Expired Study
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Ann Arbor, Michigan 48197


Purpose:

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


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.


Study is Available At:


Original ID:

M12600071


NCT ID:

NCT00035269


Secondary ID:

A5951056


Study Acronym:


Brief Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

13 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

230


Enrollment Type:

Actual


Study Dates

Start Date:December 2001
Completion Date:May 2003
Completion Type:Actual
Verification Date:April 2011
Last Changed Date:April 25, 2011
First Received Date:May 2, 2002

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.
Safety Issues:False
Outcome Type:Primary Outcome
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.
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To assess the microbiologic efficacy of linezolid in the treatment of patients with pneumonia caused by penicillin-resistant Streptococcus pneumoniae (PRSP).
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Antibiotic

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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