EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics (RAPID)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

National University Of Singapore

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Decision date (initial)

2026-04-29

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Pfizer Inc., bioMérieux

External identifiers

EU CT number

2024-520067-13-00

ClinicalTrials.gov

NCT05979545

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Diagnosis, Therapy

To quantify the combined effect of rapid microbiology diagnostic system and locally adapted antibiotic stewardship on patients with infections due to Pseudomonas aeruginosa or carbapenemase producing Enterobacterales, which include bloodstream infections, hospital-acquired pneumonia and ventilator-associated pneumonia.

Secondary objectives 1

1. A multi-faceted assessment of the trial intervention in terms of patient clinical outcomes, safety and adverse events associated with antibiotic treatments, microbiology testing process measures, and health economic costs

Conditions and MedDRA coding

Bloodstream Infection, Ventilator Associated Pneumonia and Hospital-Acquired Pneumonia

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Adults (above 18 years old) who are at risk of bloodstream infections, hospital-acquired pneumonia or ventilator-associated pneumonia due to Pseudomonas aeruginosa or carbapenem-resistant Enterobacterales; OR
2. Adults (above 18 years old) whose blood culture bottles show Gram negative bacilli; OR
3. Adults (above 18 years old) who are suspected to have hospital-acquired pneumonia or ventilator-associated pneumonia and whose respiratory samples show Gram negative bacteria on Gram stain
4. Consenting criteria review and Informed consent signature

Exclusion criteria 9

1. Refractory shock or comorbid condition such that patient not expected to survive more than 48 hours; OR,
2. where the bloodstream infection is thought to be related to a vascular catheter and the catheter is unable to be removed; OR
3. treatment is not with the intent to cure the infection; OR,
4. patient has an infection that needs prolonged antibiotic treatment (i.e more than 2 weeks); OR,
5. patient is incarcerated in a correctional facility; OR,
6. patients previously enrolled in this trial within the last 60 days.
7. Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer. Patients for whom the proposed washout period is incompatible or inapplicable should not be enrolled in the clinical trial but should follow a standard clinical treatment plan; OR
8. Treating doctor deems enrolment into the trial is not in the best interest of the patient
9. Pregnant or breastfeeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Composite endpoint of all-cause mortality and/or no improvement in Sequential Organ Failure Assessment (SOFA) score at Day 14 post index culture

Secondary endpoints 21

1. 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
2. All-cause mortality at Day 14, Day 28, and Day 60 post index culture
3. Days alive and out of hospital in the 60 days from date of index culture
4. Length of stay in ICU in the 60 days from date of index culture
5. Length of stay in hospital in the 60 days from date of index culture
6. Type of accommodation on discharge from hospital
7. Duration of mechanical ventilation in the 60 days from date of index culture
8. Persistence of bacteremia at Day 4 from date of index blood culture
9. Persistence of microbiologic growth at Day 7 from date of index respiratory culture, of at least one organism growing from index respiratory culture
10. 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
11. Development of acute kidney injury (modified KDIGO definitions) in the 28 days from date of index culture<
12. Development of Clostridioides difficile diarrhea in the 28 days from date of index culture collection
13. Time from index culture sample received by the laboratory to antibiotic therapy active in vitro (in hours)<
14. Percentage of patients undergoing modification of antibiotic therapy in the 7 days after microbiology diagnostics for the index culture
15. Number of days on antibiotics in the 28 days from date of index culture collection (total, and by antibiotic type)<
16. Time from index culture sample received by the laboratory to detection of carbapenem resistance (in hours
17. Time from index culture sample received by the laboratory to detection of resistance to ceftriaxone/cefotaxime (in hours)<
18. Time from index culture sample received by the laboratory to detection of Acinetobacter baumannii calcoaceitcus complex or Stenotrophomonas maltophilia (in hours
19. Functional outcome at Day 28 and Day 60 from collection of index culture
20. Composite outcome measure defined by Desirability of Outcome Ranking (DOOR) at Day 28 from index culture sample
21. Cost-effectiveness of the Intervention, compared to Control, from the health system perspective, Up to 60 days from date of index culture

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

National University Of Singapore

Sponsor organisation

National University Of Singapore

Address

21 Lower Kent Ridge Road

City

Singapore

Postcode

119077

Country

Singapore

Scientific contact point

Organisation

National University Of Singapore

Contact name

ADVANCE-ID Network

Public contact point

Organisation

National University Of Singapore

Contact name

ADVANCE-ID Network

Third parties 6

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications