Pharmacokinetic, pharmacodynamic, and efficacy of ceftazidime-avibactam in Meningitis or ventriculitis patients caused by carbapenem resistant Enterobacteriaceae : a prospective, multi-center clinical study

Start Date01 Nov 2025

Sponsor / Collaborator

Shanghai Huashan Hospital

ChiCTR2600117034

/ SuspendedPhase 4IIT

Clinical study on the monotherapy and combination therapy of ceftazidime-avibactam for carbapenem-resistant Gram-negative bacteria (CRO) infection

Start Date20 Oct 2025

Sponsor / Collaborator

First People's Hospital of Yunnan Province

100 Clinical Results associated with Avibactam sodium

100 Translational Medicine associated with Avibactam sodium

100 Patents (Medical) associated with Avibactam sodium

2,337

Literatures (Medical) associated with Avibactam sodium

31 Dec 2026·Emerging Microbes & Infections

Spread of carbapenemase-producing Serratia spp. in France from 2016 to 2024: a comparative genomic study

Article

Author: Jousset, Agnès B. ; Emeraud, Cécile ; Bonnin, Rémy A. ; Larouy-Maumus, Gerald ; Dortet, Laurent ; Ouacel, Kenza ; Bernabeu, Sandrine ; Rezzoug, Inès ; Birer, Aurelien

Carbapenemase-producing Serratia spp. are increasingly implicated in healthcare-associated infections. This study aimed to characterize the genetic diversity, resistance mechanisms, and susceptibility to last resort antimicrobials of carbapenem-resistant Serratia spp. in France. From 2016 to 2024, 193 carbapenemase-producing Serratia spp. from France were investigated. WGS enabled species identification, MLST typing, resistome characterization and phylogenetic analysis. Antimicrobial susceptibility was assessed by broth microdilution, focusing on last resort antimicrobials. Intrinsic resistance to polymyxins was explored by genomic analysis and lipid A mass spectrometry. S. sarumanii (54%) and S. nevei (41%) dominated the epidemiology while no S. marcescens was identified. The most prevalent carbapenemases were OXA-48-like (56%), NDM (25%), IMP (8%), and VIM (7%). MLST identified 67 sequence types (ST) with 42% of the isolates belonging to four high-risk clones: ST-601, ST-298, ST-477, ST-600 and ST-474. β-lactamse susceptibility was low, but aztreonam-avibactam remained highly active (98%). Intrinsic resistance to polymyxin did not result from lipid A modifications as reported for Proteae. In France, carbapenemase-producing Serratia spp. were dominated by S. sarumanii and S. nevei. The absence of S. marcescens, the genus leader, highlighted the need to update the MALDI-TOF database. This study highlights Serratia as an underestimated reservoir of multidrug resistance.

31 Dec 2026·Journal of Pharmaceutical Policy and Practice

Effectiveness and safety of ceftazidime/avibactam versus polymyxin B in liver transplant recipients with carbapenem-resistant organism infections: a real-world cohort study

Article

Author: Zhou, Zhengdon ; Chen, Chuanlin ; Hu, Yongfang ; Sheng, Bo ; Zhang, Weiwei ; Zhang, Zhenyu ; Li, Desheng

Background:

Treatment options for carbapenem-resistant organism (CRO) infections remain limited, with ceftazidime/avibactam (CAZ/AVI) and polymyxin B (PMB) being the main therapeutic choices. However, comparative evidence regarding the efficacy and safety of liver transplant (LT) recipients is scarce.

Methods:

This single-center retrospective cohort study was conducted in the liver intensive care unit of Beijing Tsinghua Changgung Hospital from January 2018 to December 2024. Adult LT recipients with CRO infections who received intravenous CAZ/AVI or PMB for > 48 h were included. Propensity score matching (PSM) was performed at a 1:1 ratio to balance baseline variables. Logistic regression analyses were used to evaluate microbial clearance, clinical success, and acute kidney injury (AKI). Cox proportional hazards models assessed the 90-day all-cause mortality and factors associated with survival outcomes.

Results:

Among the 106 LT recipients with postoperative CRO infections, 45 received CAZ/AVI (n = 23) or PMB (n = 22). After PSM, 22 patients were included in each group. The rates of microbial clearance (59.1% vs. 63.6%), clinical success (54.6% vs. 54.6%), and 90-day all-cause mortality (22.7% vs. 27.3%) were comparable between the CAZ/AVI and PMB (p > 0.05). However, AKI occurred significantly more frequently in the PMB group than in the CAZ/AVI group (81.8% vs. 50.0%, p = 0.026). Complete withdrawal of immunosuppressive therapy was independently associated with increased 90-day mortality (hazard ratio [HR] = 4.46, 95% CI 1.29-15.35, p = 0.018).

Conclusion:

CAZ/AVI and PMB achieved similar clinical effectiveness and survival outcomes in LT recipients with CRO infections; however, PMB carries a higher risk of nephrotoxicity. Discontinuation of immunosuppressive therapy during infection significantly affects patient survival. These findings highlight the importance of individualised antimicrobial selection, renal safety monitoring, and pharmacist-led stewardship in managing CRO infections in liver transplant patients.

01 Dec 2026·BRAZILIAN JOURNAL OF MICROBIOLOGY

DOT-MGA for rapid determination of susceptibility to the combination of Ceftazidime-avibactam and Aztreonam among Enterobacterales

Article

Author: Caireão, Juliana ; da Silva Collar, Gabriela ; Becker, Julia ; Mott, Mariana Preussler ; Barth, Afonso Luís ; Barth, Patricia Orlandi ; Rodrigues, Clara Gubert ; Moreira, Natália Kehl

News (Medical) associated with Avibactam sodium

15 Apr 2026

·www.biospace.com

Meiji Seika Pharma’s Nacubactam to Be Featured in 10 Presentations at ESCMID Global 2026 — Including Phase III Integral-2 Results

TOKYO--(BUSINESS WIRE)--Meiji Seika Pharma Co., Ltd. (headquartered in Tokyo; President and Representative Director: Toshiaki Nagasato) today announced that at ESCMID Global 2026, to be held from 17 to 21 April 2026, it will present a total of ten studies on its novel β-lactamase inhibitor nacubactam (development code: OP0595), for which a manufacturing and marketing authorisation application is under review in Japan. The presentations include results from Integral-2, an international, multicentre Phase III clinical trial in patients with infections due to carbapenem-resistant Enterobacterales (CRE). Currently, carbapenem-resistant bacteria pose a global threat because carbapenems are considered last-resort agents for severe infections. The development and approval of effective agents against multidrug-resistant Gram-negative bacteria, including CRE, are urgently needed ( WHO Bacterial Priority Pathogens List, 2024 ). In December 2025, Meiji Seika Pharma submitted an application for manufacturing and marketing approval of nacubactam in Japan and remains committed to contributing to global efforts against AMR—the “silent pandemic.” The planned presentations are as follows: Efficacy and safety of cefepime/nacubactam and aztreonam/nacubactam vs best available therapy in adults with cUTI/AP, HABP/VABP, cIAI due to carbapenem resistant Enterobacterales: Integral-2, single-blind, randomised phase III trial — Oral presentation (O0107); Clinical Outcomes of cefepime/nacubactam and aztreonam/nacubactam for treatment of cUTI/AP patients with CRE: subgroup analysis of Integral-1 study — Poster (P2876); Poster Walkthrough (R0058); Clinical Outcomes of cefepime/nacubactam and aztreonam/nacubactam in cUTI/AP patients with ESBL-producing bacteria enrolled into prospective phase III randomised clinical study (Integral-1) — Poster (P2864); Clinical Efficacy and safety of cefepime/nacubactam and aztreonam/nacubactam compared with imipenem/cilastatin for complicated urinary tract infection or acute uncomplicated pyelonephritis: Integral-1, a double-blind, randomised phase III trial — Poster (P2857); Clinical The in vitro activity of aztreonam/nacubactam and cefepime/nacubactam against molecularly characterised Enterobacterales isolates including those with ceftazidime-avibactam and aztreonam/avibactam resistance mechanisms collected globally from 2021–2023 — Top Rated Poster (P1622); Non-clinical Activity of the novel combination therapy cefepime/nacubactam against 17,220 clinical isolates of Enterobacterales collected worldwide during 2021–2024 — Poster (P1197); Non-clinical In vitro activity of nacubactam against broad-spectrum β-lactamases — Poster (P2659); Non-clinical Probability of target attainment of cefepime/nacubactam and aztreonam/nacubactam for carbapenem-resistant Enterobacterales infections — Poster (P2742); PK/PD Population pharmacokinetic analysis of nacubactam, cefepime, and aztreonam and exposure–response analysis of efficacy results from phase III clinical trials — Poster (P2743); PK/PD Determination of the nonclinical PK/PD target value for nacubactam in a mouse thigh infection model using carbapenem-resistant Enterobacterales under co-administration of cefepime or aztreonam — Poster (P2744); PK/PD Following congress selection, O0107 was chosen for an Oral Presentation, P2876 for the Poster Walkthrough session, and P1622 as a Top Rated Poster (top 2%). About nacubactam (development code: OP0595) Nacubactam (development code: OP0595) is a novel β-lactamase inhibitor discovered by Meiji Seika Pharma. In combination with existing β-lactam antibiotics such as cefepime or aztreonam, nacubactam is expected to be effective against carbapenem-resistant Enterobacterales (CRE), including carbapenemase-producing strains. In addition, nacubactam inhibits penicillin-binding protein 2 (PBP2), an enzyme involved in the biosynthesis of peptidoglycan in the bacterial cell wall, thereby conferring a property that distinguishes it from other β-lactamase inhibitors. In the Integral-1 trial, for the primary endpoint of composite clinical and microbiological response at seven days after the end of treatment, superiority of cefepime/nacubactam over imipenem/cilastatin and non-inferiority of aztreonam/nacubactam to the same comparator were demonstrated. With respect to safety, no significant safety concerns were observed (press release dated 14 March 2025). In the Integral-2 trial, for the primary endpoint of overall composite response at seven days after the end of treatment across all enrolled indications, high efficacy of both cefepime/nacubactam and aztreonam/nacubactam was confirmed compared with best available therapy. With respect to safety, no significant safety concerns were observed. Contacts For further information: Meiji Seika Pharma Co., Ltd. Hayato Okade Project Manager, Nacubactam pr-pharma@meiji.com

09 Jan 2026

·www.adalvo.com

Adalvo completes DCP submission for Ceftazidime + Avibactam

Adalvo submitted the dossier for Ceftazidime + Avibactam (2 g/0.5 g) powder for solution for infusion on December 31st, 2025. Based on the reference brands, Zavicefta (EU) and Avycaz (US), the antibiotic combination is indicated for three serious bacterial infections: complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI) including pyelonephritis, and Hospital-Acquired Pneumonia (HAP) including Ventilator-Associated Pneumonia (VAP). The niche antibiotic combination product is on a growing sales trajectory. According to IQVIA, global MAT sales reached $535 million in 2023, with a 3-year CAGR of 6%. As a complex antibiotic therapy, Ceftazidime + Avibactam represents a significant technical accomplishment for Adalvo. Both the active pharmaceutical ingredient (API) and finished dosage form (FDF) are difficult to manufacture, and little competition is expected. Furthermore, Adalvo has secured one of the few API sources on Earth. The company remains on target for a Day-1 launch in key markets, reaffirming its commitment to providing high-quality, affordable medicines for critical healthcare needs. To discuss licensing opportunities or to see Adalvo’s full infectiology portfolio, contact a member of the team today.

Qualified Infectious Disease Product

01 May 2025

·pmlive.com

UK government’s AMR study highlights importance of appropriate antibiotic use

The UK Health Security Agency (UKHSA) has found that some bacteria have already developed resistance to ceftazidime/avibactam, an antibiotic that was only introduced to the NHS in 2017. Despite the levels of resistance to ceftazidime/avibactam being low, the government agency said the findings from its study are an “important reminder” to ensure that antibiotics are used appropriately. Responsible for an estimated 1.27 million deaths globally in 2019, antimicrobial resistance (AMR) occurs when bacteria, viruses, fungi and parasites change over time and find ways to resist the effects of antibiotics and other antimicrobial drugs. As a result, infections become harder to treat and the risk of serious complications and death increases. Although AMR occurs naturally, the use of antibiotics accelerates the process. Ceftazidime/avibactam is used to treat some of the most serious infections in hospitals, usually after other antibiotics have failed or in patients who are infected with known multi-drug resistant bacteria. It is classed as a ‘reserve’ antibiotic, meaning it should be prescribed only in exceptional circumstances. After analysing data from 2016 to 2020, the UKHSA found that 6.3% of bacteria tested in routine surveillance showed resistance to ceftazidime/avibactam. Percentage resistance per bacterial species was shown to vary over time and stabilised as routine surveillance testing was established. Colin Brown, UKHSA deputy director responsible for AMR, said: “Research like this means clinicians and prescribers can access the most relevant information available to prescribe the best antibiotics for their patients, while protecting the long-term effectiveness of antibiotics for future use. “We aren’t going to be able to tackle antibiotic resistance solely by finding new drugs. While we continue to support innovation in developing new treatments, resistance will emerge and so it’s important that we all work together to keep antibiotics working.” The UK government has a focus on tackling AMR. In May 2024, it announced the launch of a new five-year AMR national action plan committing the UK to reducing its use of antimicrobials. The commitments outlined in the plan also included strengthening the surveillance of drug-resistant infections before they emerge, supporting low- and middle-income countries to respond to the threat of AMR and incentivising the development of new vaccines, diagnostics and therapeutics, including alternatives to antimicrobials.

100 Deals associated with Avibactam sodium

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bacteremia	Phase 3	United States	Pfizer Inc.	25 Dec 2020
Bacteremia	Phase 3	Greece	Pfizer Inc.	25 Dec 2020
Bacteremia	Phase 3	India	Pfizer Inc.	25 Dec 2020
Bacteremia	Phase 3	Russia	Pfizer Inc.	25 Dec 2020
Complicated intra-abdominal infection	Phase 3	United States	Pfizer Inc.	25 Dec 2020
Complicated intra-abdominal infection	Phase 3	Greece	Pfizer Inc.	25 Dec 2020
Complicated intra-abdominal infection	Phase 3	India	Pfizer Inc.	25 Dec 2020
Complicated intra-abdominal infection	Phase 3	Russia	Pfizer Inc.	25 Dec 2020
Complicated lower urinary tract infection	Phase 3	United States	Pfizer Inc.	25 Dec 2020
Complicated lower urinary tract infection	Phase 3	Greece	Pfizer Inc.	25 Dec 2020

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