A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection

Inclusion Criteria

• •1. Patient from birth (defined as post-natal age of 7 days) to \<18 years of age at the time of written informed consent (and assent, if applicable) and is hospitalized.
• •2. Patient and/or parent(s) or legal guardian(s) have provided the written informed consent and/or assent.
• •3. Patient has confirmed or suspected diagnosis of ABC infection and requires IV antibiotics for treatment.
• •4. Patient has expected survival of 30 days after enrollment in the study.
• •5. If patient is an individual of childbearing potential or reproductive potential, then the patient must remain abstinent OR must utilize one of the highly effective methods of contraception (ie, condom, combined oral contraceptive, implant, or injectable) from at least 30 days prior to screening until at least 30 days after administration of the last dose of study drug.
• •13. Patient has clinically significant abnormal laboratory test results not related to the underlying infection that might expose the patient to risk by participating in the trial, confound the results of the trial, or interfere with the patient's participation for the full duration of the trial.
• •14. Patient (or patient's mother, if the patient is being breastfed) has participated in a clinical study involving investigational medication or an investigational device within the last 30 days or 5 half-lives, whichever is longer, prior to first dose of the study drug.
• •15. Patient has any condition that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data.
• •16. Patient is unable or unwilling, in the opinion of the investigator, to comply with the protocol.
• •17. Patient (or patient's mother, if the patient is being breastfed) has previously received durlobactam.
• •18. Patient (or patient's mother, if the patient is being breastfed) has received sulbactam and/or sulbactam-containing regimens (eg, Unasyn) within 72 hours of first dose of the study drug.
• •19. Patient (or patient's mother, if the patient is being breastfed) has received amphotericin B within 7 days of first dose of the study drug.