EUCTR2005-004250-28-PT进行中（未招募）不适用
A MULTICENTER, RANDOMIZED, OPEN-LABEL COMPARISON OF THE SAFETYAND EFFICACY OF TIGECYCLINE WITH THAT OF AMPICILLIN-SULBACTAMOR AMOXICILLIN-CLAVULANATE TO TREAT COMPLICATED SKIN AND SKINSTRUCTURE INFECTIONS.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- •1. Male and female subjects, 18 years of age or older.
- •2. Anticipated need for in-patient intravenous antibiotic therapy of 4 days or longer.
- •3. Male or non-pregnant, non-lactating female who is postmenopausal, surgically sterilized, or is using reliable method of birth control (eg, hormonal birth control, intrauterine device [IUD], double barrier [male condom, female condom, diaphragm] or a barrier method plus a spermicidal agent [contraceptive foam, jelly, or cream] or abstinence). A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Effective contraception should have been in place for at least 2 months prior to study entry. All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control or sexual abstinence for the duration of the study and for 30 days after the last dose of Test Article.
- •4. A serum or urine laboratory pregnancy test must be negative at baseline for all women of childbearing potential. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
- •5. Subjects known or suspected to have a complicated skin and skin structure infection. Complicated skin/skin structure infection includes infections involving deeper soft tissue or requiring significant surgical intervention, or a significant underlying disease state (such as diabetes mellitus, peripheral vascular disease, peripheral neuropathy, venous insufficiency) that complicates response to treatment. This would include clinical entities such as one of the following:
- •a. Infected ulcers that have developed signs of erythema, swelling, tenderness, pus or warmth.
- •b. Burns (<5% body surface area, non-full thickness).
- •c. Major abscess (not treatable through surgery and wound care alone).
- •d. Deep or extensive cellulitis either in an underlying disease state or greater than 10 cm in width or length where anatomically feasible, or the presence of drainage or discharge.
- •e. Peripheral intravenous catheter sites with documented purulent drainage, provided the catheter line will be removed.
- •f. Infected human or animal bites.
- •6. Subjects must have at least two of the following signs and symptoms:
- •a. Drainage and/or discharge.
- •b. Fever defined as an oral temperature > 37.8° C (100° F), a tympanic temperature > 38.2° C (100.8° F), or a rectal temperature >38.4° C (101.0° F) or hypothermia defined as an oral, tympanic or axillary temperature < 35.5° C (95.9° F), or a rectal temperature < 36.0° C (96.8° F), within the 24 hours prior to enrollment.
- •c. Erythema.
- •d. Swelling and/or induration.
- •e. Localized warmth.
- •f. Pain and/or tenderness to palpation.
- •g. Leukocytosis defined as white blood cell count (WBC) >10,000/mm3, or >10% immature (band) forms.
- •7. Subjects who have not received more than two doses of any given non-study antibacterial drug after the original culture of the infected site was obtained except for subjects considered prior antibiotic failures.
- •8. For subjects who are considered therapeutic failures for prior antibiotic therapy with another agent at entry, a baseline culture of the infected site must be obtained before the first dose of Test Article is administered (see Section 12.0, Prior Treatm
排除标准
- •1. Subjects with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed.
- •2. An uncomplicated skin and/or skin structure infection (eg, simple abscesses, folliculitis, impetiginous lesions, furunculosis, superficial cellulitis).
- •3. Subjects with a skin and/or skin structure infection that can be treated by surgery and wound care alone.
- •4. Clinical presence or suspicion of any of the following:
- •a. Ecthyma gangrenosum.
- •b. Necrotizing fasciitis or gangrene.
- •c. Osteomyelitis or septic arthritis contiguous to the infected site.
- •d. Crepitant cellulitis (gas gangrene).
- •5. Subjects with severely impaired arterial blood supply and insufficiency such that the likelihood of amputation of the infected anatomical site within 1 month is likely.
- •6. Infected chronic diabetic foot ulcers or decubitus ulcers where the documented infection is present for >1 week.
- •7. Presence of any known or suspected concomitant bacterial infection requiring additional systemic antimicrobial therapy. Subjects with suspected or known Pseudomonas aeruginosa infections. However, subjects in whom the initial wound culture shows evidence of P aeruginosa infection may continue to receive Test Article at the investigator’s discretion if the subject shows signs of substantial and continuous clinical improvement on a daily basis.
- •8. Subjects with underlying immunodeficiency disease or subjects requiring chronic treatment with known immunosuppressant medications that, in the opinion of the investigator, would decrease the subjects’ ability to eradicate the infection (eg, systemic corticosteroids equivalent to >40 mg/day of prednisone).
- •9. Concurrent plasmapheresis or hemoperfusion.
- •10. Known or suspected hypersensitivity to tigecycline, beta-lactams (ampicillin or amoxicillin), sulbactam, clavulanate, vancomycin, teicoplanin, or tetracycline- or comparator-like drugs.
- •11. Presence of any of the following laboratory findings:
- •a. Neutropenia (absolute neutrophil count [ANC] <1000/mm3);
- •b. Presence of hepatic disease:
- •· Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels >10 x upper limit of normal (ULN) values.
- •· Bilirubin level >3.0 x ULN.
- •· Subjects with acute hepatic failure or acute decompensation of chronic hepatic failure are excluded.
- •c. Creatinine clearance of <30 mL/min after adequate hydration. Creatinine clearance (Clcr) may be estimated from the serum creatinine (Scr) concentration by the following equation:
- •Male: Clcr = [(140-age) x weight (kg) mL/min]/ 72 x Scr (mg/dL)]
- •Female: Clcr = 0.85 x Clcr derived by the above formula
- •12. Subjects with prior or planned concomitant treatment with probenecid within 7 days; or any investigational drugs taken within 4 weeks before administration of the first dose of TA (Day 1).
- •13. Previous participation in this study.
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