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: October 20, 2014
Last verified: October 2014
  Purpose

This study will assess the efficacy and safety of intravenous beta-lactam, in co mparison with ceftriaxone, in hospitalized patients with community-acquired pneu monia 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 1427
Buenos Aires, Argentina, 1282
Buenos Aires, Argentina, 1888
Buenos Aires, Argentina, BUE1430
Buenos Aires, Argentina, 1657
Buenos Aires, Argentina, 1602
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, 1606
Sofia, Bulgaria, 1431
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, LV-1002
Riga, Latvia, 1038
Lithuania
Kaunas, Lithuania, 3000
Klaipeda, Lithuania, 92231
Vilnius, Lithuania, 08661
Peru
Lima, Peru, 31
Lima, Peru, 11
Lima, Peru, 1
Romania
Bucharest, Romania, 21659
Bucharest, Romania
Bucharest, Romania, 030303
Bucharest, Romania, 21105
Constanta, Romania, 8700
Craiova, Romania, 200515
Slovakia
Banska Bystrica, Slovakia, 975 17
Nitra, Slovakia, 950 01
Nitra, Slovakia, 949 88
Poprad, Slovakia, 058 87
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: October 20, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014