Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia

Conditions

Pneumonia

Keywords

Community-Acquired Pneumonia, Cephalosporins, Methicillin-Resistant Staphylococcus Aureus

Brief summary

The purpose of this study is to compare the clinical cure rate (ratio of clinically cured patients to the total number of patients) of ceftobiprole medocaril versus a comparator in the treatment of patients with community-acquired pneumonia.

Detailed description

Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole medocaril is not yet approved for the treatment of community-acquired pneumonia. This is a randomized, double-blind, multicenter study of ceftobiprole medocaril plus placebo versus a comparator to assess the effectiveness and safety of ceftobiprole medocaril in patients with community-acquired pneumonia. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. Patients who meet specified criteria may be switched to an alternative oral treatment. The primary endpoint is that the clinical cure rate among patients treated with ceftobiprole at the test of cure visit. The patients will receive either ceftobiprole medocaril plus placebo or a comparator.

Haihui Huang, Lei Gao, Marc Engelhardt, Mikael Saulay, Kamal Hamed

Future Microbiology2021-06-223 citations

10.2217/fmb-2021-0121

Efficacy and Safety of Ceftobiprole in Patients Aged 65 years or Older: a <i>Post Hoc</i> Analysis of Three Phase III studies

Tobias Welte, Thomas Scheeren, J. Scott Overcash, Mikael Saulay, Marc Engelhardt et al. (6 authors)

Future Microbiology2021-05-018 citations

10.2217/fmb-2021-0042

Early improvement in severely ill patients with pneumonia treated with ceftobiprole: a retrospective analysis of two major trials.

Scheeren TWL, Welte T, Saulay M, Engelhardt M, Santerre-Henriksen A, Hamed K.

2019-02-2617 citations

10.1186/s12879-019-3820-y

A randomised, double-blind trial comparing ceftobiprole medocaril with ceftriaxone with or without linezolid for the treatment of patients with community-acquired pneumonia requiring hospitalisation.

Nicholson SC, Welte T, File TM, Strauss RS, Michiels B, Kaul P, Balis D, Arbit D, Amsler K, Noel GJ.

2012-01-09106 citations

10.1016/j.ijantimicag.2011.11.005

Interventions

DRUGCeftobiprole medocaril

DRUGCeftriaxone with or without Linezolid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Patients suffering from community-acquired pneumonia severe enough to require hospitalization * Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control before entry and throughout the study

Exclusion criteria

* Patients with known or suspected hypersensitivity to any related antibiotic medications * Treatment with any experimental drug within 30 days before enrollment * Prior enrollment in this study or any study with ceftobiprole medocaril

Design outcomes

Primary

Measure	Time frame
Clinical cure rate (ratio of the number of clinically cured patients to the total number of patients) at the test of cure visit that occurs 7 to 14 days after the last dose of study drug	7 weeks

Secondary

Measure	Time frame
Microbiological eradication rate (ratio of the number of patients with microbiological eradication to the total number of patients)	7 weeks

Outcome results

None listed