A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection
Purpose
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.
Condition
- Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Acinetobacter baumannii-calcoaceticus complex (ABC) | Hospitalized participants with a proven or strongly suspected ABC infection who have received sulbactam-durlobactam as standard of care. |
|
Recruiting Locations
University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd
Kansas City 4273837, Kansas 4273857 66160
Kansas City 4273837, Kansas 4273857 66160
More Details
- Status
- Recruiting
- Sponsor
- Innoviva Specialty Therapeutics