Welcome to What's it Worth! Join your host Dr. Diana Langworthy, & co-host Marina Fahim, as we ATTACK the critique of a non-inferiotiy study design. Our expert guest for this episode is Dr. Betsy Hirsch, Assoiate Professor and Infectious Diseases Translational Researcher. We're discussing a trial that compared a new beta-lactam antibiotic, sulbactam/durlobactam, with colistin for the treatment of Acinetobacter baumannii infections. Join us as we discuss the key points of a non-inferiority trial design as we determine what this article is worth!

Key Points

1. Non-inferiority (NI) trials are indicated when there are other effective treatment options or where it would unethical to expose a group to placebo
2. Acinetobacter baumannii-calcoaceticus (ABC) is seen in hospital acquired infections and presents a clinical challenge to practitioners given its increasing resistance patterns
3. NI margins are important components to critique when reviewing these trials to determine clinical implications and whether the margin is clinically justifiable 
4. How inferior is considered "non-inferior"? --> Tune in to find out!

References

1. [EPISODE TRIAL] Kaye KS, Shorr AF, Wunderink RG, et al.  Efficacy and safety of sulbactam-durlobactam versus colistin for the treatment of patients with serious infections caused by Acinetobacter baumannii-calcoaceticus complex:  a multicentre, randomised, active-controlled, phase 3, non-inferiority clinical trial (ATTACK).  Lanced Infect Dis 2023; Sep;23(9):1072-1084.  doi: 10.1016/S1473-3099(23)00184-6.
2. Tamma PD, Aitken SL, Bonomo RA, et al.  Infectious Diseases Society of America 2023 Guidance on the Treatment of Antimicrobial Resistant Gram-Negative Infections. CID 2023, ciad428,  https://doi.org/10.1093/cid/ciad428
3.  Product Information: XACDURO(R) intravenous kit, sulbactam, durlobactam intravenous kit. La Jolla Pharmaceutical Company (per manufacturer), Waltham, MA, 2023.
4. Tsuji BT, Pogue JM, Zavascki AP, et al.  International Consensus Guidelines for the Optimal Use of the Polymyxins: Endorsed by the American College of Clinical Pharmacy (ACCP), European Society of Clinical Microbiology and Infectious Diseases (ESCMID), Infectious Diseases Society of America (IDSA), International Society for Anti-Infective Pharmacology (ISAP), Society of Critical Care Medicine (SCCM), and Society of Infectious Diseases Pharmacists (SIDP).  Pharmacotherapy 2019;39(1):10-39.  https://accpjournals.onlinelibrary.wiley.com/doi/full/10.1002/phar.2209

Contact Information

Podcast email: whatsitworthpodcast@gmail.com

Host Information

Dr. Diana R. Langworthy, PharmD, BCPS

Clinical Associate Professor, University of Minnesota College of Pharmacy

Clinical Pharmacist - Inpatient Internal Medicine, M Health Fairview East Bank Hospital

Co-Host Information

Marina Fahim, Student Pharmacist, Class of 2024  University of Minnesota

Guest Host Information

Dr. Betsy Hirsch, PharmD, FCCP, FIDSA

Associate Professor, Experimental and Clinical Pharmacology

Infectious Diseases Translational Researcher

University of Minnesota College of Pharmacy