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

A Single-arm, Open-label, Prospective, Observational Study to Assess the Safety of Sulbactam-durlobactam, Including the Risk of Hypersensitivity Reactions (Including Anaphylaxis) in Participants With Acinetobacter Baumannii-calcoaceticus Complex Infection

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.

Study Overview

• Status: Recruiting
• Conditions: Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
• Intervention / Treatment: Other: Non-interventional

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Reddy Tummala ISTX Clinical Trials; Phone Number: 617-715-3600; Email: Clinicaltrials@istx.com

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610-3003
      • Not yet recruiting
      • University of Florida - Gainesville
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd
  • Kentucky
    • Lexington, Kentucky, United States, 40536-7001
      • Not yet recruiting
      • University of Kentucky College of Medicine
  • Louisiana
    • New Orleans, Louisiana, United States, 70121-2429
      • Recruiting
      • Ochsner Medical Center - New Orleans
    • Shreveport, Louisiana, United States, 71103-4228
      • Recruiting
      • Ochsner LSU Health Science Center Shreveport
  • New York
    • The Bronx, New York, United States, 10467-2410
      • Not yet recruiting
      • Montefiore Medical Group Family Care Center
  • Ohio
    • Akron, Ohio, United States, 44304-1430
      • Recruiting
      • Summa Health System - Akron - 75 Arch Street
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • The Carl and Edyth Lindner Center for Research and Education at Christ Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213-2500
      • Not yet recruiting
      • University of Pittsburg School of Medicine
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Not yet recruiting
      • Prisma Health - Infectious Diseases - Greenville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Hospitalized participants

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acinetobacter baumannii-calcoaceticus complex (ABC); Hospitalized participants with a proven or strongly suspected ABC infection who have received sulbactam-durlobactam as standard of care.	Other: Non-interventional; Non-interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	28 days
Number of participants experiencing TEAEs	28 days
Incidence of maximum severity level of TEAEs	28 days
Incidence of related TEAEs as assessed by the investigator.	28 days
Incidence of serious TEAEs	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.	28 days
Number of participants experiencing AESIs	28 days
Incidence of maximum severity level of AESIs	28 days
Incidence of related AESIs as assessed by the investigator	28 days
Incidence of serious AESIs	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Actual observed values over time of liver function tests	Baseline and Day 28
Change from baseline values of liver function tests	Day 28
Actual observed values over time of systolic blood pressure	Baseline and Day 28
Change from baseline values over time of systolic blood pressure	Day 28
Actual observed values over time of diastolic blood pressure	Baseline and Day 28
Change from baseline values of diastolic blood pressure	Day 28
Actual observed values over time of temperature	Baseline and Day 28
Change from baseline values of temperature	Day 28
Actual observed values over time of pulse rate	Baseline and Day 28
Change from baseline values of pulse rate	Day 28
Actual observed values over time of respiration rate	Baseline and Day 28
Change from baseline values of respiration rate	Day 28
Summary of observed values over time of ECG QT measurements	Baseline and Day 28
Change from baseline values over time of ECG QT measurements	Day 28
Summary of observed values over time of hemoglobin	Baseline and Day 28
Change from baseline values over time of hemoglobin	Day 28
Summary of observed values over time of white blood count	Baseline and Day 28
Change from baseline values over time of white blood count	Day 28
Summary of observed values over time of platelets	Baseline and Day 28
Change from baseline values over time of platelets	Day 28

Collaborators and Investigators

• Sponsor: Innoviva Specialty Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Acinetobacter; ABC infection; Acinetobacter baumannii-calcoaceticus complex infection; Hospital-acquired bacterial pneumonia; Ventilator-associated bacterial pneumonia; Sulbactam-durlobactam
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Immune System Diseases; Hypersensitivity; Infections; Communicable Diseases; Anti-Bacterial Agents; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; beta-Lactamase Inhibitors; Sulbactam; Durlobactam
• Other Study ID Numbers: CS2514-2023-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected de-identified IPD may be shared
• IPD Sharing Time Frame: Data requests may be submitted starting 6 months after primary article publication and the data will be made accessible for up to 24 months; extensions may be considered on a case-by-case basis.
• IPD Sharing Access Criteria: Subject to certain criteria, conditions, and exceptions and upon completion of the review and approval of the Research Proposal and Statistical Analysis Plan, Qualified Researchers engaging in independent scientific research can be provided de-identified IPD following the execution of a Data Sharing Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No