EUCTR2007-001491-36-IT进行中（未招募）不适用
''A prospective, randomized, open label, active comparator, multicenter, national trial to compare the efficacy and safety of sequential IV/PO moxifloxacin 400 mg once daily versus IV amoxicillin/clavulanate 2,0/0,2 g every 8 hours followed by oral amoxicillin/clavulanate 875/125 mg every 8 hours in the treatment of adult subjects with complicated skin and skin structure infections'' - MERAK
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
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 > or equal to 18 years with diagnosis of cSSSIs that requires:
- •- hospitalization,
- •- initial parenteral therapy for at least 48 h,
- •- complicated by at least one of the following criteria: involvement of deep soft tissues, requirement for a significant surgical intervention, association with a significant underlying disease that may complicate response to treatment, presence of SIRS.
- •Duration of infectione < 21 days
- •Diagnosis of one of the following SSSI:
- •- major abscess(es) associated with extensive cellulitis,
- •- erysipelaa and cellulitis,
- •- infected pressure ulcers,
- •- wound infection (including: postsurgical, post traumatic, human bite/clenched fist and animal bite, wound and wound associated with injection drug abuse).
- •- infected ischemic ulcers with at least one of the following conditions: diabetes mellitus, peripheral vascular disease, paraplegia or peripheral neurophaty.
- •Presence of at least 3 of the following local signs and symptoms: purulent drainage or discharge, erythema extended > 1 cm from wound edge, edema, pain or tenderness to palpation, swelling or induration, fever, CRP>20 mg/L.
- •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
- •Women who are pregnant or lactating
- •the following SSSI: necrotizing fasciitis including Fournier gangrene, ecthyma gangrenosus, streptococcal necrotizing fasciitis and clostridial necrotizing fasciitis , burn wound infection, secondary infections of a chronic a skin disease (es atopic dermatitis), infection of prosthetic materials, infections where a surgical procedure alone is definitive therapy, follicolitis, foruncolosis, carbuncolosis, simple abscessis and superficial cellulitis.
- •Known hypersensitivity to quinolones and/or any type of betalattam antibiotic drugs or any of the eccipients.
- •History of cholestatic jaundice/hepatic disfunction associated with amoxicillin/clavulanic acid
- •Severe life-threatening disease with a life expectancy <2 monthsi.
- •Immunosoppression including: known neutropenia , linfopenia, AIDS- defining event and/or concomitant therapy with HAART, chronic treatment > or equal 2 weeks with known con immunosuppressant therapy, any other difetto congenital or acquired immune defect or immunosuppression
- •severe hepatic insufficiency (Child-Pugh C) or transaminases increase > 5 fold ULN
- •renal impairment with baseline creatinine clearance <40 mL/min
- •Prolungation of QT interval or concomitant use of drugs reported to increase QT interval (class Ia or III antiarrhythmics quinidine, procainamide, amiodarone, sotalol), neuroleptics (haloperidol), tricyclic antidepressive agents, certain antimicrobials (pentamidine, halofantrine), antihistaminic (terfenadine), other drug (cisapride, vincamine IV, depridil, difemanil).
- •Ipokaliemia
- •relevant bradycardia
- •Relevant heart failure
- •Symptomatic arrhythmias
- •History of tendon disease/disorder with quinolones
- •Bacterial infections requiring additional sistemic antibacterial treatment (es. septic arthritis)
- •Therapy with probenecid
- •Treatmento with sistemic or topical antibacterial agent for > 24 h in the previous 7 days.
- •Infection to be due to a MRSA, MRSE, VRE as the single isolated pathogen.
研究者
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