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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00111644
First Posted: May 25, 2005
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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: Ceftriaxone Drug: beta-lactam Phase 2

Study Type: Interventional
Study Design: 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

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) ]

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

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

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.
  Contacts and Locations
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


  Hide Study Locations
Locations
United States, Louisiana
New Orleans, Louisiana, United States, 70112
Shreveport, Louisiana, United States, 71105
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Montana
Butte, Montana, United States, 59701
United States, New Jersey
Holmdel, New Jersey, United States, 07733
United States, North Carolina
Winston-salem, North Carolina, United States, 27103
Argentina
Buenos Aires, Argentina, 1180
Buenos Aires, Argentina, 1282
Buenos Aires, Argentina, 1427
Buenos Aires, Argentina, 1602
Buenos Aires, Argentina, 1657
Buenos Aires, Argentina, 1888
Buenos Aires, Argentina, BUE1430
Ciudadela, Argentina, 1702
Córdoba, Argentina, 5000
Córdoba, Argentina, X5004CDT
Granadero Baigorria, Argentina, 2152
Parana, Argentina, 3100
Rosario, Argentina, S2000DSV
Bulgaria
Ruse, Bulgaria, 7002
Sofia, Bulgaria, 1233
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1606
Chile
Santiago, Chile
Valdivia, Chile
Croatia
Zagreb, Croatia, 10000
Hungary
Budapest, Hungary, 1529
Nyiregyhaza, Hungary, 4400
Torokbalint, Hungary, 2045
Zalaegerszeg, Hungary, 8900
Latvia
Daugavpils, Latvia, 5417
Riga, Latvia, 1038
Riga, Latvia, LV-1002
Lithuania
Kaunas, Lithuania, 3000
Klaipeda, Lithuania, 92231
Vilnius, Lithuania, 08661
Peru
Lima, Peru, 11
Lima, Peru, 1
Lima, Peru, 31
Romania
Bucharest, Romania, 030303
Bucharest, Romania, 21105
Bucharest, Romania, 21659
Bucharest, Romania
Constanta, Romania, 8700
Craiova, Romania, 200515
Slovakia
Banska Bystrica, Slovakia, 975 17
Nitra, Slovakia, 949 88
Nitra, Slovakia, 950 01
Poprad, Slovakia, 058 87
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00111644     History of Changes
Other Study ID Numbers: WI18273
First Submitted: May 24, 2005
First Posted: May 25, 2005
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