Gram-positive Bacterial Infections Clinical Trial
Official title:
Linezolid in the Treatment of Penicillin-Resistant Streptococcus Pneumoniae Pneumonia: An Open-Label, Non-Comparator Study
| Verified date | April 2011 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae)
| Status | Completed |
| Enrollment | 230 |
| Est. completion date | May 2003 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 13 Years and older |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Slovakia | Research Center | Bratislava | |
| Spain | Research Center | Barcelona | |
| Spain | Research Center | Barcelona | |
| Spain | Research Center | Barcelona | |
| Spain | Research Center | Girona | |
| Spain | Research Center | Madrid | |
| Spain | Research Center | Madrid | |
| Spain | Research Center | Madrid | |
| Spain | Research Center | Mataro | Barcelona |
| Spain | Research Center | Mostoles | Madrid |
| Taiwan | Research Center | Kaohsiung | |
| Taiwan | Research Center | Taoyuan | |
| United States | Research Center | Ann Arbor | Michigan |
| United States | Research Center | Baltimore | Maryland |
| United States | Research Center | Baton Rouge | Louisiana |
| United States | Research Center | Charlottesville | Virginia |
| United States | Research Center | Columbus | Ohio |
| United States | Research Center | Dallas | Texas |
| United States | Research Center | Fleetwood | Pennsylvania |
| United States | Research Center | Hackensack | New Jersey |
| United States | Research Center | Harrogate | Tennessee |
| United States | Research Center | Hershey | Pennsylvania |
| United States | Research Center | Houston | Texas |
| United States | Research Center | Jackson | Tennessee |
| United States | Research Center | Jacksonville | Florida |
| United States | Research Center | Knoxville | Tennessee |
| United States | Research Center | Los Angeles | California |
| United States | Research Center | Lubbock | Texas |
| United States | Research Center | Memphis | Tennessee |
| United States | Research Center | Memphis | Tennessee |
| United States | Research Center | Memphis | Tennessee |
| United States | Research Center | Naples | Florida |
| United States | Research Center | Nashville | Tennessee |
| United States | Research Center | Newark | New Jersey |
| United States | Research Center | Ninety Six | South Carolina |
| United States | Research Center | Richmond | Virginia |
| United States | Research Center | Royal Oak | Michigan |
| United States | Research Center | Savannah | Georgia |
| United States | Research Center | Seattle | Washington |
| United States | Research Center | Somerville | New Jersey |
| United States | Research Center | Spartanburg | South Carolina |
| United States | Research Center | Springfield | Illinois |
| United States | Research Center | Springfield | Missouri |
| United States | Research Center | Staten Island | New York |
| United States | Research Center | Stony Brook | New York |
| United States | Research Center | Zanesville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Slovakia, Spain, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To assess the microbiologic efficacy of linezolid in the treatment of patients with pneumonia caused by penicillin-resistant Streptococcus pneumoniae (PRSP). | |||
| Primary | 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 | To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae. |
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