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 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT02070757
Eligibility Criteria:
Key Inclusion Criteria:
* Adult participants diagnosed with either VABP or ventilated HABP requiring IV antibiotic therapy;
* Intubated and on mechanical ventilation at the time of randomization;
* New or progressive infiltrate on chest radiography consistent with pneumonia;
* Presence of clinical criteria consistent with a diagnosis of ventilated nosocomial pneumonia.
Key Exclusion Criteria:
* History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics;
* Prior non-study antibiotics for \> 24 hours;
* Gram stain of lower respiratory tract specimen showing only gram positive bacteria;
* Active immunosuppression;
* End-stage renal disease or requirement for dialysis;
* Expected survival \< 72 hours;
* Severe confounding respiratory condition (i.e., chest trauma with paradoxical respiration);
* Known or suspected community-acquired bacterial pneumonia.
* Anticipated concomitant use of any of the following medications during the course of study therapy: valproic acid or divalproex sodium. Anticipated concomitant use of serotonin re-uptake inhibitors, tricyclic antidepressants, or serotonin 5-HT1 receptor agonists (triptans), meperidine, or buspirone during the course of linezolid treatment.
* Receipt of a monoamine oxidase inhibitor within 14 days prior to the first dose of study drug or anticipated concomitant use during the course of linezolid therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02070757
Study Brief:
Protocol Section:
NCT02070757