RecruitingNCT06746883Updated Jun 24, 2026

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

An observational study in Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC), sponsored by Innoviva Specialty Therapeutics. Recruiting at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Innoviva Specialty Therapeutics · Observational

From the registry’s dates

Started Apr 2025; still recruiting 1 year 5 months later.

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 100
Ages: 18 Years and older
Sex: All

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.

Conditions studied

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

In context

Lead sponsor

Innoviva Specialty Therapeutics is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Hospitalized participants

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

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

Observational model: Case-only
Time perspective: Prospective
Enrollment: 100 participants (estimated)
Patient registry: No

Groups and cohorts

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

OtherNon-interventional
Non-interventional

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

12 of 12 sites recruiting

UC Davis Health
Sacramento, California 95817, United States
Recruiting
University of Florida - Gainesville
Gainesville, Florida 32610-3003, United States
Recruiting
Tampa General Hospital
Tampa, Florida 33606, United States
Recruiting
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
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
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
University of Pittsburg School of Medicine
Pittsburgh, Pennsylvania 15213-2500, United States
Recruiting
Prisma Health - Infectious Diseases - Greenville
Greenville, South Carolina 29605, United States
Recruiting

References and documents

Individual participant data

Plan to share: Yes — All collected de-identified IPD may be shared

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06746883
Lead sponsor: Innoviva Specialty Therapeutics
Responsible party: Sponsor
First posted: Dec 24, 2024
Start date: Apr 28, 2025
Primary completion: Jan 31, 2029 (estimated)
Completion: Jan 31, 2029 (estimated)
Last update: Jun 24, 2026

Study contacts

Reddy Tummala ISTX Clinical Trials

Contact

Clinicaltrials@istx.com

617-715-3600

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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