EUCTR2014-000545-78-BG进行中（未招募）1 期
A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF CARBAVANCE™ (MEROPENEM/RPX7009) COMPARED TO PIPERACILLIN/TAZOBACTAM IN THE TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS, INCLUDING ACUTE PYELONEPHRITIS, IN ADULTS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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. A signed informed consent form, the ability to understand the study
- •conduct and tasks that are required for study participation, and a
- •willingness to cooperate with all tasks, tests, and examinations as
- •required by the protocol.
- •2. Male or female = 18 years of age.
- •3. Weight = 185 kg.
- •4. Expectation, in the judgment of the Investigator, that the subject's
- •cUTI or AP requires initial treatment with at least 5 days of IV
- •antibiotics.
- •5. Documented or suspected cUTI or AP as defined in the protocol.
- •6. Expectation, in the judgment of the Investigator, that any indwelling
- •urinary catheter or instrumentation (including nephrostomy tubes
- •and/or indwelling stents) will be removed or replaced (if removal is not clinically acceptable) before or as soon as possible, but not longer than
- •12 hours, after randomization.
- •7. Expectation, in the judgment of the Investigator, that the subject will
- •survive with effective antibiotic therapy and appropriate supportive care
- •for the anticipated duration of the study.
- •8. Women of childbearing potential must have a negative pregnancy test
- •before randomization, and be willing to use a highly effective method of
- •contraception between randomization and for 7 days after the
- •completion of the study. A highly effective method of contraception
- •includes two of the following: hormonal implants/patch, injectable
- •hormones, oral hormonal contraceptives, prior bilateral oophorectomy,
- •prior hysterectomy, prior bilateral tubal ligation, intra-uterine device,
- •approved cervical ring, condom, true abstinence (if approved by the
- •Investigator), or a vasectomized partner.
- •9. Willingness to comply with all the study procedures, whether in the
- •hospital or after discharge, for the duration of the study.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. Presence of any of the following conditions:
- •a. Perinephric abscess
- •b. Renal corticomedullary abscess
- •c. Uncomplicated UTI
- •d. Polycystic kidney disease
- •e. Chronic vesicoureteral reflux
- •f. Previous or planned renal transplantation
- •g. Subjects receiving hemodialysis
- •h. Previous or planned cystectomy or ileal loop surgery; or
- •i. Known candiduria
- •2. Presence of suspected or confirmed acute bacterial prostatitis, orchitis, epididymitis, orchronic bacterial prostatitis as determined by history and/or physical examination
- •3. Gross hematuria requiring intervention other than administration of
- •4. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required to relieve an obstruction or place a stent or nephrostomy)
- •5. Renal function at screening as estimated by creatinine clearance <30 mL/min using the Cockcroft-Gault formula
- •6. Known non-renal source of infection such as endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to randomization
- •7. Any of the following signs of severe sepsis:
- •a. Shock or profound hypotension defined as systolic blood pressure <90
- •mmHg or a decrease of >40 mmHg from baseline (if known) that is not
- •responsive to fluid challenge
- •b. Hypothermia (oral or tympanic temperature <35.6°C [<96.1°F] or rectal/core temperature <35.9°C [<96.6°F])
- •c. Disseminated intravascular coagulation as evidenced by prothrombin time or partial thromboplastin time = 2 × the upper limit of normal (ULN) or platelets <50% of the lower limit of normal.
- •8. Pregnant or breastfeeding women
- •9. History of epilepsy or known seizure disorder requiring current treatment with anti-seizure medication
- •10. Treatment within 30 days prior to enrollment with valproic acid
- •11. Treatment within 30 days prior to enrollment with probenecid
- •12. Treatment within 30 days prior to enrollment with any cancer chemotherapy, immunosuppressive medications for transplantation, or medications for rejection of transplantation
- •13. Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis or hepatic encephalopathy
- •14. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>3 × ULN, or total bilirubin > 1.5 × ULN
- •15. Receipt of any investigational medication or investigational device during the last 30 days prior to randomization
- •16. Prior exposure to RPX7009 alone or in combination with another product
- •17. Receipt of any potentially therapeutic antibiotic agent within 48 hours before randomization. EXCEPTIONS - please refer to the Protocol
- •18. Requirement at time of enrollment for any reason for additional systemic antibiotic therapy (other than study drug) or antifungal therapy. Topical antifungal or a single oral dose of any antifungal treatment for vaginal candidiasis will be allowed
- •19. Likely to require the use of an antibiotic for cUTI prophylaxis during the subject's participation in the study (from enrollment through the LFU visit)
- •20. Known history of human immunodeficiency virus infection with a CD4 count <200/mm3
- •21. Presence of immunodeficiency or an immunocompromised condition including hematologic malignancy, bone marrow transplant, or receiving immunosuppressive therapy such as cancer chemotherapy, medications for the rejection of transplantation, and long-term ( = 2 weeks) use of systemic corticosteroids. (equivalent to = 20 mg a day of prednisone or systemic equivalent for = 2 weeks)
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