Clinical trial NCT00035269: New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)
Official title: Linezolid in the Treatment of Penicillin-Resistant Streptococcus Pneumoniae Pneumonia: An Open-Label, Non-Comparator Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia, Pneumococcal
Community Acquired Infections
Gram-positive Bacterial Infections
Keywords: Pharmacia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-05-03
Enrollment: 230
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae)


Eligibility criteria: Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.

Inclusion Criteria:

* Patients must have the signs and symptoms of pneumonia, with a chest xray showing a pneumonia.
* The patient must have S. pneumoniae (a specific bacteria) growing in sputum or blood to continue treatment.

Exclusion Criteria:

* Patients cannot have taken more than one day of another antibiotic before entering this study.
* Patients with HIV and a low CD4 count are excluded.

Primary outcomes:
measure: To assess the microbiologic efficacy of linezolid in the treatment of patients with pneumonia caused by penicillin-resistant Streptococcus pneumoniae (PRSP).
measure: Additionally, microbiologic efficacy will be assessed in all pneumonia patients infected with S pneumoniae SP) and in those infected with penicillin-sensitive (PSSP) and penicillin-intermediate (PISP) S pneumoniae.
Secondary outcomes:
measure: To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Center
state: California
city: Jacksonville
country: United States
facility: Research Center
state: Florida
city: Naples
country: United States
facility: Research Center
state: Florida
city: Savannah
country: United States
facility: Research Center
state: Georgia
city: Springfield
country: United States
facility: Research Center
state: Illinois
city: Baton Rouge
country: United States
facility: Research Center
state: Louisiana
city: Baltimore
country: United States
facility: Research Center
state: Maryland
city: Ann Arbor
country: United States
facility: Research Center
state: Michigan
city: Royal Oak
country: United States
facility: Research Center
state: Michigan
city: Springfield
country: United States
facility: Research Center
state: Missouri
city: Hackensack
country: United States
facility: Research Center
state: New Jersey
city: Newark
country: United States
facility: Research Center
state: New Jersey
city: Somerville
country: United States
facility: Research Center
state: New Jersey
city: Staten Island
country: United States
facility: Research Center
state: New York
city: Stony Brook
country: United States
facility: Research Center
state: New York
city: Columbus
country: United States
facility: Research Center
state: Ohio
city: Zanesville
country: United States
facility: Research Center
state: Ohio
city: Fleetwood
country: United States
facility: Research Center
state: Pennsylvania
city: Hershey
country: United States
facility: Research Center
state: Pennsylvania
city: Ninety Six
country: United States
facility: Research Center
state: South Carolina
city: Spartanburg
country: United States
facility: Research Center
state: South Carolina
city: Harrogate
country: United States
facility: Research Center
state: Tennessee
city: Jackson
country: United States
facility: Research Center
state: Tennessee
city: Knoxville
country: United States
facility: Research Center
state: Tennessee
city: Memphis
country: United States
facility: Research Center
state: Tennessee
city: Memphis
country: United States
facility: Research Center
state: Tennessee
city: Memphis
country: United States
facility: Research Center
state: Tennessee
city: Nashville
country: United States
facility: Research Center
state: Tennessee
city: Dallas
country: United States
facility: Research Center
state: Texas
city: Houston
country: United States
facility: Research Center
state: Texas
city: Lubbock
country: United States
facility: Research Center
state: Texas
city: Charlottesville
country: United States
facility: Research Center
state: Virginia
city: Richmond
country: United States
facility: Research Center
state: Virginia
city: Seattle
country: United States
facility: Research Center
state: Washington
city: Bratislava
country: Slovakia
facility: Research Center
city: Mataro
country: Spain
facility: Research Center
state: Barcelona
city: Mostoles
country: Spain
facility: Research Center
state: Madrid
city: Barcelona
country: Spain
facility: Research Center
city: Barcelona
country: Spain
facility: Research Center
city: Barcelona
country: Spain
facility: Research Center
city: Girona
country: Spain
facility: Research Center
city: Madrid
country: Spain
facility: Research Center
city: Madrid
country: Spain
facility: Research Center
city: Madrid
country: Spain
facility: Research Center
city: Kaohsiung
country: Taiwan
facility: Research Center
city: Taoyuan
country: Taiwan
facility: Research Center
Study officials:
References: