Ventilator Associated Pneumonia Clinical Trial
— RAPIDOfficial title:
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics Versus Standard of Care Antibiotics and Diagnostics in Patients With Bloodstream Infection, Hospital-acquired Pneumonia or Ventilator-associated Pneumonia Due to Pseudomonas Aeruginosa or Carbapenemase Producing Enterobacterales (RAPID)
The goal of this clinical trial is to propose a seamless intervention linking rapid bacterial isolate identification and antibiotic resistance gene detection and targeted antibiotic prescription to minimise time between infection onset and appropriate treatment in patients with Pseudomonas aeruginosa or carbapenemase producing Enterobacterales infections. This is an investigator initiated trial. The primary hypothesis is that these interventions will lead to improved clinical outcomes amongst patients with hospital-acquired bloodstream infection, hospital-acquired pneumonia or ventilator-associated pneumonia due to carbapenem non-susceptible Pseudomonas aeruginosa or Enterobacterales, compared to standard antibiotic susceptibility testing. Patients will be randomised to either a control or intervention arm. Patients randomised to the intervention arm will have relevant specimens analysed by rapid microbiological diagnostics and will have early availability of ceftazidime-avibactam if appropriate. Patients randomised to the control arm, will have samples analysed by clinical microbiology laboratories using standard of care diagnostics. Antibiotics will be available to these patients as per usual institutional practice.
Status | Recruiting |
Enrollment | 1900 |
Est. completion date | December 31, 2026 |
Est. primary completion date | October 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. patient developed clinical symptoms compatible with bloodstream infection, hospital-acquired or ventilator-associated pneumonia (hospital-acquired and ventilator-associated pneumonia should fulfil US CDC NHSN criteria) AND, 2. an appropriate specimen has been received by the participating laboratory - that is, a blood culture bottle showing Gram negative bacilli or a respiratory sample collected for clinical purposes showing Gram negative bacilli on Gram stain; Exclusion Criteria: 1. Refractory shock or comorbid condition such that patient not expected to survive more than 48 hours; OR, 2. where the bloodstream infection is thought to be related to a vascular catheter and the catheter is unable to be removed; OR, 3. treatment is not with the intent to cure the infection; OR, 4. patient is incarcerated in a correctional facility; OR, 5. patients previously randomised in this trial within the last 60 days. |
Country | Name | City | State |
---|---|---|---|
Malaysia | University Malaya Medical Centre | Kuala Lumpur | |
Taiwan | Kaohsiung Medical University Hospital | Kaohsiung | |
Taiwan | Taichung Veterans General Hospital | Taichung | Xitun District |
Thailand | Sunpasitthiprasong Hospital | Ubon Ratchathani |
Lead Sponsor | Collaborator |
---|---|
National University of Singapore | Biomerieux inc, Pfizer |
Malaysia, Taiwan, Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Genomics studies | Genotype of the infection causing bacterial isolate, as available through whole genome sequencing | Day 0 | |
Primary | Composite endpoint of all-cause mortality and/or no improvement in SOFA score at Day 14 post index culture | Patient has died within 14 days from collection of index microbiology culture from any cause or SOFA score has not improved at Day 14 compared with baseline score on day of collection of index microbiology culture | 14 days post index culture | |
Secondary | Clinical response | Clinical response at Day 7 and Day 14 post index culture, as determined retrospectively by an adjudication committee | Day 7 and Day 14 post index culture | |
Secondary | All-cause mortality | All-cause mortality at Day 14, Day 28, and Day 60 post index culture | Day 14, Day 28, and Day 60 post index culture | |
Secondary | Functional outcome | Functional outcome at Day 14, Day 28 and Day 60 from collection of index culture | Day 14, Day 28 and Day 60 from collection of index culture | |
Secondary | Composite outcome | Composite outcome measure defined by Desirability of Outcome Ranking (DOOR) at Day 28 from index culture sample | Day 28 from index microbiology culture sample | |
Secondary | Implementation cost-Health Economics | Hospital and ICU level length of stay in the 60 days from randomisation | 60 days since enrolment |
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