EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics

Recruiting now · Phase 4

Conditions studied: Blood Stream Infections, Ventilator Associated Pneumonia, Healthcare Associated Infection, Carbapenem-Resistant Enterobacteriaceae Infection, Hospital-acquired Pneumonia

In brief

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.

Key facts

Study ID

NCT05979545

Run by

National University of Singapore

People needed

1900

Starts

2023-12-12

Expected to finish

2026-12-31

Last updated by the study team

2024-03-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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,
• 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;

You may not qualify if…

• Refractory shock or comorbid condition such that patient not expected to survive more than 48 hours; OR,
• where the bloodstream infection is thought to be related to a vascular catheter and the catheter is unable to be removed; OR,
• treatment is not with the intent to cure the infection; OR,
• patient is incarcerated in a correctional facility; OR,
• patients previously randomised in this trial within the last 60 days.

Where it is running

• Taichung Veterans General Hospital — Taichung, Xitun District, Taiwan (enrolling)
• University Malaya Medical Centre — Kuala Lumpur, Malaysia
• Kaohsiung Medical University Hospital — Kaohsiung City, Taiwan
• Sunpasitthiprasong Hospital — Ubon Ratchathani, Thailand

Full record on ClinicalTrials.gov

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