NCT00771719

Brief Summary

The purpose of this research study is to measure the levels of ceftobiprole in the blood, urine and tissues of the lungs during and after administration of four doses of ceftobiprole. Safety of the drug will also be evaluated.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2008

Status
terminated

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

Study Start

First participant enrolled

October 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

1.1 years

First QC Date

October 9, 2008

Last Update Submit

July 27, 2012

Conditions

Ventilator Associated Pneumonia

Keywords

VAP

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine and tissues of the lungs) during dosing and 24 hours after last dose infused

    2 days

Secondary Outcomes (1)

  • Safety will be evaluated throughout the study.

    Study Duration

Study Arms (1)

Ceftobiprole

EXPERIMENTAL

Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days

Drug: Ceftobiprole

Interventions

CeftobiproleDRUG

Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days

Ceftobiprole

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed Consent
  • Between 18 and 75 years of age inclusive
  • VAP - 48 hours after onset of mechanical ventilation
  • BMI 18 - 35 inclusive
  • Albumin \< 3.3 g/dL or clinical evidence of edema
  • Negative Pregnancy test
  • Expected survival of at least 7 days

You may not qualify if:

  • Renal impairment (CrCl \< 80 mL/min)
  • Known drug allergy (including penicillin, cephalosporin, carbapenems, or other beta-lactams)
  • History of seizures
  • Sustained shock, unresponsive to sympathomimetics
  • Conditions that may have jeopardized adherence to the protocol (NYHA Class 4 cardiac disease, \>15% total body burn or significant third degree burn)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

ceftobiprole

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 13, 2008

Study Start

October 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

July 30, 2012

Record last verified: 2012-07