drugset / Trial / NCT03137173
Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This was a randomized, double-blind, active-controlled, parallel-group, multicenter study in adult hospitalized patients to establish the safety and efficacy of ceftobiprole medocaril compared with vancomycin plus aztreonam in the treatment of acute bacterial skin and skin structure infections (ABSSSIs).
Timeline
- Start
- 2018-02-19
- Primary completion
- 2019-04-22
- Completion
- 2019-04-22
Publications
- 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.
- Overcash JS, Kim C, Keech R, Gumenchuk I, Ninov B, Gonzalez-Rojas Y, Waters M, Simeonov S, Engelhardt M, Saulay M, Ionescu D, Smart JI, Jones ME, Hamed KA. Ceftobiprole Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Results of a Phase 3, Randomized, Double-blind Trial (TARGET). Clin Infect Dis. 2021 Oct 5;73(7):e1507-e1517. doi: 10.1093/cid/ciaa974.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aztreonam | Small molecule | 1000 mg | Intravenous |
| Subject | Ceftobiprole medocaril | Small molecule | 500 mg | Intravenous |
| Comparator | Vancomycin | Other / unclassified | 15 mg/kg | Intravenous |
| Comparator | Vancomycin | Other / unclassified | 1000 mg | Intravenous |
Indications
No indication recorded.