RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-28
Study Completion:2029-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06746883

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant is ≥18 years old at the time of written informed consent and is hospitalized.
  2. * 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).
  3. * Participant has a proven or strongly suspected diagnosis of an infection caused by susceptible ABC isolates, based on investigator's clinical judgment.
  4. * 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.
  5. * The participant has an expected survival of \>48 hours at the time of written informed consent.
  1. * A history of significant hypersensitivity or allergic reaction to any β-lactam, or any contraindication to the use of β-lactam antibiotics

Contacts and Locations

Study Contact

Reddy Tummala ISTX Clinical Trials
CONTACT
617-715-3600
Clinicaltrials@istx.com

Study Locations (Sites)

Ochsner LSU Health Science Center Shreveport
Shreveport, Louisiana, 71103-4228
United States
Prisma Health - Infectious Diseases - Greenville
Greenville, South Carolina, 29605
United States

Collaborators and Investigators

Sponsor: Innoviva Specialty Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-28
Study Completion Date2029-01-31

Study Record Updates

Study Start Date2025-04-28
Study Completion Date2029-01-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)