Back to resultsA Study to Assess Beta-Lactam in the Treatment of Hospitalized Patients With Bacterial Pneumonia
Primary Purpose
Pneumonia, Bacterial
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ceftriaxone
beta-lactam
beta-lactam
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia, Bacterial
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Clinical cure rate\n\n
Secondary Outcome Measures
Adverse events, vital signs, laboratory parameters\n
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00111644
Brief Title
A Study to Assess Beta-Lactam in the Treatment of Hospitalized Patients With Bacterial Pneumonia
Official Title
A Randomized, Double-blind Study of the Effect of Beta-lactam on Treatment Response in Patients Hospitalized With Bacterial Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Bacterial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
302 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone
Intervention Description
1000mg iv daily
Intervention Type
Drug
Intervention Name(s)
beta-lactam
Intervention Description
750mg iv q 23h for 3-14 days
Intervention Type
Drug
Intervention Name(s)
beta-lactam
Intervention Description
1500mg iv q 12h for 3-14 days
Primary Outcome Measure Information:
Title
Clinical cure rate\n\n
Time Frame
End of study visit (7-10 days after end of treatment)
Secondary Outcome Measure Information:
Title
Adverse events, vital signs, laboratory parameters\n
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
City
Holmdel
State/Province
New Jersey
ZIP/Postal Code
07733
Country
United States
City
Winston-salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Buenos Aires
ZIP/Postal Code
1180
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
1282
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
1427
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
1602
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
1657
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
1888
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
BUE1430
Country
Argentina
City
Ciudadela
ZIP/Postal Code
1702
Country
Argentina
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
City
Córdoba
ZIP/Postal Code
X5004CDT
Country
Argentina
City
Granadero Baigorria
ZIP/Postal Code
2152
Country
Argentina
City
Parana
ZIP/Postal Code
3100
Country
Argentina
City
Rosario
ZIP/Postal Code
S2000DSV
Country
Argentina
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
City
Santiago
Country
Chile
City
Valdivia
Country
Chile
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
City
Daugavpils
ZIP/Postal Code
5417
Country
Latvia
City
Riga
ZIP/Postal Code
1038
Country
Latvia
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
City
Kaunas
ZIP/Postal Code
3000
Country
Lithuania
City
Klaipeda
ZIP/Postal Code
92231
Country
Lithuania
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
City
Lima
ZIP/Postal Code
11
Country
Peru
City
Lima
ZIP/Postal Code
1
Country
Peru
City
Lima
ZIP/Postal Code
31
Country
Peru
City
Bucharest
ZIP/Postal Code
030303
Country
Romania
City
Bucharest
ZIP/Postal Code
21105
Country
Romania
City
Bucharest
ZIP/Postal Code
21659
Country
Romania
City
Bucharest
Country
Romania
City
Constanta
ZIP/Postal Code
8700
Country
Romania
City
Craiova
ZIP/Postal Code
200515
Country
Romania
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
City
Nitra
ZIP/Postal Code
949 88
Country
Slovakia
City
Nitra
ZIP/Postal Code
950 01
Country
Slovakia
City
Poprad
ZIP/Postal Code
058 87
Country
Slovakia
12. IPD Sharing Statement
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A Study to Assess Beta-Lactam in the Treatment of Hospitalized Patients With Bacterial Pneumonia
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