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 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT01799993
Eligibility Criteria:
Inclusion Criteria:
* Males and non-pregnant, non-lactating females, 18 years of age or older
* Intubated and mechanically-ventilated
* Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on chest radiograph
* Presence of Gram-negative organism(s) by either Gram stain or culture of respiratory secretions, or suspected Gram-negative pathogen
* Impaired oxygenation
* Clinical Pulmonary Infection Score (CPIS) of at least 6
* Presence of a multi-drug resistant (MDR) organism in a pre-therapy respiratory specimen OR at least two risk factors for MDR organisms
Exclusion Criteria:
* History of hypersensitivity to amikacin or other aminoglycosides
* Has received antibiotic therapy for Gram-negative pneumonia for greater than 48 hours at the time of randomization
* Known or suspected bacteremia secondary to Staphylococcus aureus
* A positive urine and/or serum beta-human Chorionic Gonadotropin pregnancy test
* Patients with a serum creatinine \> 2 mg/dL (177 µmol/L) \[Exception: Patients with a serum creatinine \> 2 mg/dL (177 µmol/L) and being treated with continuous renal replacement therapy (Continuous Veno-Venous Hemodialysis and CVVHemoDiafiltration) or daily hemodialysis will receive the aerosol study drug treatment\]
* Has been on mechanical ventilation for \> 28 days
* Is participating in or has participated in other investigational interventional studies within the last 28 days prior to study treatment
* The risk of rapidly fatal illness and death within 72 hrs, or any concomitant condition not related to ventilator-associated pneumonia that, in the opinion of the investigator, precludes completion of study evaluations and the course of therapy
* Has an Acute Physiology and Chronic Health Evaluation (APACHE) II score \< 10
* Patients receiving veno-venous extracorporeal circulation membrane oxygenation (V-V ECMO)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01799993
Study Brief:
Protocol Section:
NCT01799993