Clinical Trials

Inclusion Criteria: 

• Adult (≥ 18 years) at the time of screening.
• Currently hospitalized.
• Identification of at least one gram-negative organism in a blood culture.
• Capable of providing written informed consent (includes through a legally authorized representative).
• Willingness to adhere to assigned study arm.
• Capable and willing to complete the follow-up QoL interview (including through a legally authorized representative).

Exclusion Criteria:

• Unable to tolerate or absorb a course of oral antibiotics after confirmation with the clinical team:
  • Patient who become able to tolerate oral medications during the enrollment window (i.e., up to 5 calendar days after the first positive blood culture is collected) are eligible for inclusion.
• Actively receiving vasopressors:
  • Patients receiving stable, low-level vasopressors can be considered for enrollment, with agreement of the Attending Physician.
• Gram-negative organism non-susceptible to at least one of the listed antibiotic agents in each study arm.
• Polymicrobial bloodstream infection:
  • The following patients with polymicrobial infections remain eligible for enrollment: (1) more than one morphology or species of a gram-negative organism (except for Acinetobacter baumannii or Stenotrophomonas maltophilia), (2) a single positive blood culture with a common commensal organism according to the Centers for Disease Control and Prevention National Healthcare Safety Network (grown in addition to an Enterobacterales species or P. aeruginosa (www.cdc.gov/nhsn/pdfs/validation/2019/2019-NHSN-Organisms-ListValidation.xlsx).
• Allergy or contraindication rendering no oral option or no IV option for therapy with the listed antibiotic agents.
• Anticipated duration of therapy greater than 14 days:
  • Patients who otherwise meet eligibility criteria and are enrolled will be included in the intention to treat analysis regardless of the duration of therapy of antibiotics prescribed. A subgroup analysis will specifically evaluate patients who received ≤8 days of active antibiotics.
• Central nervous system infection
• ANC of <500 cells/mL or anticipated to reduce to <500 cells/mL during the antibiotic treatment course:
  • Patients with ANC <500 cells/mL can be rescreened if the ANC increases to 500 cells/mL or greater during the enrollment window.
• Not a candidate for home IV therapy:
  • Discuss all patients with the Attending Physician prior to approaching the patient for informed consent to ensure that the patient is a candidate for home IV therapy and that there are not logistical issues that might preclude this option. Patients who are not candidates for home IV therapy but who are, at the time of screening, (1) expected to be hospitalized for the duration of the treatment course or (2) expected to be discharged to a skilled nursing facility are eligible for enrollment.
• Receiving hospice care:
  • Patients receiving palliative care only remain eligible for enrollment.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/4/23. Questions regarding updates should be directed to the study team contact.