INEZOLID VS OXACILINA SODIUM/DICLOXACILINA SODIUM FOR THE TREAMENT OF COMPLICATED SKIN AND SOFT TISSUES INFECTIONS

Not Applicable

• Conditions: -L088 Other specified local infections of skin and subcutaneous tissue; Other specified local infections of skin and subcutaneous tissue; L088

• Registration Number: PER-008-98
• Lead Sponsor: PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1998-09-30
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified