Skip to content

Quality control of antibiotic stewardship

Quality control of antibiotic stewardship

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN48029287
Enrollment
740
Registered
2022-06-16
Start date
2022-02-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower respiratory tract infection (LRTI) Respiratory

Interventions

The BIOFIRE® FILMARRAY® Pneumonia plus Panel tests for 18 bacteria (11 Gram-negative, 4 Gram-positive and 3 atypical), 7 antibiotic resistance markers, and 9 viruses that cause pneumonia and other low

Sponsors

University Hospital of Basel
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Clinical indication for diagnostic bronchoscopy with bronchoalveolar lavage 3. Suspicion of lower respiratory tract infection – in immunocompetent patients infiltrate must be confirmed; in immunocompromised patients an infiltrate is not required 4. Evidence of systemic inflammation (such as abnormal white blood cell count – either leukocytosis (>10.0x10e9/l) or leukopenia (<4.0x10e9/l) – or C-reactive protein (CRP) or procalcitonin (PCT) values above the local upper limit

Exclusion criteria

Exclusion criteria: 1. Ambulatory patients 2. Patients intubated at the time of inclusion 3. Neutropenic patients as defined by neutrophils <0.5x10e9/l 4. Haemodynamic instability or signs of life-threatening infection precluding a narrowing of antimicrobial therapy 5. Prior enrolment in an intervention study within the last 30 days 6. Women who are pregnant or breastfeeding

Design outcomes

Primary

MeasureTime frame
Time on inappropriate therapy in hours, recorded daily up to a total of 30 days, defined as anti-microbial therapy: 1. With no identifiable pathogen or 2. Not active according to in-vitro susceptibility testing of the identified pathogen or 3. With known intrinsic resistance of the identified pathogen to the given therapy or 4. Having a spectrum too broad for the identified pathogen (antimicrobial therapy considered broad when switching to a different antimicrobial therapy with a narrower spectrum continues to show a favourable clinical course) and in the case where there is a lack of evidence suggesting resistance of the microorganism to a narrower antimicrobial therapy or 5. Continuation of the antimicrobial therapy beyond the guideline-suggested duration e.g. for pneumonia 5 to 7 days

Secondary

MeasureTime frame
Clinical outcomes measured using patients’ medical records daily up to a total of 30 days: 1. Time to clinical stability (in hours) 2. Length of hospital stay (in hours) 3. Mortality 4. Adverse events

Countries

Germany, Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026