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

NCT06746883 | Recruiting

• 1 other identifier: CS2514-2023-003
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)

Keywords

ABC infection; Acinetobacter baumannii-calcoaceticus complex infection; Hospital-acquired bacterial pneumonia; Ventilator-associated bacterial pneumonia; Sulbactam-durlobactam; Acinetobacter

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (20)

• 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

Study Arms (1)

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

Interventions

Non-interventional OTHER

Non-interventional

Acinetobacter baumannii-calcoaceticus complex (ABC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospitalized participants

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

Sponsors & Collaborators

• Innoviva Specialty Therapeutics: lead

Study Sites (8)

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

Kansas City, Kansas, 66160, United States

RECRUITING

University of Kentucky College of Medicine

Lexington, Kentucky, 40536-7001, United States

NOT YET RECRUITING

Ochsner Medical Center - New Orleans

New Orleans, Louisiana, 70121-2429, United States

RECRUITING

Ochsner LSU Health Science Center Shreveport

Shreveport, Louisiana, 71103-4228, United States

RECRUITING

Montefiore Medical Group Family Care Center

The Bronx, New York, 10467-2410, United States

NOT YET RECRUITING

Summa Health System - Akron - 75 Arch Street

Akron, Ohio, 44304-1430, United States

RECRUITING

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

Cincinnati, Ohio, 45219, United States

RECRUITING

Prisma Health - Infectious Diseases - Greenville

Greenville, South Carolina, 29605, United States

NOT YET RECRUITING

Central Study Contacts

Reddy Tummala ISTX Clinical Trials

CONTACT

617-715-3600; Clinicaltrials@istx.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: April 28, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (8)