Drugs / Ceftolozane/tazobactam
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02070757 | Sep 2014 → May 2018 | lung disorder, nosocomial infection | Merck & Co., Inc. | Completed | Met primary |
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 ↗
The CHMP positive opinion will now be considered by the European Commission. |
| 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 ↗
Both studies met the pre-specified primary endpoints, and results of the secondary analyses for the studies were consistent with and supportive of the primary outcomes. |
All press releases naming this drug 3 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ceftolozane-tazobactam | “Ceftolozane-tazobactam versus meropenem for treatment of nosocomial pneumonia” PMID 31563344 ↗ Sep 2019 |
| Modality | Small molecule | “a novel antipseudomonal cephalosporin” NCT02070757 ↗ |
| Route | Intravenous | “Participants receive 3000 mg ceftolozane/tazobactam intravenous IV” NCT02070757 ↗ |