PER-025-00已完成未知
INEZOLID COMPARED WITH CEFADROXIL IN THE TREATMENT OF SKIN INFECTIONS AND SOFT PARTS NOT COMPLICATED IN CHILDRE
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,0 个研究点目标入组 0 人开始时间: 2000年4月18日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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