A Study to Assess Beta-Lactam in the Treatment of Hospitalized Patients With Bacterial Pneumonia

Verified by: Hoffmann-La Roche, May 2009
First Received: May 24, 2005 | Last Updated: May 13, 2009 | Phase: Phase 2 | Start Date: 
Overall Status: Completed | Estimated Enrollment: 302
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This study will assess the efficacy and safety of intravenous beta-lactam, in comparison with ceftriaxone, in hospitalized patients with community-acquired pneumonia not caused by Legionella. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals...

Brief Summary

Official Title: “A Randomized, Double-Blind Study of the Effect of Beta-Lactam on Treatment Response in Patients Hospitalized With Bacterial Pneumonia”

This study will assess the efficacy and safety of intravenous beta-lactam, in comparison with ceftriaxone, in hospitalized patients with community-acquired pneumonia not caused by Legionella. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Drug: Beta-Lactam
    • 750mg iv q 23h for 3-14 days
  • Drug: Beta-Lactam
    • 1500mg iv q 12h for 3-14 days
  • Drug: Ceftriaxone
    • 1000mg iv daily

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
  • Experimental: 2
  • Active Comparator: 3

Outcome Measures for this Clinical Trial

Primary Measures

  • Clinical cure rate
    • Time Frame: End of study visit (7-10 days after end of treatment)
      Safety Issue?: No

Secondary Measures

  • Adverse events, vital signs, laboratory parameters
    • Time Frame: Throughout study
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • male or female patients at least 18 years of age;
  • hospitalization with community-acquired pneumonia or development of pneumonia within 48 hours of being hospitalized for another reason;
  • fever;
  • new or increased productive cough;
  • chest pain, shortness of breath, or rapid breathing.

Exclusion Criteria:

  • requiring intubation or ventilation;
  • nursing home or extended care within 60 days before study;
  • concomitant bacterial infection requiring antibiotics;
  • long-term immunosuppressive therapy.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Hoffmann-La Roche Industry

Overall Clinical Trial Officials and Contacts

Clinical Trials Study Director Hoffmann-La Roche  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00111644

Study ID Number: WI18273

ClinicalTrials.gov Identifier: NCT00111644

Health Authority: United States: Food and Drug Administration

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