Drugs / Ceftolozane/tazobactam
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02620774 | Feb 2016 → Apr 2017 | diabetes mellitus, skin infection | Hartford Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2019-07-29 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive EU CHMP Opinion for ZERBAXA® 3g Dose (ceftolozane and tazobactam) for the Treatment of Adults with Hospital-Acquired Pneumonia (HAP), Including Ventilator-Associated Pneumonia (VAP) merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending ZERBAXA® 3g dose (ceftolozane and tazobactam) for an additional indication for the treatment of hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), in adults. |
| 2019-06-03 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s ZERBAXA® (ceftolozane and tazobactam) 3g Dose for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) merck.com ↗ |
| 2015-04-27 | Merck Sharp & Dohme LLC | Results Merck Announces Publication of Pivotal Data from Phase 3 Clinical Studies of ZERBAXA™ (Ceftolozane/Tazobactam) in The Lancet and Clinical Infectious Diseases merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that The Lancet and Clinical Infectious Diseases have published online the results from the pivotal Phase 3 clinical studies of ZERBAXA™ (ceftolozane/tazobactam) for Injection (1 g/0.5 g) in complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI), respectively. |
All press releases naming this drug 3 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ceftolozane/tazobactam | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02620774 ↗ |
| Modality | Other / unclassified | “a novel β-lactam/β-lactamase combination antibiotic” NCT02620774 ↗ |
| Route | Intravenous | “3 or more doses of ceftolozane/tazobactam intravenously administered over 60 minutes every 8 hours” NCT02620774 ↗ |