PER-074-05已完成未知
PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF CEFTOBIPROLE MEDOCARIL VERSUS LINEZOLID PLUS CEFTAZIDINE IN THE TREATMENT OF NOSOCOMIAL PNEUMONIA
JHONSON & JHONSON PHARMACEUTICALS,0 个研究点目标入组 0 人开始时间: 2006年1月16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
- 年龄范围
- 18 至 0（—）
- 性别
- All
入选标准
- •1) Informed consent granted in writing. The consent of patients in a state of unconsciousness / incapacity may be granted by their direct relatives, guardians or legal representatives.
- •2) Subjects men and women ≥ 18 years of age.
- •3) Before beginning and throughout the entire study, women should be postmenopausal, surgically sterile or be practicing some effective method of birth control and the pregnancy test should be negative.
- •4) Subjects suffering from NP or VAP.
- •5) Microbiological samples suitable for culture and microscopy.
- •6) APACHE II score ≥ 8 and ≤ 25.
排除标准
- •1. Subjects women who are pregnant or breastfeeding.
- •2. Known or suspected hypersensitivity to any medication of the
- •3. Any known or suspected concurrent treatment or treatment contraindicated by the prescription information of linezolid or ceftazidime.
- •4. Severe deterioration of renal function.
- •5. Known or suspected hepatic dysfunction.
- •6. Baseline QTcB (Bazett correction)> 450 msec.
- •7. Previous enrollment in this study.
- •8. Treatment with any investigational medication within 30 days prior to enrollment.
- •9. Any other known or suspected disease of the subject, which could jeopardize compliance with the requirements of the protocol.
- •10. Known HlV-positive with count of ≤ 200 cells / mm3.
- •11. Presence of myelosuppression or neutropenia, severe anemia.
- •12. Children or other family members of the researcher or employees of the study center.
- •13. Sustained shock.
- •14. Subjects with: a) Confirmed bronchial obstruction or a history of postobstructive pneumonia, primary lung cancer or other metastatic malignancy of the lungs. b) Cystic fibrosis. c) Lung abscess. c) Pleural effusion as a source of primary infection. e) Active tuberculosis. f) Subjects that require antibiotic coverage due to aspiration pneumonia, atypical pneumonia or Pneumocystis jiroveci pneumonia.
- •15) Systemic antimicrobial therapy for more than 24 hours within 7 days prior to enrollment.
- •16) Evidence in available control cultures of coinfection with pathogens such as: Producers of ESBL, Proteus vuigaris and non-fermentors resistant to ceftazidime or ceftobiprole.
研究者
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