8 completed. 3 Phase 2, 2 Phase 1, 2 Phase 3, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 3 | Completed 3 |
| Phase 1 | 2 | Completed 2 |
| Phase 3 | 2 | Completed 2 |
| Phase 4 | 1 | Completed 1 |
Follow ceftolozane: new trials by email Literature Review of ceftolozane trials Research Report on ceftolozane
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam Cefepime, Ceftolozane, Laboratory Biomarker Analysis - Other Infectious Diseases | Phase 2 | Completed | M.D. Anderson Cancer Center | 100 | 2018-05-16 | 2022-03-15 |
| Study of Ceftolozane/Tazobactam (MK-7625A) in Japanese Participants With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection (MK-7625A-014) MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) - Urinary Tract Infection (UTI), Complicated Urinary Tract Infection | Phase 3 | Completed | Merck Sharp & Dohme LLC | 115 | 2016-04-14 | 2019-02-05 |
| Study of Ceftolozane/Tazobactam (MK-7625A) in Combination With Metronidazole in Japanese Participants With Complicated Intra-abdominal Infection (MK-7625A-013) MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g), metronidazole 500 mg - Intra-abdominal Infection, Complicated Intra-abdominal Infection | Phase 3 | Completed | Merck Sharp & Dohme LLC | 100 | 2016-04-08 | 2018-08-09 |
| Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients Ceftolozane/Tazobactam - Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation | Phase 4 | Completed | Joseph L. Kuti, PharmD | 21 | 2015-09-01 | 2020-08-04 |
| Plasma Pharmacokinetics (PK) & Lung Penetration of Ceftolozane/Tazobactam in Participants With Pneumonia (MK-7625A-007) Ceftolozane/Tazobactam - Multiple Doses, Ceftolozane/Tazobactam - Single Dose - Critically Ill, Pneumonia | Phase 1 | Completed | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 37 | 2015-02-05 | 2019-08-28 |
| Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis (MK-7625A-010) Ceftolozane/Tazobactam 1000/500 mg, Ceftolozane/Tazobactam 30/15 mg/kg, Ceftolozane/Tazobactam 20/10 mg/kg - Proven or Suspected Gram-negative Bacterial Infection, Peri-operative Prophylaxis | Phase 1 | Completed | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 43 | 2014-09-17 | 2019-09-11 |
| Safety and Efficacy Study to Compare IV CXA 101/Tazobactam and Metronidazole With Meropenem in Complicated Intraabdominal Infections CXA-101/ tazobactam and metronidazole, meropenem plus saline placebo - Complicated Intra-abdominal Infection | Phase 2 | Completed | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 122 | 2010-06-25 | 2018-10-25 |
| Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections CXA-101, Ceftazidime - Complicated Urinary Tract Infection | Phase 2 | Completed | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 129 | 2009-06-30 | 2018-10-18 |
Pyelonephritis (2) · Critical Illness (1) · Cystic Fibrosis (1) · Intraabdominal Infections (1) · Pneumonia (1) · Pseudomonas Infections (1) · Urinary Tract Infections (1)
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (4) · Merck Sharp & Dohme LLC (2) · Joseph L. Kuti, PharmD (1) · M.D. Anderson Cancer Center (1)
United States (4) · Argentina (1) · Georgia (1) · Germany (1) · Poland (1) · Russia (1) · Serbia (1)
Ahmad Haidar, MD (1) · Florian Wagenlehner, MD (1) · Ian Friedland, MD (1) · Issam I Raad (1) · Joseph L Kuti, PharmD (1) · Ryszard Gellert, MD (1)
PMID 24982069, PMID 27550351, PMID 30153232, PMID 30528561, PMID 32211756, PMID 33567333, PMID 35663286, PMID 40913503
2014 (1)