None listed
Conditions
Interventions
Linezolid intravenous: 600 mg every 12 hours
Linezolid oral: 600 mg every 12 hours
For 10 to 21 consecutive days
Group name:CONTROL Type of group
Oxacilin Sodium intravenous: 2 gm every 6 hours
Dicloxacillin Sodium oral: 500 mg every 6 hours
For 10 to 21 consecutive days
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: 1. A suspected gram-positive complicated skin and soft tissue infection caused by susceptible organisms that involves deeper soft tissue, may require significant surgical intervention (such as a major abscess, infected ulcer, major bum, or deep and extensivo cellulitis -please see Expanded Definitions in Appendix A), and with at least two of the following: > drainage/discharge > erythema > fluctuance > heat/localized warmth > pain/tendemess to palpation > swelling/induration 2. An accessible infection site for Gram stain and culture. 3. At least one of the following conditions considered to be pathogen related: > fever, defined as body temperatura >37.5°C/99.5°F (axillary); >38°C/100.4°F (orally); >38.5°C/I01.3°F (tympanically); or>39°C/102.2°F (rectally). > elevated total peripheral white blood cell count >10,000/mm^. > >15% immature neutrophils (bands) regardless of total peripheral white count. 4. Be at least 18 years of age. 5. Able to take intravenous and oral medications. 6. Willing to retum for the End-of-Treatment and Long Term Follow-up visits
Exclusion criteria
Exclusion criteria: The presence of anv of the following conditions will exelude a patient irom study eligibility. 1. Previous antibiotic treatment received for more than 24 hours within 7 days of study entry unless the pathogen showed drug resistance or the treatment failed (defined as no clinical improvement after 3 days of treatment). 2. An uncomplicated skin and superficial skin structure infection such as a simple abscess, impetiginous lesion, fiiruncle, or superficial cellulitis. 3. Abscesses that only need surgical draining at the time of patient enrollment. 4. Self limited infections such as isolated folliculitis or other infection that has a high surgical incision cure rate or furunculosis or carbunculosis that is not associated with a cellulitis at least 1 cm in radius. 5. Diabetic foot, decubitus, and ischemic ulcers, necrotizing fasciitis, gas gangrene, or bums greater than 20% of total body surface. 6. Superinfected eczema or other chronic medical conditions (ie, atopic dermatitis) where inflammation may be prominent for an extended period even after successful bacterial eradication. 7. Infections or conditions requiring concomitant antimicrobial (with the exception of aztreonam; please see Seciion 7.2) or systemic corticosteroid treatment. 8. Infections complicated by the presence of prosthetic matariais such central venous catheters, permanent cardiac pacemaker battery packs, or those involving joint replacement prostheses, etc. 9. Known osteomyelitis. 10. Pernales of child-bearing potential who are unable to take adequate contraceptiva precautions, have a positiva serum pregnancy test result within 24 hours prior to study entry, are otherwise known to be pregnant, or are currently breastfeeding an infant. 11. Known liver disease with total bilirubin >5 times Upper Limit of Normal. 12. Known neutropenia (absoluta neutrophil count <500 cells/mm^). 13. Pheochromocytoma, carcinoid syndrome, or uncontrolled hypertension. 14. Untreated hyperthyroidism. 15. Unlikely to survive through the treatment period and evaluation (< 60 days). 16. Hypersensitivity to linezolid or its formulation excipients {please see Seciion 7). 17. Hypersensitivity to penicillins or their formulation excipients (seeAppendix C). 18. Another investigational medication received within the past 30 days. 19. Previous enrollment in this or another linezolid protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:• Cured. Resolution of infection signs and symptoms or improvement to such an extent that no further antimicrobial treatment is necessary. • Tmproved. Partial resolution of clinical symptoms with no additional antimicrobial therapy required (this outcome category will only be used at the End-of-Treatment evaluation). • Failed. Persistence, incomplete resolution, or worsening of entry signs and symptoms with emergence of new disease signs or symptoms and/or requiring additional antimicrobial therapy. Patients experiencing adverse event(s) that requires study medication discontinuation will be deemed clinical failures. • Indeterminate. Extenuating circumstances that preclude classification to one of the above outcomes. Measure:Efficacy Outcomes (clinical and microbiological) Timepoints:At the end-of-Treatment, and at a final visit after treatment (Long Term Follow-up). | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:• Documented microbiologic eradication. The absence of the original pathogen or pathogens from the culture of the original site of infection at the test-of-cure visit. • Prcaumcd microbiologic eradication. Tlic patient is cllilically cuied aL llie lesl-of-cure visit and no appropriate material is available for culture from the original site of infection • documented microbiologic persistence. The presence of at least one of tiie original pathogens from the culture of the original site of infection at the test-of-cure visit. • Presumed microbiologic persistence. The patient is a clinical failure at the test-of-cure visit and no appropriate material is available for culture from the original site of infection. • Superinfection. Any patient classified as clinically failed or clinically improved who has a pathogen isolated during therapy that is different than the original pathogen(s). • Colnnization. Isolation of an organism other than one isolated at baseline in a patient classified as a clinical cure. • Reinfection. Any patient classified as a clinical failure who has a pathogen isolated after the End-of-Treatment visit that is different than the original pathogen(s). • indeterminate. Any patient who cannot be classified into one of the above categories Measure:Efficacy Outcomes microbiological Timepoints:At the end-of-Treatment, and at a final visit after treatment (Long Term Follow-up). | — |
Countries
Peru
Outcome results
None listed