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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT03138733
Eligibility Criteria:
Inclusion Criteria:
* Male or female ≥ 18 years of age
* Staphylococcus aureus bacteremia (SAB), based on at least one positive blood culture obtained within the 72 h prior to randomization
* At least one of the following signs or symptoms of bacteremia:
1. fever (e.g.≥ 38 °C/100.4 °F measured orally)
2. white blood cell count \> 10,000 or \< 4,000 cells/µL, or \> 10% immature neutrophils (bands)
3. tachycardia (heart rate \> 90 bpm)
4. hypotension (systolic blood pressure \< 90 mmHg)
* At least one of the following:
1. SAB in patients undergoing chronic intermittent hemodialysis or peritoneal dialysis
2. Persistent SAB
3. Definite native-valve right-sided infective endocarditis by Modified Duke's Criteria
4. Other forms of complicated SAB
5. Osteomyelitis (including vertebral, sternal, or long-bone osteomyelitis)
6. Epidural or cerebral abscess
* Other inclusion criteria have been applied
Exclusion Criteria:
* Treatment with potentially effective (anti-staphylococcal) systemic antibacterial treatment for more than 48 h within the 7 days prior to randomization; Exception: Documented failure of bloodstream clearance
* Bloodstream or non-bloodstream concomitant infections with Gram-negative bacteria that are known to be non-susceptible to either ceftobiprole or aztreonam
* Left-sided infective endocarditis
* Prosthetic cardiac valves or valve support rings, cardiac pacemakers, automatic implantable cardioverter-defibrillator, or left-ventricular assist devices
* Community- or hospital-acquired pneumonia
* Opportunistic infections within 30 days prior to randomization, where the underlying cause of these infections is still active
* Requirement for continuous renal-replacement therapy
* Women who are pregnant or nursing
* Other exclusion criteria have been applied
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03138733
Study Brief:
Protocol Section:
NCT03138733