INEZOLID VS VANCOMYCIN IN THE TREATMENT OF COMPLICATED SKIN AND SOFT TISSUE INFECTIONS DUE TO PRESUMED OR PROVEN TO A GRAM POSITIVE GERM RESISTANT TO METICILLI

Not Applicable

• Conditions: -A499 Bacterial infection, unspecified; Bacterial infection, unspecified; A499

• Registration Number: PER-073-01
• Lead Sponsor: PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-11-22
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• The subjects must be at least 18 years of age.
• At the time of enrollment, patients are expected to survive effective antibiotic therapy and appropriate supportive care during treatment and follow-up.
• Patients should be willing to complete all activities related to the study.
• Patients who, after controlling for their acute infection, can be discharged for outpatient therapy.
• Patients who have specific signs and symptoms of an active infection, as indicated below for the following clinical syndromes.

Exclusion Criteria

• Patients with infected devices, when these are not removed.
• Hypersensitivity to linezolid, vancomycin or to one of the excipients in any drug formulation.
• Simultaneous use of another medication in research.
• Patient with osteomyelitis, endocarditis, meningitis or septic arthritis.
• Necrotizing fasciitis, caseose gangrene.
• Medical conditions in which the inflammation is prominent for a prolonged period, even after bacterial eradication, for example: superinfected eczema or atopic dermatitis.
• Patients with uncomplicated skin infections and superficial dermal structures such as superficial cellulitis, impetigo, boil, or simple abscess that only requires surgical drainage at the time of enrollment.
• Patients with self-limited infections such as isolated folliculitis in another infection that has a high cure rate with surgical incision or furunculosis or carbunculosis, not associated with cellulitis, of at least 1cm radius.
• Patients likely to require long-term hospitalization because of concomitant morbidities (for example: patients likely to require a prolonged stay in the hospital with ventilator use, etc.) Hospitalization due to an underlying comorbidity, where their treatment probably requires more time than the treatment of acute infection.
• It is proven that the acute infection is not due to a gram-positive bacterial pathogen, or only due to a gram-negative pathogen.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:In the EOT and TOC consultations, the researcher will evaluate the clinical effect of each patient according to the established criteria.<br>Measure:Clinical Effect<br>Timepoints:During the treatment<br>