NCT00711854已完成4 期
Randomized Clinical Trial to Compare a Regimen of Trimethoprim-sulfamethoxazole (TMP-SMX) Plus Rifampicin With a Regimen of Linezolid in the Treatment of Infections Caused by Methicillin-resistant Staphylococcus Aureus (MRSA)
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Bacteriological and clinical cure
研究概览
简要总结
MRSA infections often require systemic antibiotic therapy and represent an important healthcare burden. Currently available treatment options are either only available in parenteral form (vancomycin) or expensive (linezolid). Thus, there is an urgent, unmet need to better investigate in-expensive but highly active alternatives to currently recommended standard treatment options. The purpose of the proposed study is to test the hypothesis that a combination of TMP-SMX and rifampicin is not inferior to linezolid for treatment of MRSA infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patients with clinical signs and symptoms of MRSA-related infection
- •Culture of MRSA (predominant microorganism in culture) susceptible to all of the following:
- •rifampicin
- •linezolid
- •Patient must give written informed consent to participate in the study.
排除标准
- •Women who are pregnant or nursing
- •Women who refuse to substitute oral contraception during treatment
- •Known or suspected hypersensitivity to linezolid, TMP-SMX or rifampicin
- •Clinical or laboratory evidence of significant impairment of hepatic function, as demonstrated by any of the following criteria:
- •Bilirubin > 3 x upper limit of normal range
- •AST or ALT > 5 x upper limit of normal range
- •Acute hepatitis or proven liver cirrhosis by liver histology
- •Treatment with other antimicrobials with activity against MRSA for > 72 hours prior to study inclusion
- •Patients with a high probability of death within the week following study entry
- •Patients who, in the opinion of the investigator, cannot be relied upon for post-therapy follow-up
- •Patients requiring alternative antibiotic therapy with anti-MRSA activity. However, if another antibiotic treatment without antistaphylococcal activity is necessary, the patient is acceptable for randomization. In that sense, the use of aztreonam (against Gram negative microorganisms) or metronidazole (against anaerobes) is allowed
- •Hemodialyzed patients
- •History of pheochromocytoma, carcinoid syndrome, untreated hyperthyroidism, uncontrolled hypertension, or patients receiving serotonin uptake inhibitors
- •Severe thrombocytopenia (< 50.000 platelets)
- •Left-sided endocarditis with a poor prognosis (patients aged over 50; cerebral embolism)
- •Chronic osteomyelitis without surgical debridement; superinfected indwelling foreign body, deliberately kept in place
- •Patients with severe sepsis or septic shock due to MRSA bacteremia
- •Patients who receive any of the following drugs, which cannot be substituted or temporarily withdrawn: adrenergic and serotonergic agents, tramadol, pethidine, duloxetine, venlafaxine, milnacipran, sibutramine, chlorpheniramine, brompheniramine, cyproheptadine, citalopram, and paroxetine.
研究组 & 干预措施
1
Experimental
trimethoprim-sulfamethoxazole (TMP-SMX) plus rifampicin
干预措施: trimethoprim-sulfamethoxazole (TMP-SMX) (Drug)
1
Experimental
trimethoprim-sulfamethoxazole (TMP-SMX) plus rifampicin
干预措施: Rifampicin (Drug)
2
Active Comparator
Linezolid
干预措施: Linezolid (Drug)
结局指标
主要结局
Bacteriological and clinical cure
时间窗: 6 weeks
次要结局
- Treatment costs(6 weeks)
研究者
Stephen Harbarth
Professor
University Hospital, Geneva
研究点 (1)
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