Actively Recruiting
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Led by National University of Singapore · Updated on 2024-03-06
1900
Participants Needed
4
Research Sites
159 weeks
Total Duration
On this page
Sponsors
N
National University of Singapore
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has clinical symptoms compatible with bloodstream infection, hospital-acquired pneumonia, or ventilator-associated pneumonia (meeting US CDC NHSN criteria for pneumonia)
- An appropriate specimen has been received by the participating laboratory showing Gram negative bacilli on Gram stain in blood culture or respiratory sample
You will not qualify if you...
- Patient has refractory shock or a medical condition expected to result in death within 48 hours
- Bloodstream infection is related to a vascular catheter that cannot be removed
- Treatment is not intended to cure the infection
- Patient is incarcerated in a correctional facility
- Patient was previously randomized in this trial within the last 60 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 50603
Not Yet Recruiting
2
Taichung Veterans General Hospital
Taichung, Xitun District, Taiwan, 1650
Actively Recruiting
3
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
Not Yet Recruiting
4
Sunpasitthiprasong Hospital
Ubon Ratchathani, Thailand, 34000
Not Yet Recruiting
Research Team
K
Kithalakshmi Vignesvaran
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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