MedTrace Logo

Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia

NCT00509106 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 622

Last updated 2017-03-14

Study results available
· View outcomes & findings →

Summary

The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.

Conditions

  • Bacterial Pneumonia

Interventions

DRUG

Ceftaroline fosamil for Injection

2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days

DRUG

Ceftriaxone

1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days

DRUG

Placebo

Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • IM Hoepelman, MD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-08-31
Completion
2009-06-30

Countries

  • United States
  • Argentina
  • Austria
  • Bulgaria
  • Chile
  • Germany
  • Hungary
  • India
  • Latvia
  • Mexico
  • Peru
  • Poland
  • Romania
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00509106 on ClinicalTrials.gov