Assessing the safety of sulbactam-durlobactam for Acinetobacter infections
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
This study is testing if the medication sulbactam-durlobactam is safe for adults with Acinetobacter infections and if it causes any allergic reactions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Innoviva Specialty Therapeutics Industry-sponsored |
| Locations | 8 sites (Kansas City, Kansas and 7 other locations) |
| Trial ID | NCT06746883 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults aged 18 and older with a confirmed or strongly suspected Acinetobacter baumannii-calcoaceticus complex infection.
Not a fit: Patients who do not have a confirmed or suspected ABC infection or those who are not hospitalized may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical safety data that may enhance treatment protocols for patients with Acinetobacter infections.
How similar studies have performed: While this approach is observational, similar studies evaluating the safety of antibiotic treatments have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Kansas City, Kansas and 7 other locations
- 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 (Not_yet_recruiting)
- Ochsner Medical Center - New Orleans — New Orleans, Louisiana, United States (Recruiting)
- Ochsner LSU Health Science Center Shreveport — Shreveport, Louisiana, United States (Recruiting)
- Montefiore Medical Group Family Care Center — The Bronx, New York, United States (Not_yet_recruiting)
- Summa Health System - Akron - 75 Arch Street — Akron, Ohio, United States (Recruiting)
- The Carl and Edyth Lindner Center for Research and Education at Christ Hospital — Cincinnati, Ohio, United States (Recruiting)
- Prisma Health - Infectious Diseases - Greenville — Greenville, South Carolina, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Reddy Tummala ISTX Clinical Trials
- Email: Clinicaltrials@istx.com
- Phone: 617-715-3600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.