EUCTR2014-000546-30-ES进行中（未招募）1 期
A PHASE 3, MULTI-CENTER, RANDOMIZED, OPEN-LABEL STUDY OF CARBAVANCE (MEROPENEM/RPX7009) VERSUS BEST AVAILABLE THERAPY IN SUBJECTS WITH SELECTED SERIOUS INFECTIONS DUE TO CARBAPENEM RESISTANT ENTEROBACTERIACEAE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •11.Willingness to comply with all study activities and procedures and to
- •provide signed, written informed consent prior to any study procedures.
- •If a subject is unable to provide informed consent due to their medical
- •condition, the subject's legal representative will be provided with study
- •information in order for consent to be obtained.
- •2.Hospitalized male or female, >18 years of age.
- •3.Weight >150 kg.
- •4.Have a confirmed diagnosis of a serious infection, specifically cUTI or AP, HABP, VABP, and/or bacteremia, requiring administration of IV antibacterial therapy (See inclusion number 7 for criteria for all
- •indications).
- •5.The following must be satisfied:
- •For known CRE infection:
- •-Have a known CRE infection based on evidence from CRE culture or
- •other phenotypic or molecular testing within 72 hours prior to Day 1,
- •alone or as a single isolate of a polymicrobial infection;
- •-Have received no more than 24 hours of a potentially effective (i.e.,
- •gram negative coverage) antimicrobial therapy prior to enrollment,
- •-Have documented clinical evidence of failure (i.e., clinical deterioration
- •or failure to improve) while on a potentially effective regimen.
- •For suspected CRE infection:
- •-Have a suspected CRE infection based on evidence from CRE culture
- •(KPC producing) or other phenotypic or molecular testing, alone or as a
- •single isolate of a polymicrobial infection, from any source within 90
- •days prior to Day 1;
- •-Have received no more than 24 hours of a potentially effective (i.e.,
- •gram negative coverage) antimicrobial therapy prior to enrollment,
- •-Have documented clinical evidence of failure (i.e., clinical deterioration
- •or failure to improve) while on a potentially effective regimen.
- •6.Expectation, in the opinion of the Investigator, that the subject's
- •infection will require treatment with IV antibiotics for a minimum of 7
- •7.Diagnosis with either cUTI or AP, HABP, VABP, and/or bacteremia as
- •defined per protocol.
- •8.Female subjects of child-bearing potential, including those who are
- •less than 2 years post-menopausal, must agree to, and comply with,
- •using 2 highly effective methods of birth control (i.e., condom plus
- •spermicide, combined oral contraceptive, implant, injectable, indwelling
- •intrauterine device, sexual abstinence, or a vasectomized partner) while
- •participating in this study. In addition, all women of childbearing
- •potential must agree to continue to use 2 forms of birth control
- •throughout the study and for at least 30 days after administration of the
- •last dose of study drug.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1.History of any significant hypersensitivity or severe allergic reaction to any beta lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems, or monobactams).
- •2.Known or suspected likely infection with New Delhi metallo- (NDM), Verona integron encoded metallo- (VIM), or IMP-metallo-beta-lactamases or oxacillinase- (OXA) beta lactamases (i.e., Class B or Class D beta lactamases).
- •3.For subjects to be enrolled with the primary indication of cUTI or AP, any of the following urologic conditions:
- •Likely to receive ongoing antibacterial drug prophylaxis after treatment of cUTI (e.g., subjects with vesico-ureteral reflux);
- •Suspected or confirmed prostatitis;
- •Requirement for bladder irrigation with antibiotics or for antibiotics to be administered directly via urinary catheter;
- •Previous or planned cystectomy or ileal loop surgery;
- •Uncomplicated urinary tract infection (for example, female subjects with urinary frequency, urgency or pain or discomfort without systemic symptoms or signs of infection);
- •Complete, permanent obstruction of the urinary tract;
- •Suspected or confirmed perinephric or renal corticomedullary abscess; or Polycystic kidney disease.
- •4.For subjects to be enrolled with the primary indication of HABP or VABP, any of the following conditions:
- •Diagnosis of ventilator-associated tracheobronchitis
- •Inability to obtain proper respiratory specimens for culture
- •5.For subjects to be enrolled with the indication of bacteremia unrelated to cUTI or AP, HABP, and VABP, any of the following:
- •Unverified CRE infection
- •Source of infection thought to be related to or involving a non removable or implantable device or line.
- •6.Impairment of renal function including a calculated creatinine clearance of <20 mL/min (Cockcroft-Gault), requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (<20 mL urine output per hour over 24 hours).
- •7.Evidence of immediately life-threatening disease, including, but not limited to, acute heart failure, shock, acute coronary syndrome, unstable arrhythmias, hypertensive emergency, acute hepatic failure, active gastrointestinal bleeding, profound metabolic abnormalities (e.g., diabetic ketoacidosis), or acute cerebrovascular events, OR in the opinion of the Investigator, the subject is unlikely to survive the duration of the treatment.
- •8.Myasthenia gravis, Parkinsonism, or other neuromuscular disorder.
- •9.Acute Physiology and Chronic Health Evaluation (APACHE) II score >30. An APACHE II score is only required if calculated.
- •10.Known or suspected endocarditis, meningitis, intra-abdominal infection, or osteomyelitis.
- •11.Unremovable or implantable device or line thought to be the potential source of infection.
- •12.Evidence of significant hepatic, hematological, or immunologic disease or dysfunction determined by any of the following:
- •Known acute viral hepatitis;
- •Aspartate aminotransferase or alanine aminotransferase level >5 × upper limit of normal (ULN) or total bilirubin >3 × ULN;
- •Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy;
- •Current or anticipated neutropenia defined as <500 neutrophils/mm3;
- •Thrombocytopenia with platelet count <60,000 cells/mm3;
- •Human immunodeficiency virus with either a CD4 count <200 cells/mm3 at the last measurement, or current diagnosis of another Acquired Immune Deficiency Syndrome-defining illness;
- •Bone marrow-ablative chemotherapy or radiation therapy within the prior 3 months; or Requiring chronic treatmen
研究者
相似试验
进行中（未招募）
1 期
A randomized open-lable 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 best available therapy to treat patients with selected serious urinary infections, bacterial pneumonia infections and/or blood infections known or suspected to be caused by carbapenem-resistant Enterobacteriaceae.serious infections, specifically complicated urinary tract infection (cUTI) or acute pyelonephritis (AP), hospital acquired bacterial pneumonia (HABP), ventilator associated bacterial pneumonia (VABP), and/or bacteremia, known or suspected to be caused by carbapenem-resistant Enterobacteriaceae (CRE)MedDRA version: 17.1Level: LLTClassification code 10003999Term: BacteremiaSystem Organ Class: 100000004862MedDRA version: 17.1Level: LLTClassification code 10001032Term: Acute pyelonephritisSystem Organ Class: 100000004862MedDRA version: 17.1Level: LLTClassification code 10004051Term: Bacterial pneumonia, unspecifiedSystem Organ Class: 100000004862MedDRA version: 17.1Level: HLTClassification code 10046577Term: Urinary tract infectionsSystem Organ Class: 100000004862EUCTR2014-000546-30-ITRempex Pharmaceuticals, Inc.150
进行中（未招募）
1 期
A randomized open-lable 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 best available therapy to treat patients with selected serious urinary infections, bacterial pneumonia infections and/or blood infections known or suspected to be caused by carbapenem-resistant Enterobacteriaceae.EUCTR2014-000546-30-GRRempex Pharmaceuticals, Inc.150
进行中（未招募）
1 期
A randomized open-lable 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 best available therapy to treat patients with selected serious urinary infections, bacterial pneumonia infections and/or blood infections known or suspected to be caused by carbapenem-resistant Enterobacteriaceae.serious infections, specifically complicated urinary tract infection (cUTI) or acute pyelonephritis (AP), complicated intra-abdominal infections (cIAI), hospital acquired bacterial pneumonia (HABP), ventilator associated bacterial pneumonia (VABP), and/or bacteremia, known or suspected to be caused by carbapenem-resistant Enterobacteriaceae (CRE)MedDRA version: 18.0 Level: LLT Classification code 10003999 Term: Bacteremia System Organ Class: 100000004862MedDRA version: 18.0 Level: LLT Classification code 10001032 Term: Acute pyelonephritis System Organ Class: 100000004862MedDRA version: 18.0 Level: LLT Classification code 10056570 Term: Intra-abdominal infection System Organ Class: 100000004862MedDRA version: 18.0 Level: LLT Classification code 10004051 Term: Bacterial pneumonia, unspecified System Organ Class: 100000004862MedDRA version: 18.0 Level: HLT Classification code 10046577 Term: Urinary tract infections System Organ Class: 100000004862EUCTR2014-000546-30-GBRempex Pharmaceuticals, Inc.150
进行中（未招募）
不适用
A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL, STUDY OF AZACITIDINE (VIDAZA) VERSUS CONVENTIONAL CARE REGIMENS FOR THE TREATMENT OF OLDER SUBJECTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA - NDEUCTR2009-012346-23-ITCelgene Corporation480
进行中（未招募）
1 期
A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL, STUDY OF AZACITIDINE(VIDAZA®) VERSUS CONVENTIONAL CARE REGIMENS FOR THE TREATMENT OF OLDERSUBJECTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIAewly diagnosed de novo Acute Myeloid Leukemia (AML) or AML secondary to prior myelodysplastic disease in older subjects with >30% bone marrow blasts and who are not eligible for hematopoietic stem cell transplantation.MedDRA version: 12.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaEUCTR2009-012346-23-FRCelgene Corporation480