Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT05258851
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged ≥ 18 years.
2. Admitted to an intensive care unit (ICU).
3. Patients with hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP), complicated urinary tract infection (cUTI), bacteremia, complicated intraabdominal infection (cIAI), and complicated skin and soft tissue infection (cSSTI).
4. Confirmed infection with CRE, based on a culture and sensitivity obtained within the past 72 hours of study enrollment.
5. Suspected CRE infection according to one of the following: (1) positive Xpert Carba-R test screening for blaKPC or blaOXA-48 or blaNDM or blaVIM or blaIMI assessed on the admission to the ICU, (2) positive culture for CRE obtained within 3 months from time of enrollment.
Exclusion Criteria:
1. Acute Physiology and Chronic Health Evaluation II (APACHE II) score more than 30
2. known significant hypersensitivity reaction to beta-lactam antibiotics or colistin
3. Positive culture for Stenotrophomonas maltophilia or Acinetobacter baumannii within the current hospitalization.
4. Patients received the study intervention or control for more than 24 hours before the intended randomization.
5. Patient/substitute decision-maker or caring physician's refusal to enroll in the study.
6. Patient with concomitant suspected or confirmed meningitis.
7. Pregnancy.
8. Cystic fibrosis.
9. Patients with Do Not Attempt to Resuscitate (DNAR) code status.
10. Prior knowledge that the index CRE pathogen was resistant to colistin (MIC \>2 μg/ml) or ceftazidime-avibactam (MIC \> 8 μg/ml) before randomization.
11. Objective clinical evidence for any of the following infections that necessitate study therapy for \>14 days: endovascular infection, including endocarditis, osteomyelitis, prosthetic joint infection, meningitis, and/or other central nervous system infections
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05258851
Study Brief:
Protocol Section:
NCT05258851