EUCTR2007-003464-22-HU进行中（未招募）1 期
A randomized, Double-Blind, Active-Controlled, Parallel-Group, Noninferiority, Multicenter Study of Ceftobiprole Medocaril Versus Cefepime With or Without Vancomycin in the Treatment of Subjects With Fever and Neutropenia
Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium0 个研究点目标入组 340 人开始时间: 2007年9月26日最近更新:
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
- 340
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 18 years of age or older
- •Women must be postmenopausal (for at least 1 year), surgically sterile
- •(have had a hysterectomy or bilateral oophorectomy, tubal ligation, or
- •otherwise be incapable of pregnancy), abstinent, or, if sexually active, be
- •practicing an effective method of birth control (e.g., prescription oral
- •contraceptives, contraceptive injections, intrauterine device,
- •double-barrier method [e.g., condoms, diaphragm, or cervical cap with
- •spermicidal foam, cream, or gel], contraceptive patch, or male partner
- •sterilization) before entry and throughout the study; have a negative
- •serum ß-human chorionic gonadotropin (ß-hCG) or urine pregnancy test
- •(depending on local regulations) at screening.
- •Willing to adhere to the prohibitions and restrictions specified in this
- •protocol (see Section 4.4, Prohibitions and Restrictions)
- •Subjects must have signed an informed consent document indicating that
- •they understand the purpose of and procedures required for the study and
- •are willing to participate in the study.
- •Disease Specific
- •Neutropenia associated with administration of chemotherapy for cancer:
- •absolute neutrophil count (ANC) =500 cells/mm3. Subjects with
- •ANC <1,000 cells/mm3 within 48 hours after the onset of fever will be
- •enrolled only if their ANC is expected to further decrease to
- •<500 cells/mm3, based on clinical experience with the particular subject
- •or the chemotherapeutic regimen used to treat the subject. If the subject’s
- •ANC does not fall below 500 cells/mm3 within 48 hours of the onset of
- •fever then the study drug should be discontinued.
- •Fever: single oral temperature (or equivalent) =38.3°C (101°F) OR
- •temperature of =38.0°C (100.4°F) for at least 1 hour.
- •Require i.v. therapy for treatment of fever and neutropenia.
- •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
- •Have received an experimental drug or used an experimental medical
- •device within 30 days before the planned start of treatment.
- •Is pregnant or lactating.
- •Known or suspected hypersensitivity to any related anti-infective
- •(including vancomycin, or ß-lactam antibiotics such as penicillins and
- •cephalosporins).
- •Require only oral antibacterial therapy to treat their fever and neutropenia.
- •Have received more than 24 hours of oral or i.v. antibacterial treatment
- •for fever and neutropenia or have received systemic antibacterial therapy
- •in the previous 72 hours for a defined infectious disease. (Note: Subjects
- •receiving oral prophylaxis regimens will be eligible for enrollment
- •provided this prophylaxis began before the onset of fever).
- •Hepatic impairment, defined as an increase to greater than 4 times the
- •upper limits of normal for aspartate aminotransferase (AST) or ALT, or
- •greater than twice the upper limit for bilirubin.
- •Severe renal impairment (CLCR <25 mL per minute) or require dialysis.
- •Isolation, in the last 14 days, of pathogenic bacteria resistant to either
- •study drug therapy other than MR staphylococci.
- •Subjects who are moribund or who are unlikely to survive for at least
- •Subjects with shock (systolic blood pressure <90 mmHg) unresponsive to
- •fluid replacement.
- •Previously been entered into this study.
- •Poorly controlled seizure disorder.
- •Human immunodeficiency virus (HIV) infection.
- •Neutropenia syndromes that are not associated with chemotherapy for
- •cancer (e.g., chronic benign neutropenia).
- •Suspected or established infective endocarditis, empyema,
- •intra-abdominal infection, lung abscess, pneumonia secondary to
- •bronchial obstruction, meningitis, or osteomyelitis.
- •Complicated central venous catheter (CVC)-related infection (i.e., CVC
- •infection associated with septic thrombosis, endocarditis, or
- •osteomyelitis).
- •Likely to require major surgical intervention for infection
- •(i.e., amputation of infected limb, perforation of bowel with secondary
- •peritonitis).
- •Scheduled for or expected to receive granulocyte transfusions.
- •Employees of the investigator or study center, with direct involvement in
- •the proposed study or other studies under the direction of that investigator
- •or study center, as well as family members of the employees or the
- •investigator.
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A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Noninferiority, Multicenter Study of Ceftobiprole Medocaril Versus Cefepime With or Without Vancomycin in the Treatment of Subjects With Fever and NeutropeniaSubjects 18 years of age or older with fever and neutropenia after chemotherapy for cancer, who require i.v. therapy for treatment of fever and neutropeniaEUCTR2007-003464-22-BEJanssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium340