Innoviva Specialty Therapeutics
The goal of this clinical trial is to investigate the use of Sulbactam-Durlobactam (SUL-DUR) in pediatric patients and is being conducted to collect pharmacokinetic (PK) and safety data to enable the identification of appropriate pediatric dosing regimens for patients with Acinetobacter baumannii-calcoaceticus complex (ABC) infections
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 abstin…
25mg/kg SUL and 25mg/kg DUR
20mg/kg SUL and 20mg/kg DUR
25mg/kg SUL and 25mg/kg DUR
20mg/kg SUL and 20mg/kg DUR