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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT02728518
Eligibility Criteria:
Inclusion Criteria:
* Patients admitted to ICU
* Clinical suspicion of VAP or HAP defined by a new persistent radiological infiltrate and one of the following signs:
* purulent tracheal aspirations, or
* temperature of 38° or higher, or leucocyte count \> 10000/ml or
* Positive culture sensitive to amikacin
* In case of empirical treatment, risk of multi resistant bacteria defined as follows:
* Antimicrobial therapy in preceding 90 days and
* Current hospitalization of 5 d or more
Exclusion Criteria:
* History of Asthma
* Multi organ failure or any psychiatric illness
* allergy to amikacin or intolerance to nebulized amikacin
* Myasthenia gravis.
* Severely impaired renal function (creatinine clearance lower than 10 mL/min or renal replacement therapy)
* Vestibulo-cochlear disease.
* Pregnancy.
* Brain death
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT02728518
Study Brief:
Protocol Section:
NCT02728518