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: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

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

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

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

Lead Sponsor: Hoffmann-La Roche

Overall Clinical Trial Officials and Contacts

Clinical Trials Study Director Hoffmann-La Roche, +1 973 235 5000  

Information obtained from ClinicalTrials.gov on July 02, 2009

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