Impact of Rapid Pathogen Detection in ICU Patients With Suspected Pneumonia on Antimicrobial Therapy

NCT06478953 | Completed Phase 2 DMC

• 1 other identifier: 2023.327
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this intervention trial is to determine the feasibility, safety, and potential impact of rapid respiratory pathogen detection by FA Pneumonia Panel on antibiotic therapy in mechanically ventilated critically ill patients with suspected pneumonia. Participants will randomized to either have an urgent BioFire FA Pneumonia Panel assay performed or recieve standard of care to guide antimicrobial therapy and treatment of pneumonia.

Conditions

Pneumonia; Critically Ill

Keywords

infection; antimicrobial; antibiotics; multidrug resistant organisms; antibiotic stewardship; intensive care

Outcome Measures

Primary Outcomes (1)

• Time interval to appropriate antimicrobial therapy

  Defined as the time interval (hours) from time of randomization to earliest time that appropriate antimicrobial therapy is achieved as determined by the antimicrobial stewardship review panel.

  7 days

Secondary Outcomes (9)

• Proportion of patients with appropriate antimicrobial therapy at 48 hours after randomization

  48 hours

• Time interval to pathogen detection

  7 days

• Duration of antimicrobial therapy between FA Pneumonia Panel guided and standard care group

  28 days

• Proportion of patients on broad-spectrum antibiotics at 48 hours after randomization

  48 hours

• Ventilator free days

  28 days

Study Arms (2)

FA Pneumonia Panel Guided Group

EXPERIMENTAL

Patients in the FA Pneumonia Panel guided group will have a BioFire® FilmArray® Pneumonia Panel assay performed as soon as possible but within 24 hours of new antibiotic prescription for suspected respiratory infection in addition to all the investigations performed in standard care. Based on the rapid test results, antimicrobial therapy will be adjusted according to a pre-determined treatment algorithm and antimicrobial guidelines. The treatment algorithm and antimicrobial guidelines were based on the latest hospital antibiogram, procalcitonin protocol, and consensus recommendations from microbiologists, infectious disease experts and intensive care physicians at our hospital. The treating clinical team will also be given the standard microbiological culture with sensitivity results when available. The treating clinical team may override the pre-determined antimicrobial algorithm for any clinical reason at any time and the rationale will be recorded.

Diagnostic Test: FA Pneumonia Panel

Standard Care Group

NO INTERVENTION

Patients in the standard care group will receive antimicrobial therapy guided by conventional microbiological cultures and standardized procalcitonin protocol. Choice of antimicrobial agent is based on use of the narrowest-spectrum antimicrobial agent possible according to culture sensitivity. Current standard investigations for any patient mechanically ventilated for suspected pneumonia in our ICU includes two sets of blood cultures, alternative day procalcitonin, respiratory specimen of tracheal aspirate or bronchoalveolar lavage for bacterial gram stain and cultures, respiratory viral PCR and urine streptococcus and legionella antigen. FA Pneumonia Panel will be performed from concurrent respiratory samples in the standard care group at the end of the study and the results will not be used by the treating clinical team for treatment decisions. Blinded results will only be available to the antimicrobial review panel for outcome assessment.

Interventions

FA Pneumonia Panel DIAGNOSTIC_TEST

A single BioFire® FilmArray® Pneumonia Panel assay will be performed on a respiratory clinical specimen.

FA Pneumonia Panel Guided Group

Eligibility Criteria

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

You may qualify if:

• adult (≥18 years old) ICU patients
• mechanical ventilation
• new antibiotic prescription within 24 hours for suspected community acquired, healthcare or ventilator associated pneumonia
• suspected pneumonia is defined as any of purulent sputum, cough, fever, shortness of breath, hypoxia, hypercapnia or abnormal white cell count AND chest infiltrates on imaging
• need for antibiotics other than suspected respiratory infection
• aspiration pneumonia
• suspected pneumonia due to tuberculosis
• known respiratory pathogens within 7 days prior to randomization
• given empirical antimicrobials for suspected Stenotrophomonas infection
• lack of sufficient respiratory samples for culture and FA Pneumonia Panel
• not expected to survive beyond 48 hours
• limitation of therapy prior to recruitment
• prisoners
• allergy to antibiotics
• immunosuppression from long term steroid of at least 5 mg/day or chemotherapy or HIV or haematological disease

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Pneumonia; Critical Illness; Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The antimicrobial stewardship review panel consisted of a microbiologist, an infectious diseases specialist and an intensive care physician that were blinded to study group allocation. At the study conclusion, the panel reviewed the clinical notes, imaging, laboratory data, conventional microbiological culture and FA Pneumonia Panel results to determine diagnosis, causative respiratory pathogen and appropriateness of antimicrobial therapy for each patient. A clinical diagnosis of pneumonia could be established even if a causative respiratory pathogen was not identified. Alternatively, non-infective diagnoses such as pulmonary oedema or secondary acute respiratory distress syndrome were attributed as the cause of respiratory failure if pneumonia was not present. Appropriate antimicrobial therapy was defined as use of the narrowest spectrum antimicrobial agent relative to the pathogen's sensitivity pattern. For patients who are considered not to have respiratory infection after retrosp
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Pilot, randomized, controlled open-label trial

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: June 27, 2024
• Study Start: June 26, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

HK (1)