EUCTR2006-001599-18-IT进行中（未招募）不适用
A prospective, randomized, double dummy, double blind, multinational, multicenter trial comparing the safety and efficacy of sequential intravenous/oral moxifloxacin 400 mg once daily to intravenous piperacillin/tazobactam 4.0/0.5 g every 8 hours followed by oral amoxicillin/clavulanic acid tablets 875/125 mg every 12 hours for the treatment of subjects with complicated skin and skin structure infections RELIEF study - RELIEF
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- BAYER
- 入组人数
- 804
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Men or women of age 18 years of age with a diagnosis of bacterial skin and skin structure infection that requires Hospitalization and Initial parenteral therapy for at least 48 hours and Meets at least one of the following criteria 1 Involvement of deep soft tissue eg, fascial, muscle layers 2 Requirement for a significant surgical operation 3 Association with a significant underlying disease that may complicate response to treatment. An underlying disease is considered significant if it includes any of the following conditions that are present at the time of presentation cancer except basal- or squamous-cell cancer of the skin , cardiac ie, congestive heart disease , diabetes mellitus, hepatic ie, cirrhosis or another form of chronic liver disease , immunologic, renal disease, respiratory, transplantation or vascular disease. Duration of infection 21 days. Diagnosis of one of the following skin and skin structure infections that requires hospitalization and initial parenteral antibiotic therapy for at least 48 hours a. Major abscess es associated with extensive cellulitis, b. Diabetic foot infection of mild to severe intensity c. Wound infection including
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects with any of the following will be excluded from the study 1. Women, who are pregnant or lactating. 2. The following skin and skin structure infections a. Necrotizing fasciitis. b. Burn wound infections. c. Secondary infections of a chronic skin disease eg, atopic dermatitis . d. Infection of prosthetic materials. e. Infections where a surgical procedure alone is definitive therapy. f. Subjects with uncomplicated skin and skin structure infections. 3. Known hypersensitivity to quinolones and/or any type of beta-lactam antibiotic drugs or any of the excipients. 4. Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillinclavulanic acid. 5. Severe, life-threatening disease with a life expectancy of less than 2 months. 6. Immunosuppression including a. Known neutropenia neutrophil count 1000/ 61549;L . b. Known lymphopenia with absolute CD4 T-cell count 200/mm3. c. AIDS-defining event and/or concomitant therapy with HAART. d. Chronic treatment 61619; 2 weeks with known immunosuppressant therapy including treatment with 15 mg/day of systemic prednisone or equivalent . e. Any other congenital or acquired immune defect or immunosuppression. 7. Known severe hepatic insufficiency Child-Pugh C or transaminases increase 5 fold upper limit of normal ULN . 8. Known renal impairment with a baseline measured or calculated serum creatinine clearance 40 mL/min . 9. Known prolongation of the QT interval or concomitant use of drugs reported to increase the QT interval eg, Class IA or Class III antiarrhythmics eg., quinidine, procainamide, amiodarone, sotalol , neuroleptics eg., haloperidol , tricyclic antidepressive agents, certain antimicrobials eg, pentamidine, halofantrine , certain antihistaminics eg., terfenadine , and other cisapride, vincamine IV, depridil, diphemanil . 10. Uncorrected hypokalemia. 11. Clinically relevant bradycardia. 12. Clinically relevant heart failure with reduced left-ventricular ejection fraction ie, below 40 . 13. Previous history of symptomatic arrhythmias. 14. Previous history of tendon disease/disorder with quinolones. 15. Known or suspected concomitant bacterial infection requiring additional systemic antibacterial treatment, eg, underlying septic arthritis. 16. Requiring therapy with probenecid. 17. Treatment with a systemic or topical antibacterial agent for 24 hours in the previous 7 days preceding study entry unless the subject showed no response or had worsening of clinical signs and symptoms despite 3 or more days of prior therapy and a culture obtained at the time of subject enrollment showed persistence of a pathogen which is susceptible to the study drugs. The prior antimicrobial therapy must not have been a fluoroquinolone or a beta-lactam/beta-lactamase combination. 18. Infection known to be due to a MRSA, MRSE or VRE as the single isolated pathogen. 19. Previous enrolment in this study. 20. Participation in any clinical investigational drug study within 4 weeks of screening.
研究者
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