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Therapeutic Areas: Otolaryngology | Pulmonary/Respiratory Diseases | Immunology/Infectious Diseases
Disease Category: Pneumonia
Trial Information
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:
Interventional
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:
- 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: Males or Females
Age Limits: Min: 18 Years
Accepts Healthy Volunteers: No
Trial Registration Date: 07/26/2005
Date Last Updated: 05/19/2009
Link To Trial Results
E-mail: genentechclinicaltrials@druginfo.com
Research Site:
Located In:
Buenos Aires 1270
Argentina
Phone: 888-662-6728 (U.S. Only)
View Google Map
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