Xacduro (sulbactam-durlobactam) / ZAI Lab, Innoviva - LARVOL DELTA

A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Innoviva Specialty Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Infectious Disease

New β-Lactam/β-Lactamase Inhibitor Combination Antibiotics. (PubMed, Pathogens) - "During the last 2 years from the writing of this article, cefepime/enmetazobactam, aztreonam/avibactam, and sulbactam/durlobactam were approved for use in clinical practice. Aztreonam/avibactam is indicated for the treatment of adult patients who suffer from complicated intra-abdominal infections, complicated urinary tract infections including pyelonephritis, hospital-acquired pneumonia, and ventilator-associated pneumonia due to aerobic Gram-negative infections with limited therapeutic options. Sulbactam/durlobactam, a combination of 2 β-lactamase inhibitors, is indicated for the treatment of adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia due to the Acinetobacter baumannii-calcoaceticus complex [including carbapenem-resistant Acinetobacter baumannii (CRAB) infections]."

Journal • Review • Infectious Disease • Nephrology • Pneumonia • Respiratory Diseases

Quantification of sulbactam and durlobactam in saline and human plasma via ultra-performance liquid chromatography tandem mass spectrometry. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci) - "The standard curves for each drug were linear over the range 0.5 to 50 μg/mL and use the isotopic analogs sulbactam-d5 and [13C2, 15N2]-durlobactam as internal standards for their respective analytes. This simple, reproducible method for the determination of sulbactam and durlobactam concentrations was developed with the intent to conduct future pharmacokinetic analyses and to guide clinical laboratories in the development of a therapeutic drug monitoring assay."

Journal • Infectious Disease • Pneumonia • Respiratory Diseases

Pharmacokinetic and pharmacodynamic evaluation of sulbactam-durlobactam in a critically ill patient on continuous venovenous hemofiltration infected with carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex. (PubMed, Pharmacotherapy) - "Sulbactam-durlobactam monotherapy dosed at 2 g every 4 h (3-h infusion) in CVVH achieved PD targets for this CRAB isolate with a MIC of 4/4 mcg/ml. Although sulbactam-durlobactam monotherapy resulted in initial microbiological clearance for the CRAB bacteremia, recurrence occurred, and the patient ultimately died."

Journal • PK/PD data • Infectious Disease • Pneumonia • Respiratory Diseases

Evolution of an extensively antibiotic resistant sublineage of lineage 1 of GC1 Acinetobacter baumannii. (PubMed, NPJ Antimicrob Resist) - "The blaNDM and blaPER genes contribute to reduced susceptibility to cefiderocol and/or sulbactam/durlobactam. The phylogeny indicated that separation of the sublineage into KL1 and KL17 groups coincided with the KL switch and Aci-IE1 was acquired later."

Journal

Successful Combination Therapy with Cefiderocol and Sulbactam-Durlobactam for Donor-Derived Carbapenem-Resistant Acinetobacter baumannii in a Kidney Transplant Recipient. (PubMed, Transpl Infect Dis) - No abstract available

Journal • Solid Organ Transplantation • Transplantation

Genomic characterization of Carbapenem-Resistant Acinetobacter baumannii clinical strains resistant to Sulbactam/Durlobactam from Italy. (PubMed, Eur J Clin Microbiol Infect Dis) - No abstract available

Journal

Critical reappraisal of current issues for improving the proper clinical use of the incoming beta-lactam/beta-lactamase inhibitor combinations of tomorrow. (PubMed, Expert Rev Anti Infect Ther) - "A literature search was performed on PubMed-MEDLINE (until December 2024) for retrieving available studies on cefepime-enmetazobactam, sulbactam-durlobactam, and cefepime-taniborbactam. Overall, old habits die hard and issues retrieved with licensed beta-lactams emerged also with novel BL/BLIc of tomorrow, potentially affecting their efficacy when used in real-world practice. Adopting appropriate corrective measures for overcoming these issues might increase the likelihood of preserving their efficacy in the future by minimizing the propensity risk of resistance development."

Clinical • Journal • Infectious Disease • Nephrology • Pneumonia • Renal Disease • Respiratory Diseases

Sulbactam for carbapenem-resistant Acinetobacter baumannii infections: a literature review. (PubMed, JAC Antimicrob Resist) - "The aim of this review is to analyse primary and secondary research studies that compare sulbactam-based with other regimens, such as polymyxin-containing regimens, tigecycline-containing regimens and other antimicrobial combinations against CRAB infections, especially ventilator-associated pneumonia (VAP), hospital-acquired pneumonia (HAP) and bacteraemia...The auspicious novel β-lactam/β-lactamase inhibitor combination sulbactam/durlobactam is also discussed, although real-world clinical data regarding its efficacy in CRAB infections are still scarce. More randomized controlled trials comparing sulbactam-based with other regimens are warranted to determine the most effective antimicrobial combination against CRAB infections. Nevertheless, current data suggest that sulbactam could play a major role in this combination treatment."

Journal • Review • Infectious Disease • Pneumonia • Respiratory Diseases

Are cefiderocol or sulbactam/durlobactam better than alternative best available treatment for infection by carbapenem-resistant A. baumannii? A systematic literature review. (PubMed, Infection) - "High-quality evidence supporting use of either CFDC or SUL/DUR in favor of high-dose AMP/SUL-based regimens is lacking. This has important stewardship implications. Additionally, both CFDC and SUL/DUR are much more expensive than AMP/SUL, an important consideration especially for low-/mid-income countries. Studies comparing CFDC- and SUL/DUR-based treatments to contemporary alternative BAT are needed."

Journal • Review • Infectious Disease • Pneumonia • Respiratory Diseases

Management of Severe Infections: Multidrug-Resistant and Carbapenem-Resistant Gram-Negative Bacteria. (PubMed, Med Clin North Am) - "For Enterobacterales, it highlights the relative advantages of meropenem-vaborbactam and imipenem-relebactam in treating Klebsiella pneumoniae carbapenemase (KPC)-producing strains with resistance to ceftazidime-avibactam, the preference for ceftazidime-avibactam in addressing oxacillin-hydrolyzing carpapenemase (OXA)-48-like -producing organisms, and the combination of ceftazidime-avibactam with aztreonam for metallo-β-lactamase (MBL)-producing Enterobacterales. Regarding A baumannii, sulbactam-durlobactam is identified as the preferred treatment, while ceftolozane-tazobactam, ceftazidime-avibactam, and imipenem-relebactam are viable options for P aeruginosa. Additionally, cefiderocol is presented as an alternative for MBL-producing carbapenem-resistant gram-negative bacteria."

Journal • Review • Infectious Disease • Pneumonia

A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Innoviva Specialty Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pediatrics

A single centre review of sulbactam/durlobactam for the treatment of serious Acinetobacter baumannii infections (ESCMID Global 2025) - No abstract available

Clinical • Review • Infectious Disease

Interplay between sulbactam/durlobactam and imipenem against penicillin-binding proteins (PBPs) of Acinetobacter spp. (ESCMID Global 2025) - No abstract available

In vitro activity of sulbactam/durlobactam against clinical Acinetobacter baumannii isolates in China (ESCMID Global 2025) - No abstract available

Preclinical

In vitro susceptibility to sulbactam/durlobactam of carbapenem-resistant Acinetobacter baumannii isolated from bloodstream infections: a multicentre study in Brazil (ESCMID Global 2025) - No abstract available

Preclinical • Infectious Disease

Evaluation of the susceptibility of Carbapenem-resistant Acinetobacter baumannii to sulbactam-durlobactam (ESCMID Global 2025) - No abstract available

Prevalence and genomic characterization of Sulbactam-Durlobactam-resistant and Carbapenem-resistant Acinetobacter baumannii in ICU Patients in a tertiary hospital in Hanoi, Northern Vietnam (ESCMID Global 2025) - No abstract available

Clinical

Sulbactam-durlobactam as an effective alternative option against NDM-producing Escherichia coli including cefiderocol and aztreonam-avibactam-resistant isolates in Swizterland (ESCMID Global 2025) - No abstract available

Fighting resistance with redundancy: a path forward for treating antimicrobial-resistant infections? (PubMed, Antimicrob Agents Chemother) - "Sulbactam-durlobactam was combined with imipenem-cilastatin in a clinical trial that led to its United States Food and Drug Administration approval. However, the additive benefit of imipenem remains uncertain. In a recent study (Antimicrob Agents Chemother 69:e01627-24, 2025, https://doi.org/10.1128/aac.01627-24), Veeraraghavan and colleagues provide convincing mechanistic evidence that adding imipenem to sulbactam-durlobactam enhances bacterial killing, likely through complementary inhibition of penicillin binding proteins, leveraging the concept of target redundancy."

Journal • Infectious Disease

A microbiological and structural analysis of the interplay between sulbactam/durlobactam and imipenem against penicillin-binding proteins (PBPs) of Acinetobacter spp. (PubMed, Antimicrob Agents Chemother) - "In the ATTACK Phase 3 trial examining the efficacy of sulbactam (SUL)/durlobactam (DUR) to treat primarily Acinetobacter baumannii complex (ABC) infections, imipenem (IPM)/cilastatin was added as a common therapy to both the SUL/DUR and the comparator colistin arms. Molecular docking analysis of OXA carbapenemase enzymes with DUR also revealed favorable interactions. Although clinical trials are warranted, these analyses provide mechanistic support for the addition of IPM to SUL/DUR."

Journal • Infectious Disease

Acinetobacter baumannii Complex Infections: New Treatment Options in the Antibiotic Pipeline. (PubMed, Microorganisms) - "Furthermore, many older agents, such as polymyxin and colistin, have limited lung penetration and are associated with significant toxicities. In order to place these newer molecules in context and to help clinicians appreciate the emerging potential drug development pipeline, we describe the in vitro activity, mechanisms of action, and clinical trial data not only for the commercially now available alternatives, such as cefiderocol and sulbactam-durlobactam, but also review these topics for molecules undergoing phase II and III clinical trials. Specifically, we discuss and analyze data related to four novel drugs from ABC: BV-100, cefepime-zidebactam, zosurabalpin, and OMN6."

Journal • Review • Infectious Disease • Pneumonia • Respiratory Diseases • Septic Shock

β-Lactam/β-Lactamase Inhibitor Combination Antibiotics Under Development. (PubMed, Pathogens) - "The incorporation of ceftolozane/tazobactam, ceftazidime/avibactam, meropenem/vaborbactam, and imipenem/cilastatin/relebactam has provided new therapeutic options in the treatment of patients with infections due to MDR pathogens. Cefiderocol along with cefepime/enmetazobactam, avibactam/aztreonam, and sulbactam/durlobactam have been recently added to these agents as therapeutic choices, particularly for metallo-β-lactamase producing Gram-negative bacteria...However, only a few have advanced through phase 1, 2, and 3 clinical trials. Among them, in this article, we focus on the most promising combinations of cefepime/zidebactam, cefepime/taniborbactam, and imipenem/cilastatin/funobactam, which are currently under investigation in phase 3 trials."

Journal • Review • Infectious Disease

The Effectiveness of Newer Beta-Lactams for the Treatment of Antimicrobial-Resistant Gram-Negative Meningitis. (PubMed, Clin Infect Dis) - "Several newer β-lactam agents with activity against DTR gram-negatives are available including cefiderocol, ceftazidime-avibactam, ceftolozane-tazobactam, imipenem-cilastatin-relebactam, meropenem-vaborbactam, and sulbactam-durlobactam. In this article, we review host and drug factors that influence an antibiotic's likely effectiveness for the treatment of bacterial meningitis. We also review the preclinical and clinical data in support of or against each of the aforementioned agents for the treatment of bacterial meningitis."

Journal • CNS Disorders • Infectious Disease

Sulbactam-Durlobactam: A Novel Antibiotic Combination for the Treatment of Acinetobacter baumannii-Calcoaceticus Complex (ABC) Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia. (PubMed, Can J Infect Dis Med Microbiol) - "ATTACK, a phase III clinical trial of sulbactam-durlobactam, studied the safety and efficacy of sulbactam-durlobactam in patients with ABC HABP/VABP and showed its noninferiority to colistin. Sulbactam-durlobactam is a new β-lactamase inhibitors combination active against MDR Gram-negative bacteria including ABC. It is currently approved for the treatment of HABP/VABP caused by susceptible ABC strains."

Journal • Review • Dermatology • Hematological Disorders • Immunology • Infectious Disease • Nephrology • Pain • Pneumonia • Respiratory Diseases • Urticaria