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 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT03012360
Eligibility Criteria:
Inclusion Criteria:
* All adult patients hospitalized in the ICU with a first episode of VAT diagnosed \>48 hours after starting invasive mechanical ventilation are eligible for this study.
VAT is defined using the following criteria:
1. absence of new infiltrate on chest X ray
2. two of the three following conditions: fever \> 38.5 °C or \<36.5, leucocyte count \> than 12 000 cells per μL or \<than 4000 cells per μL purulent tracheal secretions
3. and positive tracheal aspirate (≥105 cfu/mL)
Exclusion Criteria:
* long-term tracheostomy at ICU admission
* patients who develop VAP before VAT
* patients already receiving antibiotics active against all the microorganisms responsible for VAT
* severe immunosuppression
* pregnancy or breastfeeding
* patients \<18 years
* patients already included in another study, with potential interaction with the primary objective of the current study
* known resistance to imipenem and ciprofloxacin of bacteria responsible for VAT
* treatment limitation decisions
* moribund patients (likely to die within 24 h)
* allergy to any of study drugs: hypersensitivity to any carbapenem, severe hypersensitivity (for example anaphylactic reaction or severe cutaneous reaction) to any other antibiotic form beta-lactam group (such as penicillin or cephalosporin), severe hypersensitivity (for example anaphylactic reaction) to any other antibiotic from beta-lactam group (penicillin, monobactam or carbapenem), hypersensitivity to quinolones
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03012360
Study Brief:
Protocol Section:
NCT03012360