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 <br>Outcome name:Clinical results<br>• Cured: Resolution of clinical signs and symptoms of the infection, compared with baseline.<br>• Improved: Incomplete resolution of clinical symptoms.<br>• Failure: Persistence, incomplete resolution, or worsening of the baseline clinical signs and symptoms of the infection; development of new signs and symptoms congruent with an active infection, which require additional antimicrobial therapy.<br>• Undetermined: Mitigating circumstances preclude classification as One of the results cited above. Patients who require incision and drainage after more than 48 hours of the first dose of study medication should also be classified as indeterminate.<br>Measure:Efficacy<br>Timepoints:On Day 7, in the End of Treatment visit, and in the Follow-up visit.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:An acceptable risk / benefit ratio for linezolid in the treatment of gram-positive bacterial infections is based on the clinical evaluations planned to detect adverse reactions to the drug. Changes in physical findings, as well as signs and symptoms that may reflect adverse effects, will be documented throughout the treatment and post-treatment period. In addition, all adverse events will be recorded.<br>Measure:Safety<br>Timepoints:During the treatment and post-treatment period.<br>