Actively Recruiting
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
Led by National University of Singapore · Updated on 2024-03-06
1900
Participants Needed
4
Research Sites
8 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
Researchers are evaluating the use of rapid bacterial identification and antibiotic resistance gene detection combined with targeted antibiotic treatment in patients with infections caused by Pseudomonas aeruginosa or carbapenemase producing Enterobacterales. This trial aims to reduce the time between infection onset and appropriate treatment in hospital-acquired bloodstream infections, hospital-acquired pneumonia, or ventilator-associated pneumonia. The study is an open-label, multinational, randomized trial comparing these rapid diagnostics and targeted therapy with standard antibiotic susceptibility testing. The goal is to see if this approach improves clinical outcomes compared to usual care. Participants are randomly assigned to either an intervention or control group. The intervention group will have specimens tested with the BioFire Blood Culture Identification 2 Panel for blood infections and the BioFire FilmArray Pneumonia or Pneumonia plus Panel for respiratory infections. Antibiotic guidelines will support treatment decisions and ceftazidime-avibactam will be available for targeted use when appropriate. The control group will receive standard microbiology testing and antibiotics as per usual hospital practice. The main population includes hospitalized patients with the specified infections, and a secondary group includes those with multidrug-resistant Gram-negative bacteria. Participants will be monitored for clinical and mortality outcomes up to 60 days after infection onset. Bacterial isolates will be collected for genetic analysis through whole genome sequencing. The primary outcome is a combination of all-cause mortality and lack of improvement in organ function score at 14 days post infection. Additional outcomes include clinical response, mortality at different time points, functional status, composite outcomes at 28 days, and health economic assessments. The study plans to enroll 1900 participants across 20 sites, with ongoing safety and clinical assessments throughout the trial.
CONDITIONS
Brief 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
- An appropriate specimen has been received by the laboratory showing Gram-negative bacilli on Gram stain from blood culture or respiratory sample
You will not qualify if you...
- Patient in refractory shock or with a condition expected to cause death within 48 hours
- Bloodstream infection 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 has been 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of infection treatment as determined by clinical care
Participants receive either rapid diagnostic testing with targeted antibiotic treatment using ceftazidime-avibactam if appropriate, or standard of care diagnostics and antibiotics as per usual practice.
Visits as per clinical care during treatment period
Duration - 60 days post infection
Participants are monitored for clinical and mortality outcomes for 60 days post infection.
Follow-up assessments at Days 7, 14, 28, and 60
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here