From admission to death or 30 days after admission
Plan to share: No
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