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

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. Identifier: NCT00111644
Recruitment Status : Completed
First Posted : May 25, 2005
Last Update Posted : November 2, 2016
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

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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00111644

  Hide Study 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
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
Ruse, Bulgaria, 7002
Sofia, Bulgaria, 1233
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1606
Santiago, Chile
Valdivia, Chile
Zagreb, Croatia, 10000
Budapest, Hungary, 1529
Nyiregyhaza, Hungary, 4400
Torokbalint, Hungary, 2045
Zalaegerszeg, Hungary, 8900
Daugavpils, Latvia, 5417
Riga, Latvia, 1038
Riga, Latvia, LV-1002
Kaunas, Lithuania, 3000
Klaipeda, Lithuania, 92231
Vilnius, Lithuania, 08661
Lima, Peru, 11
Lima, Peru, 1
Lima, Peru, 31
Bucharest, Romania, 030303
Bucharest, Romania, 21105
Bucharest, Romania, 21659
Bucharest, Romania
Constanta, Romania, 8700
Craiova, Romania, 200515
Banska Bystrica, Slovakia, 975 17
Nitra, Slovakia, 949 88
Nitra, Slovakia, 950 01
Poprad, Slovakia, 058 87
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche 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, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents