A Study to Assess Beta-Lactam in the Treatment of Hospitalized Patients With Bacterial Pneumonia
- Registration Number
- NCT00111644
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 302
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 beta-lactam - 2 beta-lactam - 3 Ceftriaxone -
- Primary Outcome Measures
Name Time Method Clinical cure rate\n\n End of study visit (7-10 days after end of treatment)
- Secondary Outcome Measures
Name Time Method Adverse events, vital signs, laboratory parameters\n Throughout study