A Single-arm, Open-label, Prospective, Observational Study to Assess the Safety of Sulbactam-durlobactam, Including the Risk of Hypersensitivity Reactions (Including Anaphylaxis) in Participants With Acinetobacter Baumannii-calcoaceticus Complex Infection
Innoviva Specialty Therapeutics
Summary
The goal of this observational study is to evaluate the safety of sulbactam-durlobactam, as well as the risk of hypersensitivity reactions (including anaphylaxis) in participants with Acinetobacter baumannii-calcoaceticus complex infection. Participants will be followed for approximately 28 days in order to collect safety and reaction data.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant is ≥18 years old at the time of written informed consent and is hospitalized. * Participant has provided the written informed consent. If a participant is unable to provide written informed consent due to their medical condition, the participant's legally authorized representative may consent on behalf of the participant, or the decision can be made according to the procedure permitted by local law and institutional standard operating procedures (SOPs). * Participant has a proven or strongly suspected diagnosis of an infection caused by susceptible ABC isolat…
Interventions
- OtherNon-interventional
Non-interventional
Locations (8)
- University of Kansas Medical Center-Kansas City-3901 Rainbow BlvdKansas City, Kansas
- University of Kentucky College of MedicineLexington, Kentucky
- Ochsner Medical Center - New OrleansNew Orleans, Louisiana
- Ochsner LSU Health Science Center ShreveportShreveport, Louisiana
- Montefiore Medical Group Family Care CenterThe Bronx, New York
- Summa Health System - Akron - 75 Arch StreetAkron, Ohio