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.
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Percentage of participants experiencing Treatment Emergent Adverse Events (TEAEs) defined as any event after exposure to sulbactam-durlobactam (SUL-DUR), or event already present that worsens in either intensity or frequency after exposure
Timeframe: 28 days
Number of participants experiencing TEAEs
Timeframe: 28 days
Incidence of maximum severity level of TEAEs
Timeframe: 28 days
Incidence of related TEAEs as assessed by the investigator.
Timeframe: 28 days
Incidence of serious TEAEs
Timeframe: 28 days
Percentage of participants experiencing Adverse Events of Special Interest (AESIs) defined as an AE or SAE of concern specific to the sponsor, for which ongoing monitoring is needed. AESIs include: Hypersensitivity reactions, including anaphylaxis.
Timeframe: 28 days
Number of participants experiencing AESIs
Timeframe: 28 days
Incidence of maximum severity level of AESIs
Timeframe: 28 days
Incidence of related AESIs as assessed by the investigator
Timeframe: 28 days
Incidence of serious AESIs
Timeframe: 28 days