Drugs / Ceftazidime
Ceftazidime
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed urinary tract infection 1 milestone | |||||
| Filed | US (FDA) | AVYCAZ | urinary tract infection | 2018-11-20 | “has accepted for review the company's supplemental New Drug Application (sNDA) for AVYCAZ® (ceftazidime and avibactam)” abbvie.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Zavicefta | — | 2016-06-23 | europa.eu ↗ |
| Approved | US (FDA) | FORTAZ | — | 1985-07-19 | fda.gov ↗ |
Trials 41
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials · 1 met primary | ||||||
| Phase 1 | NCT03376529 | Nov → Dec 2017 | — | Spero Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01920399 | Oct → Nov 2013 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01789528 | Aug 2013 → Mar 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01893346 | Jul 2013 → Oct 2014 | infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01534247 | Feb → Jul 2012 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01395420 | Aug 2011 → Jul 2012 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01290900 | Feb → May 2011 | — | Pfizer | Completed | Met primary |
| Phase 28 trials | ||||||
| Phase 2 | NCT07842198 | Mar 2027 → Dec 2029 expected | large B-cell lymphoma, plasma cell myeloma | Zealand University Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06406114 | May 2025 → Jul 2028 expected | anaphylaxis, drug allergy, drug pseudoallergy | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04126031 | Jan 2020 → Dec 2022 | gram-negative bacterial infections | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT02497781 | Sep 2015 → Sep 2017 | urinary tract infection | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01601093 | Nov 2011 → Aug 2022 | respiratory tract infectious disorder, urinary tract infection | Xiangbei Welman Pharmaceutical Co., Ltd | Suspended | No outcome recorded |
| Phase 2 | NCT00752219 | Mar → Nov 2009 | — | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00690378 | Nov 2008 → Jun 2010 | bacterial urinary tract infection | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00752882 | ? → Jun 2009 | bacterial meningitis caused by gram-negative bacteria | University Hospital, Clermont-Ferrand | Unknown | No outcome recorded |
| Phase 38 trials · 5 met primary | ||||||
| Phase 3 | NCT04927312 | Oct 2021 → Sep 2022 | — | Pfizer | Completed | Met primary |
| Phase 3 | NCT01808092 | Apr 2013 → Jan 2016 | — | Pfizer | Completed | Met primary |
| Phase 3 | NCT01726023 | Jan 2013 → Mar 2015 | — | Pfizer | Completed | Met primary |
| Phase 3 | NCT01644643 | Jan 2013 → Sep 2014 | urinary tract infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01599806 | Oct 2012 → Aug 2014 | acute pyelonephritis | Pfizer | Completed | Met primary |
| Phase 3 | NCT01595438 | Oct 2012 → Aug 2014 | acute pyelonephritis | Pfizer | Completed | Met primary |
| Phase 3 | NCT01499290 | Mar 2012 → Apr 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02837835 | Mar 2005 → Feb 2008 | pneumonia | Reims University Hospital | Completed | No outcome recorded |
| Phase 412 trials · 1 met primary | ||||||
| Phase 4 | NCT07311343 | Jan → Dec 2026 expected | hemorrhagic disease, pneumonia | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07016165 | Jun → Nov 2025 overdue | acute lymphoblastic leukemia, acute myeloid leukemia, neutropenia | Gadjah Mada University | Recruiting | No outcome recorded |
| Phase 4 | NCT06811727 | May 2025 → May 2027 expected | primary bacterial infectious disease | Ivan Šitum, MD | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06766461 | Jan 2025 → Dec 2026 expected | infectious disease with sepsis | Erasmus Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT04948463 | Nov 2021 → Dec 2025 | neutropenia | Murdoch Childrens Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT04882085 | Aug 2021 → Aug 2023 | acute pyelonephritis, bacterial pneumonia, infectious peritonitis | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT04774094 | May 2021 → May 2023 | nosocomial infection | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT02593201 | Feb 2016 → Dec 2018 | — | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 4 | NCT01784445 | Jun 2013 → Sep 2014 | pancreatitis | University Hospital Rijeka | Completed | No outcome recorded |
| Phase 4 | NCT00360607 | Jul 2004 → Apr 2005 | infectious disease | Pfizer | Completed | Met primary |
| Phase 4 | NCT00333385 | Oct 2001 → Apr 2004 | Pseudomonas aeruginosa infectious disease, cystic fibrosis, lung disorder | Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche | Terminated | No outcome recorded |
| Phase 4 | NCT00173901 | Mar 2001 → Apr 2002 | infectious disease | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT07085624 | Oct → Nov 2026 expected | Pseudomonas aeruginosa infectious disease, infectious disease with sepsis, primary bacterial infectious disease | University Hospital of Saint-Etienne | Not yet recruiting | No outcome recorded |
| — | NCT02840136 | Feb 2016 → Sep 2017 | cystic fibrosis | University Ghent | Terminated | No outcome recorded |
| — | NCT01785641 | Dec 2012 → Dec 2013 | peritonitis | Chulalongkorn University | Completed | No outcome recorded |
| — | NCT02787057 | Nov 2012 → Apr 2016 | infectious peritonitis | Peking University First Hospital | Completed | No outcome recorded |
| — | NCT01344512 | Jun 2011 → Sep 2014 | — | University Hospital, Bordeaux | Completed | No outcome recorded |
| — | NCT00153634 | Mar 2004 → Nov 2007 | chronic bronchitis, cystic fibrosis | Seattle Children's Hospital | Completed | No outcome recorded |
| Comparator or background therapy33 trials | ||||||
| Phase 0 | NCT06967376 Comparator | May 2018 → Nov 2021 | keratitis | Research Institute of Ophthalmology, Egypt | Completed | No outcome recorded |
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01430910 Comparator | Sep 2011 → Oct 2012 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01291602 Background | Feb → Apr 2011 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00823238 Comparator | Jul 2004 → May 2008 | cystic fibrosis | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 2 | NCT07840105 Comparator | Sep 2026 → Sep 2027 expected | acute pyelonephritis | Wockhardt | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07318584 Comparator | Mar 2026 → Feb 2028 expected | escherichia coli discitis | Oregon Health and Science University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06368804 Comparator | Sep 2024 → Mar 2025 overdue | bronchiectasis | Centre Hospitalier Intercommunal Creteil | Recruiting | No outcome recorded |
| Phase 2 | NCT05105035 Background | Jun 2022 → Oct 2023 | melioidosis | Arrevus Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00921024 Comparator | Jun 2009 → Feb 2010 | urinary tract infection | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00786305 Comparator | Oct 2004 → Sep 2008 | pneumonia caused by pseudomonas aeruginosa infection | Groupe Hospitalier Pitie-Salpetriere | Completed | No outcome recorded |
| Phase 2/3 | NCT04879030 Background | Jan → Aug 2020 | chronic obstructive pulmonary disease | Haiphong University of Medicine and Pharmacy | Completed | No outcome recorded |
| Phase 2/3 | NCT03404739 Comparator | Oct 2017 → Dec 2018 | achalasia | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT01455246 Comparator | Oct 2010 → Apr 2014 | cirrhosis of liver | University of Padova | Terminated | No outcome recorded |
| Phase 3 | NCT07327619 Comparator | Jan 2026 → Jun 2028 expected | bacterial pneumonia | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07063095 Background | Aug 2025 → Dec 2026 expected | gram-negative bacterial infections, infectious disease with sepsis | Angela HUTTNER | Recruiting | No outcome recorded |
| Phase 3 | NCT03439124 Comparator | Nov 2017 → Mar 2020 | bacterial pneumonia | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 3 | NCT02795949 Comparator | Oct 2016 → Jan 2020 | bacterial infectious disease | Andalusian Public Foundation for Health Research in Seville | Completed | Met primary |
| Phase 3 | NCT00229008 Comparator | Nov 2005 → May 2007 | pneumonia | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 3 | NCT00210899 Comparator | Sep 2005 → Oct 2006 | skin disease caused by bacterial infection, staphylococcal infection | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 3 | NCT00210964 Comparator | Apr 2005 → May 2007 | pneumonia | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 4 | NCT07590648 Background | Jun 2026 → Jul 2028 expected | bacterial infectious disease, childhood malignant neoplasm, hematopoietic and lymphoid cell neoplasm, neutropenia | Hospital Universitari Vall d'Hebron Research Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05977868 Comparator | Aug 2023 → Feb 2025 | digestive system infectious disorder | West Virginia University | Terminated | No outcome recorded |
| Phase 4 | NCT05971537 Comparator | Jun 2023 → Oct 2026 expected | infectious peritonitis | Alice Ho Miu Ling Nethersole Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04187755 Comparator | Mar → Jul 2019 | childhood malignant neoplasm, leukemia, neutropenia | Indonesia University | Completed | No outcome recorded |
| Phase 4 | NCT02894684 Background | Jan 2017 → Feb 2019 | Pseudomonas infection, cystic fibrosis | Liverpool Heart and Chest Hospital NHS Foundation Trust | Completed | Met primary |
| Phase 4 | NCT02872038 Comparator | Aug 2015 → Nov 2016 | infectious peritonitis | Chulalongkorn University | Completed | Met primary |
| Phase 4 | NCT01667094 Comparator | Sep 2012 → Jul 2017 | cystic fibrosis | The Alfred | Unknown | No outcome recorded |
| Phase 4 | NCT01044719 Comparator | Jan → Oct 2010 | cystic fibrosis | Imperial College London | Unknown | No outcome recorded |
| — | NCT03754387 Comparator | Jan 2019 → Jan 2021 | appendicitis | Zunyi Medical College | Unknown | No outcome recorded |
| — | NCT01828892 Background | Mar 2014 → Jun 2017 | intestinal fistula | Jinling Hospital, China | Unknown | No outcome recorded |
| — | NCT02526004 Background | Oct 2013 → Jun 2017 | cystic fibrosis | University College Cork | Completed | No outcome recorded |
| — | NCT00579956 Comparator | Dec 2007 → Sep 2010 | melioidosis | University of Oxford | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2019-03-18 | AbbVie | Regulatory Allergan Announces FDA Approval of AVYCAZ® (ceftazidime and avibactam) for Pediatric Patients abbvie.com ↗
This is the first FDA approval of a pediatric indication for cUTI and cIAI in more than a decade. |
| 2018-11-20 | AbbVie | Regulatory Allergan Announces FDA Acceptance of Supplemental New Drug Application for AVYCAZ® (ceftazidime and avibactam) abbvie.com ↗ |
| 2018-02-01 | AbbVie | Regulatory FDA Approves AVYCAZ® (ceftazidime and avibactam) for the Treatment of Patients with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia abbvie.com ↗ |
| 2017-04-24 | Pfizer | Results Pivotal Phase III Study Underscores Efficacy Of Zavicefta™ (ceftazidime-avibactam) For Treatment Of Hospital-Acquired Pneumonia, A Leading Cause Of Mortality In Hospitals pfizer.com ↗
In addition, patients treated with Zavicefta and Meropenem experienced comparable rates of tolerability consistent with the known profile of ceftazidime alone. |
All press releases naming this drug 4 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 74 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ceftazidime | “Beta lactam antibiotics for non-ESBL E. coli infections include preferred ceftriaxone or alternative cephalosporins (cefepime, ceftazidime), penicillins...” NCT07318584 ↗73“The beta-lactam antibiotics with activity against gram-negative bacilli in this study included piperacillin-tazobactam, ticarcillin-clavulanate, imipenem-cilastin, meropenem,...” NCT04879030 ↗ “Some commonly used antibiotics for the treatment of PD peritonitis with their suggested concentrations in the antibiotic-lock are quoted as below: Cefazolin 10mg/mL...” NCT05971537 ↗ “Initial antimicrobial therapy for both groups consisted of fortified vancomycin eye drops 50 mg/ml, fortified ceftazidime eye drops 50 mg/ml hourly, and the antifungal agent...” NCT06967376 ↗ “Patients received a single 2-h intravenous infusion of ceftazidime-avibactam (cohort 1, 2,000 to 500 mg; cohort 2, 2,000 to 500 mg [≥40 kg] or 50 to 12.5 mg/kg [<40 kg];...” PMID 27503642 ↗ Sep 2016 “Drug stop within 24 hours after randomization:Piperacillin-tazobactam, amikacin, meropenem, cefepime, ceftazidime, vancomycin, teicoplanin, ciprofloxacin, levofloxacine and...” NCT07590648 ↗ “Ceftazidime-avibactam combines the established anti-pseudomonal cephalosporin, ceftazidime, with the novel non-β-lactam β-lactamase inhibitor, avibactam.” PMID 32602065 ↗ Aug 2020 “Ceftazidime-Avibactam powder for concentrate for solution for infusion 2.0 g/ 0.5 g. Dosage will be adjusted based on renal function after enrollment.” NCT04927312 ↗ “standard to double dosing of beta-lactam antibiotics (cefuroxime, ceftazidime, ceftriaxone, cefotaxime, amoxicillin, amoxicillin/clavulanic acid,” PMID 40119275 ↗ Mar 2025 “immediate intensive oral hygiene treatment (chlorhexidine 20 ml, three times a day) combined with antibiotics (ceftazidime 1 g, every 8 hours)” NCT07311343 ↗ “Cohort 1: CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) by intravenous infusion given over 2 hours, every 8 hours” NCT01789528 ↗ |
| Known as | Ceftazidime sodium | “Intravenous Ceftazidime sodium (50mg/kg/dose every 12 hours) was administered for 3 days.” NCT03754387 ↗ |
| Known as | Fortam | “Ceftazidime (Fortam®), or ceftazidime-avibactam (Zavicefta®), is a standard antibiotic commonly used for this purpose” NCT07063095 ↗ |
| Known as | Fortum | “Fortum (Ceftazidime for injection USP) Glaxo Smith Kline Pharmaceuticals Limited” NCT00360607 ↗ |
| Modality | Small molecule | “Ceftazidime is a third generation cephalosporins” NCT00173901 ↗ |
| Route | Intravenous | “ceftazidime 2 g every 8 hours as a 120-minute intravenous infusion” NCT00210964 ↗ |