Clinical trial NCT00111644: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumonia, Bacterial
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2005-05-25
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Clinical cure rate\n\n
timeFrame: End of study visit (7-10 days after end of treatment)
Secondary outcomes:
measure: Adverse events, vital signs, laboratory parameters\n
timeFrame: Throughout study
Other outcomes:
Locations:
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Detroit
country: United States
state: Michigan
city: Butte
country: United States
state: Montana
city: Holmdel
country: United States
state: New Jersey
city: Winston-salem
country: United States
state: North Carolina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Ciudadela
country: Argentina
city: Córdoba
country: Argentina
city: Córdoba
country: Argentina
city: Granadero Baigorria
country: Argentina
city: Parana
country: Argentina
city: Rosario
country: Argentina
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Santiago
country: Chile
city: Valdivia
country: Chile
city: Zagreb
country: Croatia
city: Budapest
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Torokbalint
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Daugavpils
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Vilnius
country: Lithuania
city: Lima
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Constanta
country: Romania
city: Craiova
country: Romania
city: Banska Bystrica
country: Slovakia
city: Nitra
country: Slovakia
city: Nitra
country: Slovakia
city: Poprad
country: Slovakia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: