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:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
NCT ID:
NCT06103500
Eligibility Criteria:
Inclusion Criteria:
1. Admitted
2. Age \>18 years old
3. Newly started (within 24 hours of assessment for eligibility) on at least one of the following antibiotic(s):
I. Vancomycin IV II. Linezolid III. Daptomycin IV. Clindamycin V. Cefazolin VI. Cloxacillin VII. Ceftriaxone VIII. Ceftazidime IX. Piperacillin-Tazobactam X. Meropenem (or Imipenem or Ertapenem) XI. Ciprofloxacin
4. Blood cultures ordered (within 12 hours before or after initiation of index antibiotics).
Overall Exclusion:
1. Pregnancy/breastfeeding
2. Documented end-of-life (palliative) care and are/will not be receiving ongoing antibiotic treatment.
3. Already enrolled in the trial.
4. Positive clinical culture results (those with speciation) for the index infection (within 72 hours) already available prior to assessment. Blood cultures with any Gram-positives will be an exclusion. Other cultures that are positive with a Gram-stain result but not speciation will not be an exclusion criteria.
5. Explanatory molecular test (e.g. legionella urinary antigen test, sars-cov-2 testing) within 72 hours prior to assessment.
6. Receipt of antimicrobials (not chronic suppression or prophylaxis) in the prior 24-72 hours (except if started in the outpatient setting or ED prior to admission in the 24-72 hours).
7. The index prescription is a continuation of an antibiotic given for suppressive chronic therapy or long-standing treatment of an established infection.
8. Index antibiotics are peri-operative only or ordered for \<24 hours.
9. Cystic fibrosis.
10. Known to be enrolled in a trial that dictates antimicrobial selection.
11. Not eligible for any of the algorithms.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06103500
Study Brief:
Protocol Section:
NCT06103500