Trial Information

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

Status: Completed

Protocol Number: WI18273

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study of the effect of beta-lactam on treatment response in patients hospitalized with bacterial pneumonia

Brief Summary: 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. Target sample size is 300.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Pneumonia, Bacterial

Intervention Type: Drug

Intervention Name: Beta-Lactam

Primary Outcome: 1. Clinical cure rate Time frame: End of study visit (7-10 days after end of treatment)

Key Secondary Outcomes: 1. Adverse events, vital signs, laboratory parameters Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 07/26/2005

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:47:27 PM