EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNational University of Singapore

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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,

Trial design

Treatments tested in this trial

  • Rapid Diagnostics

Treatment groups

1,900 Participants
are divided into 2 treatment groups

Sponsors and collaborators

National University of Singapore

Lead sponsor

Pfizer

Collaborator

Biomerieux inc

Collaborator