Clinical Trials

Numerous clinical trials evaluate avibactam across Phase 1 through Phase 4 protocols, focusing on Gram-negative bacterial infections, carbapenem-resistant Enterobacteriaceae, sepsis, and complicated tissue or organ infections. Sponsored by pharmaceutical entities alongside academic and medical institutions, these studies range from early pharmacokinetic assessments in healthy volunteers to Phase 3 trials targeting severe infections and septic shock. Across these investigations, recruitment statuses include completed, recruiting, terminated, and withdrawn trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07759453 NOT_YET_RECRUITING
Liver Transplant; Carbapenem-resistant Enterobacterales; CRE Colonization
IRCCS Azienda Ospedaliero-Universitaria di Bologna
 2026-10-01 PHASE3
NCT07004049 RECRUITING
Bloodstream Infection; Ventilator Associated Bacterial Pneumonia; Hospital Acquired Bacterial Pneumonia; Carbapenem Resistant Bacterial Infection; Multidrug Resistance
National University of Singapore
 2025-04-21 PHASE4
NCT07327619 RECRUITING
Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia
Qilu Pharmaceutical Co., Ltd.
 2026-01-22 PHASE3
NCT07634198 NOT_YET_RECRUITING
Hospital-acquired Bacterial Pneumonia (HABP); Ventilator-associated Bacterial Pneumonia (VABP)
Nanjing Yoko Biomedical Co., Ltd.
 2026-06-04 PHASE3
NCT07431307 NOT_YET_RECRUITING
Ventilator Associated Bacterial Pneumonia (VABP); Hospital Acquired Bacterial Pneumonia (HABP); Blood Stream Infection; Meningitis, Bacterial; Ventriculitis, Infectious
BioVersys AG
 2026-07 PHASE2
NCT06939829 NOT_YET_RECRUITING
Patients With Critically Ill Infections
Southeast University, China
 2025-05-01 PHASE4
NCT07478484 RECRUITING
Ceftazidime-avibactam; Aztreonam; Gram-negative Bacterial Infection; Metallo-β-lactamase-producing; Carbapenem-resistant
Jing Zhou
 2026-03-31 PHASE4
NCT06633718 NOT_YET_RECRUITING
Intra-abdominal Infections
Qilu Pharmaceutical Co., Ltd.
 2024-10-31 PHASE3
NCT06811727 NOT_YET_RECRUITING
Severe Infection
Ivan Šitum, MD
 2025-05-01 PHASE4
NCT06462235 RECRUITING
Gram-negative Bacterial Infection
Pfizer
 2024-09-25 PHASE2
NCT05639647 RECRUITING
Gram-negative Bacterial Infections
Pfizer
 2023-04-18 PHASE2
NCT06818565 NOT_YET_RECRUITING
Acute-On-Chronic Liver Failure
Institute of Liver and Biliary Sciences, India
 2025-02-10
NCT07063095 RECRUITING
Gram Negative Infections; Sepsis and Septic Shock
Angela HUTTNER
 2025-08-25 PHASE3
NCT05979545 RECRUITING
Blood Stream Infections; Ventilator Associated Pneumonia; Healthcare Associated Infection; Carbapenem-Resistant Enterobacteriaceae Infection; Hospital-acquired Pneumonia
National University of Singapore
 2023-12-12 PHASE4
NCT06528028 UNKNOWN
Anti-Infective Agent
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
 2024-07-01 PHASE4
NCT05977868 TERMINATED
Endovascular Infection; Bone and Joint Infection; Skin and Soft Tissue Infection; Pulmonary Infection; Gastrointestinal Infection; Genitourinary Infection
West Virginia University
 2023-08-04 PHASE4
NCT05850871 UNKNOWN
Carbapenem-Resistant Enterobacteriaceae Infection
Qianfoshan Hospital
 2023-01-06
NCT06593054 COMPLETED
Healthy
Pfizer
 2024-07-29 PHASE1
NCT05340530 UNKNOWN
Infections
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
 2022-04 PHASE1
NCT04882085 COMPLETED
Urinary Tract Infection; Acute Pyelonephritis; Hospital Acquired Pneumonia; Ventilator-associated Pneumonia; Bacteremia; Intra-abdominal Infection
Pfizer
 2021-08-26 PHASE4
NCT04774094 COMPLETED
Hospital-Acquired Pneumonia
Pfizer
 2021-05-21 PHASE4
NCT05258851 TERMINATED
Carbapenem-Resistant Enterobacteriaceae Infection
King Faisal Specialist Hospital & Research Center
 2022-06-01 PHASE3
NCT03329092 COMPLETED
Complicated Intra-abdominal Infection; Hosptial Acquired Pneumonia; Ventilator Associated Pneumonia
Pfizer
 2018-04-05 PHASE3
NCT03580044 TERMINATED
Serious Bacterial Infection
Pfizer
 2020-12-25 PHASE3
NCT04785924 WITHDRAWN
Carbapenem-Resistant Enterobacteriaceae Infection; KPC; Gram-Negative Bacterial Infections; Antibiotic Resistant Infection
Wake Forest University Health Sciences
 2021-06-07 PHASE4
NCT04126031 TERMINATED
Gram-negative Bacterial Infection
Pfizer
 2020-01-14 PHASE2
NCT03790176 UNKNOWN
Peritonitis; Pneumonia
Markus Zeitlinger
 2018-10-01 PHASE1
NCT04927312 COMPLETED
Complicated Intra-abdominal Infection
Pfizer
 2021-10-01 PHASE3
NCT05588531 COMPLETED
Pharmacokinetics
Nanjing Yoko Biomedical Co., Ltd.
 2021-12-20 PHASE1
NCT04973826 COMPLETED
Healthy
Pfizer
 2021-08-20 PHASE1
NCT04486625 COMPLETED
Renal Insufficiency
Pfizer
 2020-08-10 PHASE1
NCT04040621 TERMINATED
Hospitalized Children With Suspected or Confirmed Nosocomial Pneumonia
Pfizer
 2020-06-15 PHASE1
NCT03978091 COMPLETED
Bacterial Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2019-07-09 PHASE1; PHASE2
NCT02822950 COMPLETED
Pharmacokinetics of Avycaz in ICU Patients
Michigan State University
 2017-01 PHASE1
NCT02655419 COMPLETED
Complicated Intra-Abdominal Infections, cIAIs
Pfizer
 2016-05-19 PHASE2
NCT02497781 COMPLETED
Complicated Urinary Tract Infections
Pfizer
 2015-09-24 PHASE2
NCT02475733 COMPLETED
Complicated Intra-abdominal Infections
Pfizer
 2015-08-01 PHASE2
NCT02504827 COMPLETED
Cystic Fibrosis
University of Southern California
 2015-09 PHASE4
NCT02732327 TERMINATED
Neoplasms; Febrile Neutropenia
Forest Laboratories
 2016-05-17 PHASE2
NCT01808092 COMPLETED
Nosocomial Pneumonia (NP); Ventilator-associated Pneumonia (VAP)
Pfizer
 2013-04 PHASE3
NCT01726023 COMPLETED
Complicated Intra-abdominal Infection
Pfizer
 2013-01 PHASE3
NCT01689207 COMPLETED
Complicated Infection; Bacterial Infections
Pfizer
 2012-09 PHASE1
NCT01893346 COMPLETED
Systemic Infections
Pfizer
 2013-07 PHASE1
NCT01644643 COMPLETED
Complicated Urinary Tract Infection; Complicated Intra-abdominal Infection
Pfizer
 2013-01 PHASE3
NCT01599806 COMPLETED
Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Pfizer
 2012-10 PHASE3
NCT01595438 COMPLETED
Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Pfizer
 2012-10 PHASE3
NCT01499290 COMPLETED
Complicated Intra-Abdominal Infection
Pfizer
 2012-03 PHASE3
NCT01920399 COMPLETED
Healthy Volunteers
Pfizer
 2013-10 PHASE1
NCT01624246 COMPLETED
Augmented Renal Clearance (ARC); Systemic Inflammatory Response Syndrome (SIRS)
Forest Laboratories
 2012-05 PHASE1
NCT01430910 COMPLETED
Healthy
Pfizer
 2011-09 PHASE1
NCT01395420 COMPLETED
Healthy
Pfizer
 2011-08 PHASE1
NCT01534247 COMPLETED
Healthy
Pfizer
 2012-02 PHASE1
NCT01448395 Completed
Healthy
Pfizer
 2011-10 Phase 1
NCT01291602 Completed
Healthy Male and Female Japanese Volunteers
Pfizer
 2011-02 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-08-12)

Check the Avibactam sodium product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Avibactam acts as a covalent, reversible, non-beta-lactam inhibitor that binds serine beta-lactamases, preventing enzymatic inactivation of co-administered beta-lactam antibiotics. By blocking hydrolytic breakdown and preserving antibiotic activity within bacterial cells, it restores antibacterial efficacy against multidrug-resistant pathogens, rendering it clinically relevant for treating carbapenem-resistant Enterobacteriaceae and severe Gram-negative bacterial infections.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.