INEZOLID COMPARED WITH CEFADROXIL IN THE TREATMENT OF SKIN INFECTIONS AND SOFT PARTS NOT COMPLICATED IN CHILDRE
- Conditions
- -L089 Local infection of skin and subcutaneous tissue, unspecifiedLocal infection of skin and subcutaneous tissue, unspecifiedL089
- Registration Number
- PER-025-00
- Lead Sponsor
- PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
General Criteria
• Male or female patients between 5 and 17 years of age.
• At the time of admission, patients must have an expectation of survival with effective antibiotic therapy and regular medical care during the study.
• Patients must be willing to complete all activities related to the study. The patient´s parent / legal guardian will arrange for the patient to return to all required visits, and will respond to questions regarding adverse events.
• Be able to receive medication orally.
• If the patient is infected with the AIDS virus (HIV), the CD4 cell count should be> 200 cells / mm3.
Skin infection and uncomplicated soft parts
• Clinical picture compatible with a diagnosis of uncomplicated skin / soft tissue infection that is presumed to be caused by a gram-positive bacterium with at least two of the following signs and symptoms: drainage / drainage, erythema, fluctuation, localized heat / heat, pain / sensitivity to palpation, inflammation / induration
• An accessible site for obtaining the sample in order to perform Gram stain and culture, and define the microbiological etiology.
• Abscess that, at the moment of patient´s admission, requires more than a simple surgical drainage.
• The treatment with the comparator is considered appropriate.
• More than 24 hours of treatment with a potentially effective systemic antibiotic within 48 hours of admission to the study, unless the treatment has failed (failure is defined as lack of clinical improvement after 3 days of treatment), or that the pathogen has shown resistance to the drug.
• Infection (s) with a high rate of cure by surgical incision, eg, folliculitis, isolated furunculosis.
• Medical conditions in which inflammation may be prominent for a prolonged period, even after successful bacterial eradication, eg, superinfected eczema or atopic dermatitis.
• Infection (s) requiring concomitant systemic corticosteroid therapy, or a potentially effective concomitant antimicrobial.
• Ischemic ulcers and decubitus (unless there is an associated cellulitis), necrotizing fasciitis, gas gangrene, or burns that occupy more than 20% of the total body surface.
• Orbital, buccal or facial cellulitis (unless it is related to a traumatic injury or other obvious skin wound), which is presumed to be due to Haemophilus Influenzae type B or another gram-negative pathogen.
• Infection caused by organisms known to be resistant to the study drugs. Patients can be admitted to the study with their culture results and pending baseline sensitivity analysis.
• Patients whose absolute baseline neutrophil count is <500 / P-1.
• Patients with infected devices that will not be removed.
• Endocarditis, osteomyelitis / septic arthritis, and infections of the Central Nervous System.
• Evidence of pheochromocytoma, carcinoid syndrome, untreated hyperthyroidism, or uncontrolled hypertext.
• Known or suspected leukemia.
• Hypersensitivity to linezolid or cefadroxil, or to one of the excipients in the formulation of both drugs
• Admission prior to this protocol or another linezolid protocol.
• Concurrent use of another medication under investigation.
• Women of childbearing age should not breastfeed their babies, and should have a negative pregnancy test at the baseline visit before receiving any study medication; also, they must use adequate contraceptive methods in order to avoid becoming pregnant during the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method