None listed
Conditions
Interventions
Group 1 Type of group
Linezolid: 600 mg every 12 hours intravenously and orally
Group name:Group 2 Type of group
Teicoplanin: intravenously or intramuscularly - dosage according to the package leaflet
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: • Male or female individuals must be at least 13 years old and weigh at least 40 kg. • At the time of incorporation into the study, patients are expected to survive the entire study, with effective antibiotic therapy and with appropriate care. • Patients should be willing to complete all activities related to the study. • Patients must have a known or suspected Gram positive infection, for which a treatment with a glycopeptide is clinically indicated.
Exclusion criteria
Exclusion criteria: • Female patients of childbearing age should not be breastfeeding, should have a negative baseline pregnancy test before taking any of the medications in the study, and practice proper pregnancy prevention methods to avoid becoming pregnant during pregnancy. study. Since linezolid is neither a substrate nor an inhibitor of human cytochrome P-450 enzymes, hormonal contraception is allowed, since no drug-drug interaction is expected. • Endocarditis of the left cavities, osteomyelitis and infections of the central nervous system. • Patients with infected devices that will not be removed. • Pheochromocytoma, carcinoid syndrome, untreated hyperthyroidism or uncontrolled hypertension, known. • Previous incorporation into this protocol or another linezolid protocol. • Hypersensitivity to linezolid, vancomycin, teicoplanin or one of the excipients of any of said drug formulations • Patients whose results from baseline laboratory tests are known to exceed the following criteria, will be ineligible for incorporation into the study: absolute neutrophil count 5, 0 x Upper Level Normal. • More than 24 hours of treatment with a potentially effective antibiotic within 48 hours prior to incorporation into the study, unless the therapy has failed. For more information on allowed treatments see Section 7.7 Prior and Concomitant Therapy. • Patients with infectious exacerbations of COPD. • Concomitant use of other medication under investigation. • Patients with anticipated infections require more than 28 days of treatment. • HIV positive patients who require P. carinii prophylaxis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:All patients will be evaluated for their clinical outcome at the end of treatment, short-term and long-term follow-up visits. Measure:clinical signs and symptoms, including vital signs, after treatment, compared to baseline, Timepoints:on days 3, 5 and 9 and when switching from IV therapy to oral therapy, during the treatment of the patient as an intern, and as an outpatient every 6 days according to the duration of the therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The patients microbiological responses will be evaluated and considered statistically according to the definitions detailed below. This type of evaluation is based mainly on the results obtained in the crops and on the sensitivity analyzes carried out in the central laboratory. • Documented microbiolodic eradication: The absence of the original pathogen or pathogens from the original site of infection on the day of the visit for the cure analysis. • Supposed microbiological eradication: The patient is clinically cured on the day of the visit of the healing analysis and there is no appropriate material to perform a culture of the original site of infection. Measure:Microbiological evaluations after treatment, compared to baseline, and when appropriate, Timepoints:on days 3, 5 and 9 and when switching from IV therapy to oral therapy, during the treatment of the patient as an intern, and as an outpatient every 6 days according to the duration of the therapy ; Outcome name:Through radiological evaluations carried out during the study. Measure:Radiological evaluations after treatment, compared to baseline. Timepoints:on days 3, 5 and 9 and when switching from IV therapy to oral therapy, during the treatment of the patient as an intern, and as an outpatient every 6 days according to the duration of the therapy | — |
Outcome results
None listed