A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection

Launched by INNOVIVA SPECIALTY THERAPEUTICS · Dec 18, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called sulbactam-durlobactam, which is being tested for its safety in treating infections caused by a type of bacteria known as Acinetobacter baumannii-calcoaceticus complex. The main focus is to see if this medication causes any allergic reactions, including more serious ones, in adults who have these infections. Participants in the study will be monitored for about 28 days to gather information about their health and any reactions they might experience.

To participate in this study, individuals must be at least 18 years old, currently hospitalized, and have a confirmed or suspected infection from the specific bacteria. They also need to be starting treatment with sulbactam-durlobactam as part of their regular care. It's important to note that people with a history of severe allergic reactions to certain antibiotics may not be eligible to take part. If someone joins the study, they will receive the standard treatment and be closely watched for any side effects, helping researchers understand how safe the medication is for patients.

Gender

ALL

Eligibility criteria

• 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 isolates, based on investigator's clinical judgment.
• • Participant initiates treatment with SUL-DUR per routine clinical care. Participants who receive SUL-DUR within 24 hours prior to enrollment are also eligible to participate. The decision to treat the participant with SUL-DUR is made prior to and independently of study participation.
• • The participant has an expected survival of \>48 hours at the time of written informed consent.
• Exclusion Criteria:
• • A history of significant hypersensitivity or allergic reaction to any β-lactam, or any contraindication to the use of β-lactam antibiotics