PER-067-05已完成未知
Phase 2, Multicentric, Randomized, with Blind Observer Study, to Evaluate the Safety and Efficacy of PPI-0903 versus Standard Treatment in Adult Subjects with Complicated Skin and Skin Structures Infections
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- CEREXA INC.,
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
- 0 至 0（—）
入选标准
- •1. Men and women> 18 years of age
- •2. Complicated infection of the skin or structures of the skin.
- •3. Clinical findings: I. Local signs at the cSSSI site. II. Systemic signs
- •4. Requirements for treatment: I. The infection and / or condition of the patient would require, according to the standard of treatment, the initial hospitalization. II. The infection of the subject would require, according to the standard of treatment, the administration of IV antimicrobials.
排除标准
- •1. History of any type of hypersensitivity or allergic reaction to any B-lactam antibiotic.
- •2. History of any type of hypersensitivity or allergic reaction to any sulphite.
- •3. History of any type of hypersensitivity or allergic reaction to vancomycin or a history of red man syndrome.
- •4. Current or past history of epilepsy or convulsive disorder.
- •5. More than a single dose of an antibiotic that does not belong to the study.
- •6. Pre-existing Gram-positive infection with known or suspected resistance to vancomycin or Gram-negative infection with known or suspected resistance to aztreonam or ceftriaxone.
- •7. Furunculosis, carbunculosis or folliculitis.
- •8. Infection of the skin and structures of the skin: a) With known or suspected presence of anaerobic pathogens. b) With known or suspected presence of fungal, parasitic or viral pathogens. c) With a known or suspected presence of Pseudomonas aeruginosa as a contributing pathogen. d) Which comprises an ischemic ulcer due to PVD. e) That includes a decubitus ulcer. f) That comprises a diabetic foot ulcer.
- •9. Infections of the skin and structures of the skin with a high rate of healing after the surgical incision.
- •10. Infections of the skin and skin structures of the same type in separate and distinguishable anatomical sites.
- •11. Known or suspected infections related to the cSSSI, but present or originated in other sites or anatomical spaces.
- •12. Requirement for antibacterial or systemic antifungal therapy.
- •13. Requirement for concomitant treatment with valproic acid or probenecid.
- •14. Probenecid administration in the previous 3 days.
- •15. Requirement for concomitant treatment with Class Ia antiarrhythmic agents.
- •16. Infection or disorders that require systemic corticosteroids.
- •17. Impaired renal function.
- •18. Evidence of significant respiratory, hepatic or hematologic disease.
- •19. Evidence of immediate potentially fatal disease.
- •20. Evidence of significant heart disease.
- •21. History of nephrolithiasis.
- •22. Life expectancy of less than 3 months.
- •23. Women who are pregnant, who are breastfeeding, or if they have reproductive potential, do not use a clinically accepted method of birth control.
- •24. Participation in any study that involves the administration of an agent in research within the previous 30 days.
- •25. Previous participation in a study of PPI-0903.
- •26. Can not or is not willing to observe the specific procedures and restrictions of the study.
- •27. Has a condition that would compromise the patient´s safety or the quality of the data.
研究者
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