EUCTR2006-002257-76-ES进行中（未招募）1 期
ESTUDIO MULTICÉNTRICO, ALEATORIZADO Y DOBLE CIEGO, COMPARATIVO DE LA SEGURIDAD Y EFICACIA DE UNA DOSIS AL DÍA DE TIGECICLINA FRENTE A ERTAPENEM EN EL TRATAMIENTO DE LAS INFECCIONES DEL PIE DEL PACIENTE DIABÉTICOA Multicenter, Randomized, Double-Blind, Comparison Study of the Safety and Efficacy of a Once-Daily Dose of Tigecycline versus Ertapenem for the Treatment of Foot Infections in Subjects with Diabetes
Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 个研究点目标入组 1,065 人开始时间: 2010年3月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,065
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. Hospitalized male or female subjects >=18 years of age.
- •2. Subjects with diabetes mellitus per the American Diabetes Association (ADA) criteria.
- •3. Subjects with a foot infection that does not extend above the knee. If multiple infections meet all criteria below, the one with the highest IWGDF PEDIS grade for infection will be designated as the target.
- •4. Subjects with a foot infection that meets all of the following IWGDF PEDIS classifications (note: an ulcer is not required):
- •· Perfusion: grade 1 or 2;
- •· Infection: grades 2 to 4.
- •5. Subjects with anticipated need for IV antibiotic therapy of 5 days or longer.
- •6. Subjects whose foot infection has had an acute onset or worsening of signs and symptoms within the past 14 days.
- •7. Subjects who have received <= 48 hours administration of a potentially effective antibiotic (ie, active against all pathogens known to be present) to treat the current target infection.
- •8. Subjects who are considered to be therapeutic failures of prior antibiotic therapy with another agent may be enrolled if they have had worsening or no improvement in the clinical signs and symptoms of their diabetic foot infection and either have 1) a Gram stain from the infection site showing white blood cells and a potential pathogen or 2) culture results showing a pathogen resistant to prior antibiotics. Note: Subject may not have failed one of the study medications or any agent of the same class.
- •9. Osteomyelitis substudy arm only: Subjects who have presumptive evidence of osteomyelitis, defined as visible bone, a positive radiograph (ie, demineralization,
- •periosteal reaction, and bony destruction), or a positive probe-to-bone finding (as
- •described by Grayson et al) or confirmed evidence of osteomyelitis, defined as positive MRI (eg, decreased marrow signal on T1-weighted images, increased marrow signal on T2-weighted images, and contrast enhancement on T1-weighted postcontrast images) or positive bone biopsy.
- •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
- •1. Necrotizing fasciitis, crepitant cellulitis, wet gangrene, gas gangrene, ecthyma
- •gangrenosum, or severely impaired arterial supply to any portion of the affected foot.
- •2. Infected prosthetic materials or devices that will not be removed.
- •3. Suspected or known infection with a pathogen resistant to tigecycline or ertapenem ± vancomycin (eg, P. aeruginosa).
- •4. Subjects with
- •a. a diabetic foot infection without presumptive evidence of osteomyelitis (as
- •defined above) who are anticipated to need > 28 days of antibiotic treatment.
- •(primary study arm)
- •b. a diabetic foot infection with presumptive evidence of osteomyelitis (as defined
- •above) who are anticipated to need > 42 days of antibiotic treatment.(osteomyelitis substudy arm)
- •5. Anticipated requirement for complete resection or amputation (ie, removal of all infected tissue with clean margins) of the infected anatomical site within 1 month (30 days).
- •Note: Subjects who will have all infected bone removed, but still have a skin infection
- •may be randomized to the primary study arm after the removal of the infected bone.
- •6. Concurrent hemodialysis, hemofiltration, peritoneal dialysis or plasmapheresis.
- •7. 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 (eg, life expectancy < 30 days).
- •8. Subjects with contraindication or hypersensitivity to any of the test articles or related antibiotics.
- •9. Presence of any of the following laboratory findings:
- •a. Neutropenia with absolute neutrophil count <1 x 10x9/L [<1000/mm3]
- •b. Presence of significant hepatic disease:
- •i. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) >10 x the upper limit of normal (ULN);
- •ii. Total bilirubin > 3 x the ULN;
- •iii. Acute hepatic failure or acute decompensation of chronic hepatic failure.
- •c. Creatinine clearance (ClCR) < 30 mL/min, Creatinine clearance may be calculated
- •from the serum creatinine (SCR) concentration by the following equation:
- •Male: ClCR mL/min = (140-age) x weight (kg) / (72 x SCR [mg/dL])
- •Female: ClCR mL/min = 0.85 x ([140-age] x weight [kg] / [72 x SCR {mg/dL}]).
- •10. Known or suspected concurrent infection that would require treatment with a systemic antibacterial agent(s).
- •11. Any investigational drugs taken or investigational devices used within 4 weeks before the first dose of IV test article administration.
- •12. Previous participation in this study.
- •13. Pregnant or breastfeeding women.
- •14. Women of childbearing potential who do not agree either to practice sexual abstinence or use a medically acceptable method of contraception throughout the duration of the study and for at least 1 month (30 days) after the last day of IV test article administration. A woman of childbearing potential is one who is biologically capable of becoming pregnant; this includes women who are using contraceptives or those women whose sexual partners are either considered sterile or using contraceptives.
- •15. Subjects taking immunosuppressive therapy, defined as chronic treatment with known immunosuppressive medications (including the use of > 40 mg of prednisone or its equivalent per day for >3 weeks before randomization), or any severely
- •immunocompromised subjects.
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