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

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ClinicalTrials.gov Identifier: NCT00111644
Recruitment Status : Completed
First Posted : May 25, 2005
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pneumonia, Bacterial Drug: Ceftriaxone Drug: beta-lactam Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Clinical cure rate\n\n [ Time Frame: End of study visit (7-10 days after end of treatment) ]

Secondary Outcome Measures :
  1. Adverse events, vital signs, laboratory parameters\n [ Time Frame: Throughout study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111644


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00111644     History of Changes
Other Study ID Numbers: WI18273
First Posted: May 25, 2005    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Ceftriaxone
Lactams
beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents