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

Recruiting now

Conditions studied: Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)

In brief

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.

Key facts

Study ID

NCT06746883

Run by

Innoviva Specialty Therapeutics

People needed

100

Starts

2025-04-28

Expected to finish

2029-01-31

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• A history of significant hypersensitivity or allergic reaction to any β-lactam, or any contraindication to the use of β-lactam antibiotics

Where it is running

• UC Davis Health — Sacramento, California, United States (enrolling)
• University of Florida - Gainesville — Gainesville, Florida, United States (enrolling)
• Tampa General Hospital — Tampa, Florida, United States (enrolling)
• University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd — Kansas City, Kansas, United States (enrolling)
• University of Kentucky College of Medicine — Lexington, Kentucky, United States (enrolling)
• Ochsner Medical Center - New Orleans — New Orleans, Louisiana, United States (enrolling)
• Ochsner LSU Health Science Center Shreveport — Shreveport, Louisiana, United States (enrolling)
• Montefiore Medical Group Family Care Center — The Bronx, New York, United States (enrolling)
• Summa Health System - Akron - 75 Arch Street — Akron, Ohio, United States (enrolling)
• The Carl and Edyth Lindner Center for Research and Education at Christ Hospital — Cincinnati, Ohio, United States (enrolling)
• University of Pittsburg School of Medicine — Pittsburgh, Pennsylvania, United States (enrolling)
• Prisma Health - Infectious Diseases - Greenville — Greenville, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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