Status:
RECRUITING
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Lead Sponsor:
National University of Singapore
Collaborating Sponsors:
Pfizer
Biomerieux inc
Conditions:
Blood Stream Infections
Ventilator Associated Pneumonia
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
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 mi...
Detailed Description
This is an open-label, multinational, randomised, superiority trial. Patients will be randomised to control and intervention arms. Patients randomised to the intervention arm, will have the BioFire B...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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.
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
1900 Patients enrolled
Trial Details
Trial ID
NCT05979545
Start Date
December 12 2023
End Date
December 31 2026
Last Update
March 6 2024
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 50603
2
Taichung Veterans General Hospital
Taichung, Xitun District, Taiwan, 1650
3
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
4
Sunpasitthiprasong Hospital
Ubon Ratchathani, Thailand, 34000