ceftazidime, avibactam for Bloodstream infection | Hospital-acquired pneumonia | Ventilator-associated pneumonia

Inclusion criteria

• {"criterion_text":"- 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"}
• {"criterion_text":"- Adults (above 18 years old) whose blood culture bottles show Gram negative bacilli; OR"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Consenting criteria review and Informed consent signature"}

Exclusion criteria

• {"criterion_text":"- Refractory shock or comorbid condition such that patient not expected to survive more than 48 hours; OR,"}
• {"criterion_text":"- where the bloodstream infection is thought to be related to a vascular catheter and the catheter is unable to be removed; OR"}
• {"criterion_text":"- treatment is not with the intent to cure the infection; OR,"}
• {"criterion_text":"- patient has an infection that needs prolonged antibiotic treatment (i.e more than 2 weeks); OR,"}
• {"criterion_text":"- patient is incarcerated in a correctional facility; OR,"}
• {"criterion_text":"- patients previously enrolled in this trial within the last 60 days."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Treating doctor deems enrolment into the trial is not in the best interest of the patient"}
• {"criterion_text":"- Pregnant or breastfeeding"}

Primary endpoints

• {"endpoint_text":"- Composite endpoint of all-cause mortality and/or no improvement in Sequential Organ Failure Assessment (SOFA) score at Day 14 post index culture","definition_or_measurement_approach":"Assessed at Day 14 post index culture (composite of all-cause mortality and/or no improvement in SOFA score at Day 14 post index culture)"}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Clinical response assessed at Day 7 and Day 14 post index culture using criteria for cardiopulmonary stability for 48 hours"}
• {"endpoint_text":"- All-cause mortality at Day 14, Day 28, and Day 60 post index culture","definition_or_measurement_approach":"All-cause mortality assessed at Day 14, Day 28, and Day 60 post index culture"}
• {"endpoint_text":"- Days alive and out of hospital in the 60 days from date of index culture","definition_or_measurement_approach":"Calculated as days alive and discharged within 60 days from index culture"}
• {"endpoint_text":"- Length of stay in ICU in the 60 days from date of index culture","definition_or_measurement_approach":"ICU length of stay measured within 60 days from index culture"}
• {"endpoint_text":"- Length of stay in hospital in the 60 days from date of index culture","definition_or_measurement_approach":"Hospital length of stay measured within 60 days from index culture"}
• {"endpoint_text":"- Type of accommodation on discharge from hospital","definition_or_measurement_approach":"Recorded type of accommodation at hospital discharge"}
• {"endpoint_text":"- Duration of mechanical ventilation in the 60 days from date of index culture","definition_or_measurement_approach":"Duration of mechanical ventilation within 60 days from index culture"}
• {"endpoint_text":"- Persistence of bacteremia at Day 4 from date of index blood culture","definition_or_measurement_approach":"Persistence of bacteremia assessed at Day 4 from index blood culture"}
• {"endpoint_text":"- Persistence of microbiologic growth at Day 7 from date of index respiratory culture, of at least one organism growing from index respiratory culture","definition_or_measurement_approach":"Persistence of microbiologic growth assessed at Day 7 from index respiratory culture (at least one organism)"}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Detection of resistance to meropenem or ceftazidime-avibactam in cultures collected within 28 days from index culture"}
• {"endpoint_text":"- Development of acute kidney injury (modified KDIGO definitions) in the 28 days from date of index culture<","definition_or_measurement_approach":"AKI measured using modified KDIGO definitions within 28 days from index culture"}
• {"endpoint_text":"- Development of Clostridioides difficile diarrhea in the 28 days from date of index culture collection","definition_or_measurement_approach":"Occurrence of C. difficile diarrhea within 28 days from index culture"}
• {"endpoint_text":"- Time from index culture sample received by the laboratory to antibiotic therapy active in vitro (in hours)<","definition_or_measurement_approach":"Time in hours from laboratory receipt of index culture to initiation of antibiotic therapy that is active in vitro"}
• {"endpoint_text":"- Percentage of patients undergoing modification of antibiotic therapy in the 7 days after microbiology diagnostics for the index culture","definition_or_measurement_approach":"Proportion of patients with antibiotic regimen modification within 7 days after microbiology diagnostics for index culture"}
• {"endpoint_text":"- Number of days on antibiotics in the 28 days from date of index culture collection (total, and by antibiotic type)<","definition_or_measurement_approach":"Number of antibiotic days counted within 28 days from index culture (overall and by antibiotic type)"}
• {"endpoint_text":"- Time from index culture sample received by the laboratory to detection of carbapenem resistance (in hours","definition_or_measurement_approach":"Time in hours from receipt of index culture to detection of carbapenem resistance"}
• {"endpoint_text":"- Time from index culture sample received by the laboratory to detection of resistance to ceftriaxone/cefotaxime (in hours)<","definition_or_measurement_approach":"Time in hours from receipt of index culture to detection of resistance to ceftriaxone/cefotaxime"}
• {"endpoint_text":"- Time from index culture sample received by the laboratory to detection of Acinetobacter baumannii calcoaceitcus complex or Stenotrophomonas maltophilia (in hours","definition_or_measurement_approach":"Time in hours from receipt of index culture to detection of A. baumannii complex or S. maltophilia"}
• {"endpoint_text":"- Functional outcome at Day 28 and Day 60 from collection of index culture","definition_or_measurement_approach":"Functional outcome assessed at Day 28 and Day 60 from index culture"}
• {"endpoint_text":"- Composite outcome measure defined by Desirability of Outcome Ranking (DOOR) at Day 28 from index culture sample","definition_or_measurement_approach":"DOOR composite outcome assessed at Day 28 from index culture"}
• {"endpoint_text":"- Cost-effectiveness of the Intervention, compared to Control, from the health system perspective, Up to 60 days from date of index culture","definition_or_measurement_approach":"Health system perspective cost-effectiveness assessed up to 60 days from index culture"}

Italy

Earliest CTIS Part Ii Submission Date

20-01-2026

Latest Decision Or Authorization Date

29-04-2026

Processing Time Days

99

Number Of Sites

4

Number Of Participants

80

Primary sponsor

Full Name

National University Of Singapore

Organisation Type

Educational Institution

Country Of Registered Address

Singapore

Third parties

• {"country":"United States","full_name":"Pfizer Inc.","duties_or_roles":"Pharmaceutical Support; code 8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code 6; code 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Italy","full_name":"Euromed Pharma Services S.r.l.","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
• {"country":"Singapore","full_name":"National University Of Singapore","duties_or_roles":"code 4","organisation_type":"Educational Institution"}
• {"country":"United Kingdom","full_name":"BioMérieux","duties_or_roles":"Diagnostic support","organisation_type":"Industry"}
• {"country":"Italy","full_name":"Consorzio Per Valutazioni Biologiche E Farmacologiche","duties_or_roles":"code 1; code 11; code 12; code 14; code 5","organisation_type":"Pharmaceutical company"}