drugset / Trial / NCT00229008
Ceftobiprole in Hospital Acquired Pneumonia
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the water-soluble prodrug \[form\] of ceftobiprole) referred to as ceftobiprole versus a comparator in the treatment of patients with nosocomial pneumonia.
Timeline
- Start
- 2005-11
- Primary completion
- 2007-05
- Completion
- 2007-05
Publications
- Hahn MM, Anderson MS, Snyder M, Du W, Chou Y-L, McCracken B, Smart JI, Litherland K, Keech S, von Siebenthal F, Jones M, Henning LN. Pharmacokinetic modeling and efficacy of ceftobiprole medocaril against pneumonic tularemia in cynomolgus macaques. Antimicrob Agents Chemother. 2025 Dec 10;69(12):e0127825. doi: 10.1128/aac.01278-25. Epub 2025 Nov 18.
- Huang H, Gao L, Engelhardt M, Saulay M, Hamed K. A post hoc analysis of two Phase III trials showing the efficacy and tolerability of ceftobiprole in East Asian patients. Future Microbiol. 2021 Jul;16:783-796. doi: 10.2217/fmb-2021-0121. Epub 2021 Jun 22.
- Welte T, Scheeren TW, Overcash JS, Saulay M, Engelhardt M, Hamed K. Efficacy and safety of ceftobiprole in patients aged 65 years or older: a post hoc analysis of three Phase III studies. Future Microbiol. 2021 May;16:543-555. doi: 10.2217/fmb-2021-0042. Epub 2021 May 7.
- Scheeren TWL, Welte T, Saulay M, Engelhardt M, Santerre-Henriksen A, Hamed K. Early improvement in severely ill patients with pneumonia treated with ceftobiprole: a retrospective analysis of two major trials. BMC Infect Dis. 2019 Feb 26;19(1):195. doi: 10.1186/s12879-019-3820-y.
- Awad SS, Rodriguez AH, Chuang YC, Marjanek Z, Pareigis AJ, Reis G, Scheeren TW, Sanchez AS, Zhou X, Saulay M, Engelhardt M. A phase 3 randomized double-blind comparison of ceftobiprole medocaril versus ceftazidime plus linezolid for the treatment of hospital-acquired pneumonia. Clin Infect Dis. 2014 Jul 1;59(1):51-61. doi: 10.1093/cid/ciu219. Epub 2014 Apr 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ceftazidime | Small molecule | 2 g | Intravenous |
| Subject | Ceftobiprole | Small molecule | 500 mg | Intravenous |
| Comparator | Linezolid | Other / unclassified | 600 mg | Intravenous |