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OpenTrials
Completed

NCT Number: NCT00035269

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

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

Completed

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Key information

Conditions

Pneumonia, Pneumococcal Bacterial Infections Bacterial Infections and Mycoses Community Acquired Infections Community-Acquired Infections Gram-Positive Bacterial Infections Infections Lung Diseases Pneumococcal Infections Pneumonia Pneumonia, Bacterial Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Center, Bratislava, Slovakia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antibiotic

Drug

Primary outcomes

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

  2. 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

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2003
First posted
May 3, 2002
Registry last updated
Apr 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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