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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00111644
First received: May 24, 2005
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Pneumonia, Bacterial
Drug: beta-lactam
Drug: Ceftriaxone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study of the Effect of Beta-lactam on Treatment Response in Patients Hospitalized With Bacterial Pneumonia

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Clinical cure rate\n\n [ Time Frame: End of study visit (7-10 days after end of treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events, vital signs, laboratory parameters\n [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 302
Study Start Date: March 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: beta-lactam
750mg iv q 23h for 3-14 days
Experimental: 2 Drug: beta-lactam
1500mg iv q 12h for 3-14 days
Active Comparator: 3 Drug: Ceftriaxone
1000mg iv daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111644

  Show 49 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00111644     History of Changes
Other Study ID Numbers: WI18273
Study First Received: May 24, 2005
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pneumonia, Bacterial
Pneumonia
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ceftriaxone
Lactams
Beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014