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NCT05979545: RAPID

EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics

Recruiting now Phase 4 Last updated 6 March 2024
What this trial tests

Phase 4 trial testing Rapid Diagnostics in Blood Stream Infections in 1,900 participants. Currently enrolling.

Timeline
12 December 2023
Primary endpoint
31 October 2026
31 December 2026

Quick facts

Lead sponsorNational University of Singapore
PhasePhase 4
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment1,900
Start date12 December 2023
Primary completion31 October 2026
Estimated completion31 December 2026
Sites4 locations across Taiwan, Malaysia, Thailand

Drugs / interventions tested

Conditions studied

Sponsor

National University of Singapore

Who can join

Eligibility, any sex, with Blood Stream Infections or Ventilator Associated Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The impact of ceftazidime-avibactam on 30-day mortality in the treatment of OXA-48 producing <i>Enterobacterales</i> infections: a systematic review and meta-analysis.
    Foo AL, Young B, Ng OT, Vasoo S. · · 2026 · PMID 41510205 · DOI 10.1093/jacamr/dlaf238

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Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05979545.

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