跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/EUCTR2014-000545-78-SI
EUCTR2014-000545-78-SI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 - Tango I

Rempex Pharmaceuticals, Inc.0 个研究点目标入组 500 人开始时间: 2015年4月16日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
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
研究概览入排标准研究者记录与标识符相似试验

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, or chronic bacterial prostatitis as determined by history and/or physical examination.
  • •3.Gross hematuria requiring intervention other than administration of study drug.
  • •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]); or
  • •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
  • •17.Receipt of any potentially therapeutic antibiotic agent within 48
  • •hours before randomization. EXCEPTIONS:
  • •Subjects who received a single dose of a short-acting oral or IV antibiotic (no more than 25% of subjects)
  • •Subjects who received >48 hours of prior systemic AB therapy for the current episode of cUTI with unequivocal clinical evidence of treatment failure (i.e., worsening signs and symptoms)
  • •Subjects who develop signs and symptoms of cUTI or AP while on antibiotics for another indication
  • •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 HIV infection with a CD4 count <200/mm3
  • •21.Presence of i

研究者

相似试验

进行中（未招募）
1 期
A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIOMedDRA version: 9.1Level: HLTClassification code 10037401Term: Pulmonary hypertensionsPulmonary arterial hypertension
EUCTR2008-005885-30-SKPfizer Limited150
进行中（未招募）
1 期
A randomized, double-blind double-dummy Phase 3 study performed at multiple study sites to evaluate the safety, efficacy and tolerability of the combinational product Carbavance (Meropenem/RPX7009) in comparison to Piperacillin/Tazobactam which is already approved in many countries to treat patients with complicated urinary tract infections, including acute pyelonephritis, in adults.complicated urinary tract infection (cUTI) or acute pyelonephritis (AP) with or without concurrent bacteremiaMedDRA version: 18.0Level: PTClassification code 10037597Term: Pyelonephritis acuteSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 18.0Level: HLTClassification code 10046577Term: Urinary tract infectionsSystem Organ Class: 10021881 - Infections and infestations
EUCTR2014-000545-78-HURempex Pharmaceuticals, Inc.850
尚未招募
不适用
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-N10 Acute tubulo-interstitial nephritis-N390 Urinary tract infection, site not specifiedUrinary tract infection, site not specifiedN390
PER-002-15REMPEX PHARMACEUTICALS Inc. subsidiaria de propiedad total de The Medicines Company,18
进行中（未招募）
1 期
A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertensionPulmonary Arterial Hypertension
EUCTR2008-005887-14-SKPfizer Limited, Ramsgate Road, Sandwich, Kent, UK150
进行中（未招募）
不适用
A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED 26-WEEK TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF DIMEBON (LATREPIRDINE, PF-01913539) IN PATIENTS WITH MODERATE-TO-SEVERE ALZHEIMER’S DISEASEMedDRA version: 12.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseAlzheimer's Disease
EUCTR2009-012456-25-DEPfizer Inc, 235 East 42nd Street, New York, NY 10017576