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New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)

Linezolid in the Treatment of Penicillin-Resistant Streptococcus Pneumoniae Pneumonia: An Open-Label, Non-Comparator Study

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00035269
Enrollment
230
Registered
2002-05-03
Start date
2001-12-31
Completion date
2003-05-31
Last updated
2011-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community Acquired Infections, Gram-positive Bacterial Infections, Pneumonia, Pneumococcal

Keywords

Pharmacia

Brief summary

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

Interventions

DRUGAntibiotic

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frame
To assess the microbiologic efficacy of linezolid in the treatment of patients with pneumonia caused by penicillin-resistant Streptococcus pneumoniae (PRSP).
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

MeasureTime frame
To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.

Countries

Slovakia, Spain, Taiwan, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026