Numerous clinical trials, spanning Phase I through Phase IV, evaluate the efficacy, safety, and pharmacokinetics of ceftazidime alone or combined with beta-lactamase inhibitors like avibactam. Sponsored by academic medical centers, health systems, and pharmaceutical companies, these studies target carbapenem-resistant Enterobacteriaceae infections, melioidosis, hospital-acquired and ventilator-associated pneumonia, complicated intra-abdominal or urinary tract infections, and severe sepsis. The trials exhibit varying recruitment statuses, including completed, actively recruiting, not yet recruiting, and withdrawn.
| 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 |
| NCT06406114 | RECRUITING | Drug Allergy; Cephalosporin Allergy; Drug Hypersensitivity; Antibiotic Allergy; Beta Lactam Adverse Reaction; Drug-Induced Anaphylaxis; Cephalosporin Reaction |
Massachusetts General Hospital |
2025-05-05 | PHASE2 |
| 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 |
| 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 |
| NCT07085624 | NOT_YET_RECRUITING | Infection in ICU; Sepsis; Septic Shock; Pseudomonas Aeruginosa Infection |
Centre Hospitalier Universitaire de Saint Etienne |
2026-01 | |
| 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 |
| NCT04948463 | COMPLETED | Febrile Neutropenia |
Murdoch Childrens Research Institute |
2021-11-15 | PHASE4 |
| NCT07016165 | RECRUITING | Neutropenic Fever; Acute Lymphoblastic Leukemia; Acute Myeloblastic Leukemia; Non Hodgkin Lymphoma |
Gadjah Mada University |
2025-06-01 | 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 | |
| NCT06210542 | Not yet recruiting | ECMO|Carbapenem-Resistant Enterobacteriaceae Infection |
Sichuan Provincial People''s Hospital |
2024-01 | -- |
| NCT06089668 | Recruiting | Melioidosis |
AN2 Therapeutics Inc|Mahidol Oxford Tropical Medicine Research Unit |
2023-11-01 | -- |
| NCT05105035 | COMPLETED | Melioidosis |
Arrevus Inc. |
2022-06-14 | PHASE2 |
| 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 |
| 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 |
| NCT05487586 | Recruiting | Hospital Acquired Pneumonia|Ventilator Acquired Pneumonia|Complicated Intra Abdominal Infections |
Pfizer |
2022-10-20 | -- |
| NCT04927312 | COMPLETED | Complicated Intra-abdominal Infection |
Pfizer |
2021-10-01 | PHASE3 |
| NCT01601093 | SUSPENDED | Respiratory Tract Infections; Urinary Tract Infections |
Xiangbei Welman Pharmaceutical Co., Ltd |
2011-11 | PHASE2 |
| NCT05413343 | Recruiting | Severe Sepsis |
First Affiliated Hospital of Zhejiang University |
2022-01-01 | -- |
| NCT04927312 | Completed | Complicated Intra-abdominal Infection |
Pfizer |
2021-10-01 | Phase 3 |
| NCT04040621 | TERMINATED | Hospitalized Children With Suspected or Confirmed Nosocomial Pneumonia |
Pfizer |
2020-06-15 | PHASE1 |
| NCT03754387 | UNKNOWN | Chronic Appendicitis |
Zunyi Medical College |
2019-01-01 | |
| NCT03978091 | COMPLETED | Bacterial Infection |
National Institute of Allergy and Infectious Diseases (NIAID) |
2019-07-09 | PHASE1; PHASE2 |
| NCT03634904 | UNKNOWN | Bacterial Infections; Ceftazidime; Renal Failure Chronic Requiring Hemodialysis |
Centre Hospitalier Universitaire de Charleroi |
2018-09-15 | |
| NCT04187755 | COMPLETED | Neutropenia, Febrile; Leukemia; Pediatric Cancer; Antibiotic Reaction |
Indonesia University |
2019-03-01 | PHASE4 |
| NCT02593201 | COMPLETED | Peritoneal Dialysis |
Chinese University of Hong Kong |
2016-02-26 | PHASE4 |
| NCT03404739 | UNKNOWN | Esophageal Achalasia |
Shanghai Zhongshan Hospital |
2017-10-01 | PHASE2; PHASE3 |
| NCT03376529 | COMPLETED | Healthy Volunteers |
Spero Therapeutics |
2017-11-10 | PHASE1 |
| NCT02822950 | COMPLETED | Pharmacokinetics of Avycaz in ICU Patients |
Michigan State University |
2017-01 | PHASE1 |
| NCT02497781 | COMPLETED | Complicated Urinary Tract Infections |
Pfizer |
2015-09-24 | PHASE2 |
| NCT02840136 | TERMINATED | Cystic Fibrosis |
University Ghent |
2016-02 | |
| NCT01667094 | UNKNOWN | Cystic Fibrosis |
The Alfred |
2012-09 | PHASE4 |
| NCT02526004 | COMPLETED | Cystic Fibrosis |
University College Cork |
2013-10-01 | |
| NCT02475733 | COMPLETED | Complicated Intra-abdominal Infections |
Pfizer |
2015-08-01 | PHASE2 |
| NCT01828892 | UNKNOWN | Low-output External Gastrointestinal Fistula |
Jinling Hospital, China |
2014-03 | |
| NCT02872038 | COMPLETED | Peritoneal Dialysis Associated Peritonitis |
Chulalongkorn University |
2015-08 | PHASE4 |
| NCT02504827 | COMPLETED | Cystic Fibrosis |
University of Southern California |
2015-09 | PHASE4 |
| NCT02732327 | TERMINATED | Neoplasms; Febrile Neutropenia |
Forest Laboratories |
2016-05-17 | PHASE2 |
| NCT02787057 | COMPLETED | Peritoneal Dialysis Associated Peritonitis |
Peking University First Hospital |
2012-11 | |
| NCT01808092 | COMPLETED | Nosocomial Pneumonia (NP); Ventilator-associated Pneumonia (VAP) |
Pfizer |
2013-04 | PHASE3 |
| NCT01507532 | WITHDRAWN | Renal Failure |
Midwestern University |
2012-01 | PHASE4 |
| NCT01726023 | COMPLETED | Complicated Intra-abdominal Infection |
Pfizer |
2013-01 | PHASE3 |
| NCT01893346 | COMPLETED | Systemic Infections |
Pfizer |
2013-07 | PHASE1 |
| NCT01344512 | COMPLETED | Pediatrics; Ceftazidime; Ciprofloxacin; Voriconazole |
University Hospital, Bordeaux |
2011-06 | |
| NCT01784445 | COMPLETED | Pancreatitis |
University Hospital Rijeka |
2013-06 | PHASE4 |
| NCT01644643 | COMPLETED | Complicated Urinary Tract Infection; Complicated Intra-abdominal Infection |
Pfizer |
2013-01 | PHASE3 |
| NCT01595438 | COMPLETED | Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis |
Pfizer |
2012-10 | PHASE3 |
| NCT01599806 | COMPLETED | Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis |
Pfizer |
2012-10 | PHASE3 |
| NCT01499290 | COMPLETED | Complicated Intra-Abdominal Infection |
Pfizer |
2012-03 | PHASE3 |
| NCT01455246 | TERMINATED | Cirrhosis; Ascites; Nosocomial Spontaneous Bacterial Peritonitis |
University of Padova |
2010-10 | PHASE2; PHASE3 |
| NCT01785641 | COMPLETED | Peritonitis |
Chulalongkorn University |
2012-12 | |
| NCT01920399 | COMPLETED | Healthy Volunteers |
Pfizer |
2013-10 | PHASE1 |
| NCT01430910 | COMPLETED | Healthy |
Pfizer |
2011-09 | PHASE1 |
| NCT01395420 | COMPLETED | Healthy |
Pfizer |
2011-08 | PHASE1 |
| NCT01534247 | COMPLETED | Healthy |
Pfizer |
2012-02 | PHASE1 |
| NCT01290900 | COMPLETED | Healthy Male Volunteers |
Pfizer |
2011-02 | PHASE1 |
| NCT01291602 | COMPLETED | Healthy Male and Female Japanese Volunteers |
Pfizer |
2011-02 | PHASE1 |
| NCT01044719 | UNKNOWN | Cystic Fibrosis |
Imperial College London |
2010-01 | PHASE4 |
| NCT00579956 | UNKNOWN | Melioidosis |
University of Oxford |
2007-12 | |
| NCT00690378 | COMPLETED | Complicated Urinary Tract Infection |
Pfizer |
2008-11 | PHASE2 |
| NCT00921024 | COMPLETED | Complicated Urinary Tract Infection |
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
2009-06-30 | PHASE2 |
| NCT00752219 | COMPLETED | Complicated Intra-abdominal Infections |
Pfizer |
2009-03-31 | PHASE2 |
| NCT00786305 | COMPLETED | Pneumonia |
Groupe Hospitalier Pitie-Salpetriere |
2004-10 | PHASE2 |
| NCT00823238 | COMPLETED | Cystic Fibrosis |
University of North Carolina, Chapel Hill |
2004-07 | PHASE1 |
| NCT02837835 | COMPLETED | Pneumonia |
CHU de Reims |
2005-03 | PHASE3 |
| NCT00210964 | COMPLETED | Pneumonia |
Basilea Pharmaceutica |
2005-04 | PHASE3 |
| NCT00229008 | COMPLETED | Pneumonia |
Basilea Pharmaceutica |
2005-11 | PHASE3 |
| NCT00210899 | COMPLETED | Skin Diseases, Infectious; Skin Diseases, Bacterial; Staphylococcal Skin Infections |
Basilea Pharmaceutica |
2005-09 | PHASE3 |
| NCT00333385 | TERMINATED | Cystic Fibrosis; Pseudomonas Aeruginosa; Pulmonary Exacerbation |
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche |
2001-10 | PHASE4 |
| NCT00173901 | UNKNOWN | Infection |
National Taiwan University Hospital |
2001-03 | PHASE4 |
| NCT00752882 | UNKNOWN | Pseudomonas Aeruginosa Meningitis |
University Hospital, Clermont-Ferrand |
PHASE2 | |
| NCT00153634 | COMPLETED | Cystic Fibrosis; Chronic Bronchitis |
Seattle Children's Hospital |
2004-03 | |
| NCT00360607 | COMPLETED | Infection |
Pfizer |
2004-07 | PHASE4 |
(data from https://clinicaltrials.gov, updated on 2026-08-12)
Mechanism and Biochemical Profile
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>).