NCT00326287

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
638

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2006

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

August 2, 2012

Status Verified

July 1, 2012

Enrollment Period

1.1 years

First QC Date

May 12, 2006

Last Update Submit

July 25, 2012

Conditions

Pneumonia

Keywords

Community-Acquired PneumoniaCephalosporinsMethicillin-Resistant Staphylococcus Aureus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Microbiological eradication rate (ratio of the number of patients with microbiological eradication to the total number of patients)

    7 weeks

Study Arms (2)

Ceftobiprole medocaril

EXPERIMENTAL

Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d

Drug: Ceftobiprole medocaril

Ceftriaxone with or without Linezolid

ACTIVE COMPARATOR

Ceftriaxone 2g qd as 0.5h infusions with or without Linezolid 600mg q12h as 1h infusions, 7-14d

Drug: Ceftriaxone with or without Linezolid

Interventions

Ceftobiprole medocarilDRUG
Ceftobiprole medocaril
Ceftriaxone with or without LinezolidDRUG
Ceftriaxone with or without Linezolid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 34155899DERIVED

  • 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.

    PMID: 33960817DERIVED

  • 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.

    PMID: 30808293DERIVED

  • Nicholson SC, Welte T, File TM Jr, Strauss RS, Michiels B, Kaul P, Balis D, Arbit D, Amsler K, Noel GJ. 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. Int J Antimicrob Agents. 2012 Mar;39(3):240-6. doi: 10.1016/j.ijantimicag.2011.11.005. Epub 2012 Jan 9.

    PMID: 22230331DERIVED

Related Links

MeSH Terms

Conditions

PneumoniaCommunity-Acquired Pneumonia

Interventions

ceftobiprole medocarilCeftriaxoneLinezolid

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesCommunity-Acquired Infections

Intervention Hierarchy (Ancestors)

CefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAcetamidesAcetatesAcids, AcyclicCarboxylic AcidsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 16, 2006

Study Start

June 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

August 2, 2012

Record last verified: 2012-07