Recruiting

Sulbactam-Durlobactam

Sponsor:

Innoviva Specialty Therapeutics

Code:

NCT06746883

Conditions

Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-interventional

Study Details

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)

Study ID

NCT06746883

Start date

Apr 28, 2025

Status verified date

Jun, 2026

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Acinetobacter baumannii-calcoaceticus complex (ABC)

Hospitalized participants with a proven or strongly suspected ABC infection who have received sulbactam-durlobactam as standard of care.

Interventions

Non-interventional

Non-interventional

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Reddy Tummala ISTX Clinical Trials

617-715-3600Clinicaltrials@istx.com

Locations

UC Davis Health

Recruiting

Sacramento, California, United States, 95817

University of Florida - Gainesville

Recruiting

Gainesville, Florida, United States, 32610-3003

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

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

Recruiting

Kansas City, Kansas, United States, 66160

University of Kentucky College of Medicine

Recruiting

Lexington, Kentucky, United States, 40536-7001

Ochsner Medical Center - New Orleans

Recruiting

New Orleans, Louisiana, United States, 70121-2429

Ochsner LSU Health Science Center Shreveport

Recruiting

Shreveport, Louisiana, United States, 71103-4228

Montefiore Medical Group Family Care Center

Recruiting

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

Summa Health System - Akron - 75 Arch Street

Recruiting

Akron, Ohio, United States, 44304-1430

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

Recruiting

Cincinnati, Ohio, United States, 45219

University of Pittsburg School of Medicine

Recruiting

Pittsburgh, Pennsylvania, United States, 15213-2500

Prisma Health - Infectious Diseases - Greenville

Recruiting

Greenville, South Carolina, United States, 29605

More Information

Sponsor

Innoviva Specialty Therapeutics

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Innoviva Specialty Therapeutics on 2026-06-24.