EUCTR2014-001276-56-GR进行中（未招募）1 期
A prospective, open label, randomised controlled clinical trial, with pharmacokinetic-pharmacodynamic validation, to compare antimicrobial treatment with oral minocycline plus rifampicin to treatment with oral linezolid for complicated skin and skin structure infections (cSSSI) caused by Methicillin resistant Staphylococcus aureus (MRSA). - AIDA/HSSG, Version 1, 26 Nov 2013
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 225
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
- •Patients will be enrolled in this study only if they meet all of the following numbered criteria:
- •1.Hospitalised with clinical evidence of at least 1 of the following MRSA infections:
- •First or second degree burns of less than 20% of body surface area with concomitant signs of cellulitis (excluding third degree burns and burns >20% of body surface area)
- •Major abscess (see exclusion criteria for qualifications)
- •Deep or extensive cellulitis, and/or
- •Wounds – trauma or post-surgical
- •2.Presence of purulent or seropurulent drainage or at least 3 of the following signs and symptoms:
- •Drainage and/or discharge
- •Erythema (extending at least 1 cm beyond a wound edge)
- •Swelling and/or induration
- •Heat and/or localized warmth
- •Pain and/or tenderness to palpation
- •3.At least 1 of the following conditions considered to be pathogen-related:
- •Fever (temperature >38 C/100.4 F orally, rectally, or tympanically),
- •Elevated total peripheral white blood cells (WBCs) >10,000/mm3, or
- •>15% immature neutrophils (bands), regardless of total peripheral WBC count
- •4.Accessible infection site for culture or a bacteraemia where a culture cannot be obtained from the site of infection
- •5.Adult at least 18 years of age
- •6.Written informed consent to participate in the study before any study-specific procedures are performed
- •7.If of childbearing potential, must be using, or be prepared to use, a mechanical method of contraception (e.g. condom) during the study.
- •8.If female, has a negative serum pregnancy test (serum beta-human Chorionic Gonadotropin (hCG)) result immediately prior to enrolment. If obtaining the serum pregnancy result would cause a delay in treatment, the patient can be entered on the basis of a negative urine pregnancy test result. The urine pregnancy test must be sensitive to at least 50 mU/mL of beta-hCG, pending results of the serum test. The patient must end study medication therapy if the subsequent serum pregnancy test is positive
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Any of the following will exclude a patient from enrolment into the study.
- •1.Women who are pregnant or breast-feeding
- •2.Pre-menopausal women who refuse to substitute oral contraception during treatment by contraception using mechanical means (e.g. condom)
- •3.Known or suspected hypersensitivity to linezolid, minocycline or rifampicin
- •4.Clinical or laboratory evidence of significant impairment of hepatic function, i.e. bilirubin of >3x upper limit of normal range, AST or ALT >5x upper limit of normal range, proven histological liver changes on biopsy
- •5.Major abscess associated with diabetic foot conditions
- •6.Suspected or confirmed osteomyelitis
- •7.Treatment with other antimicrobials with activity against MRSA within 24hr prior to study inclusion. However, treatment failures from other therapy may be entered provided there is a positive baseline culture for MRSA.
- •8.In the case of a mixed infection where it is considered necessary to concomitantly treat with a Gram-negative agent, this agent must have no activity against MRSA.
- •9.Patients with a high probability of death within a week of study entry
- •10.Haemodialysis patients or those requiring other means of renal support for end stage renal disease.
研究者
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