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

Last updated: June 23, 2026
Sponsor: Innoviva Specialty Therapeutics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergy

Allergies & Asthma

Treatment

Non-interventional

Sulbactam-Durlobactam

Clinical Study ID

NCT06746883
CS2514-2023-003
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Participant is ≥18 years old at the time of written informed consent and ishospitalized.

  • Participant has provided the written informed consent. If a participant is unable toprovide written informed consent due to their medical condition, the participant'slegally authorized representative may consent on behalf of the participant, or thedecision can be made according to the procedure permitted by local law andinstitutional standard operating procedures (SOPs).

  • Participant has a proven or strongly suspected diagnosis of an infection caused bysusceptible ABC isolates, based on investigator's clinical judgment.

  • Participant initiates treatment with SUL-DUR per routine clinical care. Participantswho receive SUL-DUR within 24 hours prior to enrollment are also eligible toparticipate. The decision to treat the participant with SUL-DUR is made prior to andindependently of study participation.

  • The participant has an expected survival of >48 hours at the time of writteninformed consent.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Non-interventional
Phase:
Study Start date:
April 28, 2025
Estimated Completion Date:
January 31, 2029

Connect with a study center

  • UC Davis Health

    Sacramento, California 95817
    United States

    Active - Recruiting

  • University of Florida - Gainesville

    Gainesville, Florida 32610-3003
    United States

    Active - Recruiting

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • University of Kentucky College of Medicine

    Lexington, Kentucky 40536-7001
    United States

    Active - Recruiting

  • Ochsner Medical Center - New Orleans

    New Orleans, Louisiana 70121-2429
    United States

    Active - Recruiting

  • Ochsner LSU Health Science Center Shreveport

    Shreveport, Louisiana 71103-4228
    United States

    Active - Recruiting

  • Montefiore Medical Group Family Care Center

    The Bronx, New York 10467-2410
    United States

    Active - Recruiting

  • Summa Health System - Akron - 75 Arch Street

    Akron, Ohio 44304-1430
    United States

    Active - Recruiting

  • The Carl and Edyth Lindner Center for Research and Education at Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • University of Pittsburg School of Medicine

    Pittsburgh, Pennsylvania 15213-2500
    United States

    Active - Recruiting

  • Prisma Health - Infectious Diseases - Greenville

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

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