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 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT03162250
Eligibility Criteria:
Inclusion Criteria:
* Body mass index greater than or equal (\>/=) 18 to less than or equal to (\</=) 40 kg/m\^2
* At randomization, participants must have \>/=1 blood culture or molecular diagnostic that is positive for Staphylococcal aureus (S. aureus) collected in the previous 120 hours
* In the investigator's judgment, an expected treatment duration for S. aureus intravenous infection with anti-staphylococcal SOC antibiotics \>/= 4 weeks
Exclusion Criteria:
* The presence of an intravascular catheter that is not planned to be removed within 96 hours of study randomization
* S. aureus bacteremia associated with an intracardiac device and/or intravascular prosthetic material (including hemodialysis access graft)
* In the investigator's judgement, S. aureus bacteremia involving infection of a prosthetic joint or vertebral hardware
* In participants with cirrhosis, a Child-Pugh Score of Class B or C
* Known rifampicin-resistant S. aureus
* Anticipated receipt of a rifamycin class (excluding rifaxamin) antibiotic from Day 1 to study completion/discontinuation
* In the investigator's judgment, the need for emergent valve surgery at the time of randomization or a high likelihood of cardiac surgery within 3 days after randomization
* Polymicrobial bacteremia
* Participants with significant immune suppression
* Participants with evidence of liver disease
* History or presence of an abnormal electrocardiogram (ECG)
* Exposure to any biological therapy or investigational biological agent within 90 days prior to the screening evaluation or have received any other investigational treatment 30 days prior to the screening evaluation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03162250
Study Brief:
Protocol Section:
NCT03162250