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

Roche

Status and phase: Completed; Phase 2

Conditions: Pneumonia, Bacterial

Treatments: Drug: Ceftriaxone; Drug: beta-lactam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00111644

WI18273

Details and patient eligibility

About

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.

Enrollment: 302 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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302 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: beta-lactam

Drug: beta-lactam

2

Experimental group

Treatment:

Drug: beta-lactam

Drug: beta-lactam

3

Active Comparator group

Treatment:

Drug: Ceftriaxone