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 type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
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 Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 07/26/2005
Date last updated: 11/19/2009
Link to trial result
This trial was conducted at the following locations:
Argentina
- Buenos Aires
- Ciudadela
- Córdoba
- Granadero Baigorria
- Parana
- Rosario
Bulgaria
Chile
Croatia
Hungary
- Budapest
- Nyiregyhaza
- Torokbalint
- Zalaegerszeg
Latvia
Lithuania
Peru
Romania
- Bucharest
- Constanta
- Craiova
Slovakia
- Banska Bystrica
- Nitra
- Poprad
United States
- New Orleans, LA
- Shreveport, LA
- Detroit, MI
- Butte, MT
- Holmdel, NJ
- Winston-Salem, NC
