STUDY PHASE III, RANDOM, DOUBLE BLIND AND COMPARATIVE INTENDED TO EVALUATE THE EFFICACY AND SAFETY OF TIGECICLINE COMPARED TO LEVOFLOXACIN IN THE TREATMENT OF PATIENTS HOSPITALIZED WITH PNEUMONIA ACQUIRED IN THE COMMUNITY OF DATE APRIL 1, 2003

Not Applicable

• Conditions: -J159 Bacterial pneumonia, unspecified; Bacterial pneumonia, unspecified; J159

• Registration Number: PER-025-04
• Lead Sponsor: ABORATORIOS WYETH S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-05-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Female or male patients 18 years of age or older.
2. Patients hospitalized for an episode of pneumonia acquired in
the community that require IV antibiotic treatment.
3. Fever, defined as an oral temperature> 38 ° C, axillary> 38.1 ° C,
4. Chest x-ray (forehead and profile), within 48 hours prior to the administration of the first IV dose of the study drug, evidencing the presence of an infiltrate.

Exclusion Criteria

1. Any disease concomitant condition that, in the opinion of the investigator, could interfere in the evaluation of a response or hinder the course of the therapy so that it can not be completed.
2. Hospitalization within 14 days prior to the onset of symptoms.
3. Residence in a chronic disease care institution.
4. Score V in the Fine Scale for the determination of the severity index of pneumonia or order indication of hospitalization in the intensive care unit.
5. Hemodialysis, periloneal dialysis, plasmapheresis or concurrent hemoperfusion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified