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 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT04531332
Eligibility Criteria:
Inclusion Criteria:
* Patients admitted to ICUs diagnosed as HAP or VAP
* Chest X-ray/ computed tomography showing new or progressive infiltrate.
* New onset of purulent sputum or change in sputum character.
* Body temperature greater than 38 ℃ or less than 35.5℃.
* White blood cell counts greater than 10000 /mm3 or less than 4000 /mm3.
* Significant quantitative pathogen cultures from respiratory secretions.
Exclusion Criteria:
* Age \<18 years, Pregnancy, Lactation
* Previous known allergic reaction to linezolid
* Creatinine Clearance (CrCl) \<10 mL/min, calculated according to the Cockcroft-Gault formula
* Thrombocytopenia (platelet count less than 80,000/mm3)
* Severe hepatic failure (Child-Pugh C)
* Concomitant treatment with other drugs that can potentially interfere with Linezolid (i.e., macrolides, serotonin modulators, omeprazole)
* Acute DIC score \> 4 points or hematological disorder
* Concurrent drug-associated Thrombocytopenia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04531332
Study Brief:
Protocol Section:
NCT04531332