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:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT06168734
Eligibility Criteria:
Inclusion Criteria:
* Male or female, ≥18 years of age.
* The patient or patient's legally authorized/acceptable representative (LAR) has voluntarily signed and dated the IRB/IEC approved ICF
* Meets the clinical diagnosis of ventilated HABP or VABP
* Have at least one of the following clinical criteria:
1. New onset or worsening of pulmonary symptoms and signs
2. New onset or worsening of purulent respiratory secretions
3. Hypoxemia
4. Need for acute changes in ventilator support
* Have at least one of the following clinical criteria:
1. Documented fever (defined as body temperature ≥ 38°C \[100.4°F\]
2. Hypothermia (defined as body temperature ≤ 35°C \[95°F\])
3. White blood cell (WBC) ≥10,000 cells/mm3 or ≤4,500 cells/mm3
4. \>15% immature neutrophils (bands).
* Have new or worsening infiltrate on a pulmonary imaging study that is consistent with bacterial pneumonia within 48 hours prior to randomization.
* Have a lower respiratory tract specimen sent for Gram stain and quantitative culture within 36 hours prior to the first dose of study drug.
Exclusion Criteria:
* Receipt of effective antibacterial treatment for pneumonia for a continuous duration of \>24 hours during the previous 72 hours prior to randomization.
* Pneumonia known or suspected to be caused by:
1. A bacterial pathogen resistant to meropenem, as assessed by susceptibility testing or against which either one or both study drugs lack activity
2. Viruses, atypical bacteria, or fungi
* Use of non-study systemic gram-negative therapy.
* Confounding respiratory conditions.
* Receiving extracorporeal membrane oxygenation (ECMO).
* Patients with refractory septic shock.
* Active immunosuppression.
* Has a history of serious hypersensitivity (e.g., anaphylaxis), serious allergy, or any serious reaction to cephalosporin, penicillin, carbapenem, or other β-lactam antibiotics.
* Female patients who are pregnant.
* Patients with eGFR \<10 mL/min/1.73 m2 or are receiving or starting renal replacement therapy or expected to require renal replacement therapy during the treatment phase of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06168734
Study Brief:
Protocol Section:
NCT06168734