Assessing the safety of sulbactam-durlobactam for Acinetobacter infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the safety and risk of hypersensitivity reactions, including anaphylaxis, associated with sulbactam-durlobactam in adults diagnosed with Acinetobacter baumannii-calcoaceticus complex infections. Participants will be monitored for approximately 28 days to collect data on safety and any adverse reactions. The treatment with sulbactam-durlobactam will be administered as part of routine clinical care, independent of the study participation.

Why it matters

Who can join: the full rules

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

Where it's running

• UC Davis Health
  Sacramento, California, United States Recruiting
• University of Florida - Gainesville
  Gainesville, Florida, United States Recruiting
• Tampa General Hospital
  Tampa, Florida, United States Recruiting
• University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd
  Kansas City, Kansas, United States Recruiting
• University of Kentucky College of Medicine
  Lexington, Kentucky, United States Recruiting
• Ochsner Medical Center - New Orleans
  New Orleans, Louisiana, United States Recruiting

Study contacts

• Study coordinator: Reddy Tummala ISTX Clinical Trials
• Email: Clinicaltrials@istx.com
• Phone: 617-715-3600

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Assessing Sulbactam-Durlobactam for Pediatric Acinetobacter Infections

  This study is testing a new antibiotic combination to see if it is safe and effective for children with serious Acinetobacter infections.

  Recruiting at 4 sites Phase 1 Innoviva Specialty Therapeutics · Los Angeles, California and 3 other locations · NCT06801223

• BV100 plus low-dose polymyxin B versus colistin with high-dose ampicillin/sulbactam for hospital- or ventilator-associated pneumonia from carbapenem-resistant Acinetobacter

  This trial tests whether BV100 combined with low-dose polymyxin B helps adults with hospital- or ventilator-associated pneumonia caused by carbapenem-resistant Acinetobacter work better and be safer than colistin with high-dose ampicillin/sulbactam.

  Recruiting Phase 3 BioVersys AG · Tbilisi · NCT07326540

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.