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 (“RAPID”)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0009822

Enrollment

Registered

2024-10-04

Start date

2024-12-02

Completion date

Unknown

Last updated

2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Medical Device : After 1:1 randomization, intervention arm: Patients with bacteremia, nosocomial pneumonia, or ventilator-associated pneumonia caused by Pseudomonas aeruginosa or carbapenemase-p

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) At risk of bloodstream infections, hospital-acquired pneumonia or ventilator-associated pneumonia due to Pseudomonas aeruginosa or carbapenemase producing Enterobacterales; OR, b) whose blood culture bottles show Gram negative bacilli; OR, c) who are suspected to have hospital-acquired pneumonia or ventilator-associated pneumonia and whose respiratory samples show Gram negative bacteria on Gram stain

Exclusion criteria

Exclusion criteria: a) Refractory shock or comorbid condition such that patient not expected to survive more than 48 hours; OR, b) where the bloodstream infection is thought to be related to a vascular catheter and the catheter is unable to be removed; OR, c) treatment is not with the intent to cure the infection; OR, d) patient is incarcerated in a correctional facility; OR, e) patients previously randomised in this trial within the last 60 days.

Design outcomes

Primary

Measure	Time frame
Composite endpoint of all-cause mortality and/or no improvement in SOFA score at Day 14 post index culture	—

Secondary

Measure	Time frame
Clinical response at Day 7 and Day 14 post index culture, as defined by a set of clinical criteria signifying cardiopulmonary stability for 48 hours;All-cause mortality at Day 14, Day 28, and Day 60 post index culture;Days alive and out of hospital in the 60 days from date of index culture;Length of stay in ICU & in hospital in the 60 days from date of index culture;Duration of mechanical ventilation in the 60 days from date of index culture;Persistence of bacteremia at Day 4 from date of index blood culture;Persistence of microbiologic growth at Day 7 from date of index respiratory culture, of at least one organism growing from index respiratory culture;Development of resistance to meropenem or ceftazidime-avibactam in any bacteria grown from clinically-indicated cultures collected in the 28 days from date of index culture;Development of acute kidney injury (modified KDIGO definitions) in the 28 days from date of index culture;Development of Clostridioides difficile diarrhea in the 28 days from date of index culture collection;Time from index culture sample received by the laboratory to antibiotic therapy active in vitro (in hours);Percentage of patients undergoing modification of antibiotic therapy in the 7 days after microbiology diagnostics for the index culture;Number of days on antibiotics in the 28 days from date of index culture collection (total, and by antibiotic type);Time from index culture sample received by the laboratory to detection of carbapenem resistance (in hours);Time from index culture sample received by the laboratory to detection of resistance to ceftriaxone/cefotaxime (in hours);Functional outcome at Day 14, Day 28 and Day 60 from collection of index culture;Composite outcome measure defined by Desirability of Outcome Ranking (DOOR) at Day 28 from index culture sample	—

Measure

Time frame

Clinical response at Day 7 and Day 14 post index culture, as defined by a set of clinical criteria signifying cardiopulmonary stability for 48 hours;All-cause mortality at Day 14, Day 28, and Day 60 post index culture;Days alive and out of hospital in the 60 days from date of index culture;Length of stay in ICU & in hospital in the 60 days from date of index culture;Duration of mechanical ventilation in the 60 days from date of index culture;Persistence of bacteremia at Day 4 from date of index blood culture;Persistence of microbiologic growth at Day 7 from date of index respiratory culture, of at least one organism growing from index respiratory culture;Development of resistance to meropenem or ceftazidime-avibactam in any bacteria grown from clinically-indicated cultures collected in the 28 days from date of index culture;Development of acute kidney injury (modified KDIGO definitions) in the 28 days from date of index culture;Development of Clostridioides difficile diarrhea in the 28 days from date of index culture collection;Time from index culture sample received by the laboratory to antibiotic therapy active in vitro (in hours);Percentage of patients undergoing modification of antibiotic therapy in the 7 days after microbiology diagnostics for the index culture;Number of days on antibiotics in the 28 days from date of index culture collection (total, and by antibiotic type);Time from index culture sample received by the laboratory to detection of carbapenem resistance (in hours);Time from index culture sample received by the laboratory to detection of resistance to ceftriaxone/cefotaxime (in hours);Functional outcome at Day 14, Day 28 and Day 60 from collection of index culture;Composite outcome measure defined by Desirability of Outcome Ranking (DOOR) at Day 28 from index culture sample

—

Countries

Korea, Republic of

Contacts

Public ContactJi Young Kwak

Seoul National University Bundang Hospital

ilsuplee96@naver.com+82-31-787-8218

Outcome results