EUCTR2016-004820-41-LT进行中（未招募）1 期
A Phase 2, Randomized, Active Comparator-Controlled, Multicenter, Double-Blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem in Pediatric Subjects with Complicated Intra- Abdominal Infection - Ceftolozane/tazobactam (MK-7625A) plus Metronidazole vs Meropenem in pediatric cIAI
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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. Have a legally acceptable representative who provides documented informed consent/assent for the trial.
- •2. Be a male or female from birth (defined as >32 weeks gestational age and =7 days postnatal) to <18 years of age
- •3. Be able to comply with the protocol for the duration of the trial
- •4. Require IV antibacterial therapy for the treatment of presumed or documented cIAI as demonstrated by either:
- •Operative diagnosis (laparotomy, laparoscopy or percutaneous drainage) of cIAI, defined as evidence of infection within the abdominal cavity extending beyond the hollow viscus of origin into the peritoneal space as demonstrated by either abscess formation or peritonitis
- •Preoperative diagnosis of cIAI, defined as meeting both of the criteria below:
- •a) Clinical evidence of cIAI as indicated by one or more systemic signs or symptoms that accompany cIAI, such as fever, leukocytosis, hypotension, abdominal pain, nausea/vomiting, anorexia, abdominal mass on clinical examination, or altered mental status
- •b) Radiographic evidence consistent with cIAI.
- •5. Have an operative procedure for the current diagnosis and management of cIAI planned or completed within 24 hours of the first dose of an antibacterial drug
- •6. Have baseline intra-abdominal specimen collection in compliance with protocol Section 7.1.3.4 – Intra-abdominal Samples for Culture. Subjects enrolled preprocedure should have a sample obtained during the interventional procedure performed to comply with protocol Section 7.1.3.4
- •7. Meet one of the following categories:
- •a) The subject is a male who is not of reproductive potential, defined as a male who has azoospermia (whether due to being prepubertal, having had a vasectomy, or an underlying medical condition)
- •b) The subject is a female not of reproductive potential, defined as a female who either: (1) Has not undergone menarche, (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening, or (3) has a congenital or acquired condition that prevents childbearing
- •c) The subject is a female or a male of reproductive potential who agrees to avoid becoming pregnant or impregnating a partner during screening, while receiving study treatment and for at least 30 days after the last dose of study treatment by complying with one of the following: (1) Practice abstinence from heterosexual activity OR (2) use (or have their partner use) acceptable contraception during heterosexual activity
- •8. Meet the following criteria for a female subject who is of reproductive potential:
- •a) The subject is not pregnant (as confirmed by serum pregnancy test at screening) and not planning to become pregnant within 30 days of the last day of treatment administration,
- •b) The subject is nonlactating
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Is currently participating in or has participated in an interventional
- •clinical trial with an investigational compound or device within 30 days
- •prior to the first dose of study treatment in this current trial
- •2. Has previously participated in any trial of ceftolozane or
- •ceftolozane/tazobactam or has enrolled previously in the current trial
- •and been discontinued
- •3. Has a history or current evidence of any condition, therapy, laboratory
- •abnormality, or other circumstance that, in the opinion of the
- •investigator, might expose the subject to increased risk by participating
- •in the trial, confound the results of the trial, or interfere with the
- •subject's participation for the full duration of the trial
- •4. Has a history of any moderate or severe hypersensitivity (eg,
- •anaphylaxis), allergic reaction, or other contraindication to any of the
- •following: ß-lactam antibiotics (eg, penicillins, cephalosporins, and
- •carbapenems), ß-lactamase inhibitors (eg, tazobactam, sulbactam,
- •clavulanic acid, avibactam), or metronidazole.
- •5. Has an IAI within the past 1 year prior to randomization known to be
- •caused by a pathogen resistant to either IV study treatment
- •6. Has a concomitant infection at the time of randomization that requires
- •nonstudy systemic antibacterial therapy in addition to IV study
- •treatment or oral step-down therapy (medications with only grampositive
- •activity [eg, vancomycin, linezolid] are allowed)
- •7. Has received potentially therapeutic antibacterial therapy (eg, with
- •gram-negative activity) for a duration more than 24 hours during the 48
- •hours preceding the first dose of study treatment, unless the subject is
- •considered to be failing antibiotic therapy for cIAI
- •8. Has any of the following:
- •a) Intractable cIAI that the investigator anticipates would require more
- •than 14 days of study treatment
- •b) Abdominal wall abscess
- •c) Small bowel obstruction
- •d) Ischemic bowel disease without perforation
- •e) Traumatic bowel perforation with surgery within 12 hours of
- •perforation
- •f) Perforation of gastroduodenal ulcers requiring surgery within 24
- •hours of perforation (these are considered situations of peritoneal
- •soiling before the infection has become established)
- •g) Suspected uncomplicated intra-abdominal infection (eg, cholecystitis
- •without rupture or extension beyond the gallbladder wall)
- •h) Acute suppurative cholangitis
- •i) Infected necrotizing pancreatitis
- •j) Pancreatic abscess
- •9. Has moderate or severe impairment of renal function, defined as an
- •estimated creatinine clearance <50 mL/min/1.73 m2 based on the
- •revised Schwartz equation or requirement for peritoneal dialysis,
- •hemodialysis, or hemofiltration
- •10. Has one or more of the following laboratory abnormalities in a
- •specimen obtained at baseline:
- •a) Absolute neutrophil count <1000/mm3
- •b) Aspartate aminotransferase or alanine aminotransferase =3 × the
- 另有 16 项未显示
研究者
相似试验
进行中（未招募）
1 期
A Phase 2, controlled study to evaluate safety and efficacy of SelK2 in patients undergoing total knee replacement.Venous thromboembolism occurring in patients undergoing total knee replacement arthroplastyMedDRA version: 20.0Level: PTClassification code 10051055Term: Deep vein thrombosisSystem Organ Class: 10047065 - Vascular disordersEUCTR2018-003122-88-BGTetherex Pharmaceuticals Corporation285
进行中（未招募）
1 期
A Phase 2, controlled study to evaluate safety and efficacy of SelK2 in patients undergoing total knee replacement.Venous thromboembolism occurring in patients undergoing total knee replacement arthroplastyMedDRA version: 21.1Level: PTClassification code 10051055Term: Deep vein thrombosisSystem Organ Class: 10047065 - Vascular disordersEUCTR2018-003122-88-PLTetherex Pharmaceuticals Corporation285
进行中（未招募）
1 期
Ceftolozane/tazobactam (MK-7625A) versus Meropenem in Pediatric Complicated Urinary Tract InfectioEUCTR2016-004153-32-PLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.120
进行中（未招募）
1 期
Ceftolozane/tazobactam (MK-7625A) plus Metronidazole versus Meropenem in pediatric complicated intra-abdominal infectioComplicated intra-abdominal infection (cIAI)MedDRA version: 20.1Level: LLTClassification code 10056570Term: Intra-abdominal infectionSystem Organ Class: 100000004862EUCTR2016-004820-41-Outside-EU/EEAMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
进行中（未招募）
1 期
A Phase 2, controlled study to evaluate safety and efficacy of SelK2 in patients undergoing total knee replacement.Venous thromboembolism occurring in patients undergoing total knee replacement arthroplastyMedDRA version: 20.0 Level: PT Classification code 10051055 Term: Deep vein thrombosis System Organ Class: 10047065 - Vascular disordersEUCTR2018-003122-88-LVTetherex Pharmaceuticals Corporation285