None listed
Conditions
Interventions
Group 1 Type of group
600 mg of linezolid every 12 hours IV or PO
Group name:Group 2 Type of group
1 g Vancomycin every 12 hours IV (dose can be adjusted to maintain therapeutic levels). Patients with meticillin-sensitive germ cells (MSSA) will receive oxacillin sodium / Nafcillin / Fyucoxacillin (1 to 2 g every 6 hours, IV) or Dicloxacillin sodium (500 mg, every 6 hours, PO) after initial therapy with Vancomycin IV.
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:In the EOT and TOC consultations, the researcher will evaluate the clinical effect of each patient according to the established criteria. Measure:Clinical Effect Timepoints:During the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Comparisons between treatment groups will be established using chi-squared tests; only nominal p values will be reported. Measure:Discharge rates per week Timepoints:1 week ; Outcome name:The arithmetic mean will be calculated and the difference between treatments will be tested using the Students t test Measure:Duration of IV antibiotic treatment Timepoints:1 week ; Outcome name:The differences in the proportion of patients between the treatment groups that achieve the normalization of body temperature on days 1, 2, 3, 4, 7, as well as in the EOT and OCD consultations Measure:Body temperature Timepoints:Days 1, 2, 3, 4, 7 ; Outcome name:The significance of the mean changes from the reference frame to the follow-up in the size of the lesion within the treatment groups will be evaluated, using paired t-tests. Measure:Size of the lesion Timepoints:1 week ; Outcome name:The proportions of the patients in the corresponding categories of microbial effect between the treatment groups will be compared using an exact Fishers test for the homogeneity of the proportions. Measure:Microblological effect Timepoints:1 week | — |
Outcome results
None listed