CTRI/2011/10/002076招募中2 期
A Phase 2, Randomized, Double-Blind, Double-Dummy, Multicenter,Prospective Study to Assess the Efficacy, Safety and Pharmacokinetics of 2Dose Regimens of TP-434 Compared with Ertapenem in Adult Community-Acquired Complicated Intra-abdominal Infections
Tetraphase Pharmaceuticals Inc11 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年10月28日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 11
- 主要终点
- Compare clinical response at the test-of-cure (TOC) visit in the microbiologically evaluable (ME) population for
研究概览
简要总结
The proposed clinical trial is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of 2 dose regiments of TP‑434 (1.5 mg/kg every 24 hours [q24h], or 1.0 mg/kg every 12 hours [q12h]) compared with Ertapenem (1g q24h) in adult community-acquired complicated intra-abdominal infections. Randomization to the TP-434 (1.5 mg/kg q24h), TP-434 (1.0 mg/kg q12h), or ertapenem (1g q24h) treatment arms will occur in a 2:2:1 ratio. TP-434 is a novel antibiotic of the tetracycline class. The in vitro and in vivo potency and spectrum of TP-434 makes it an excellent candidate as a new single therapy treatment option for serious nosocomial infections, including skin, respiratory, urinary tract, and intra-abdominal infections.Bulgaria, India, Lithuania, Romania, and USA are the participating countries.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Abdominal pain or discomfort with onset prior to hospitalization
- •Evidence of a systemic inflammatory response with at least one of the following a.
- •Fever (oral temperature greater than 100.4 degree Fahrenheit or 38 degree Celsius) or hypothermia (oral temperature less than 35 degree Celsius/95 degree Fahrenheit).
- •Elevated white blood cell (WBC) count (greater than 10,500 per cubic mm) c.
- •Tachycardia (Heart rate greater 90 beats per min) d.
- •Tachypnea (greater than 20 breaths per min)
- •Physical findings consistent with intra-abdominal infection (IAI, defined as localized or diffuse abdominal tenderness (Other supportive findings include presence of a mass, ileus, or rebound tenderness)
- •Clinical diagnosis of community-acquired intra-abdominal infection requiring urgent surgical or percutaneous intervention and not expected to require antibacterial therapy for longer than 14 days
- •At least 18 years and no older than 75 years of age
- •Able to provide informed consent.
- •If the patient is unable to provide informed consent, the patient’s legally acceptable representative may provide written consent in accordance with institutional guidelines If female: a.
- •Not pregnant or nursing b.
- •If of child-bearing potential will commit to either: i.
- •use at least two medically accepted, effective methods of birth control (e.g., condom, oral contraceptive, indwelling intrauterine device, hormonal implant/patch, injections, approved cervical ring) during study drug dosing and for 90 days following last study drug dose ii.
- •Sexual abstinence And either 9A.
- •Meets Inclusion Criteria for Pre-operative Enrollment a) Has a sonogram or radiographic imaging result congruent with the diagnosis of cIAI b) Acute surgical or percutaneous intervention (open laparotomy, laparoscopic surgery, or percutaneous drainage of an abscess) is foreseen c) Specimens from the surgical intervention representative of the material associated with infection will be collected by aspiration or tissue sample and sent for culture and susceptibility testing d) Clinical diagnoses consistent with one or more of the following
- •Diverticular abscess
- •Acute gastric or duodenal perforation (only if operated on greater than 24 hrs after perforation occurs)
- •Traumatic perforation of the intestines (only if operated on greater than 12 hrs after perforation occurs)
- •Abscess or peritonitis due to other perforated viscus, or other gastrointestinal source or 9B.
- •Meets Inclusion Criteria for Intra-operative or Post-operative Enrollment a) Visual confirmation (presence of pus within the abdominal cavity) b)Samples taken for aerobic and anaerobic cultures should be taken by aspiration or tissue sample and immediately inoculated to appropriate media c)Surgical intervention includes open laparotomy, laparoscopic surgery, or percutaneous draining of an abscess d)Initial intervention is adequate, that is a procedure in which all communications between the GI tract and the peritoneal cavity are closed, no necrotic intestine is left, and all infected collections are drained at the initial procedure e)Intra-operative diagnoses include one or more of the following 1.Appendiceal perforation and periappendiceal abscess
- •Abscess or peritonitis due to perforated viscus, or other focus of infection (but not spontaneous bacterial peritonitis associated with cirrhosis and chronic ascites)
- •Other intra-abdominal abscess (excluding liver and spleen) from a gastrointestinal source.
排除标准
- •Subjects must NOT meet any of the following exclusion criteria 1 Symptoms related to diagnosis of complicated appendicitis (if current diagnosis) for less than 24 hrs prior to current hospitalization 2 Previously hospitalized or admitted to a healthcare facility (including nursing or convalescent home) within the last 6 months 3 Managed by Staged Abdominal Repair or other open abdomen technique 4 Known at study entry to have an IAI caused by a pathogen(s) resistant to one of the study drug antibiotics 5 Acute Physiology and Chronic Health Evaluation (APACHE) II score grater than25 6 Considered unlikely to survive the 6-8 week study period 7 Any rapidly-progressing disease or immediately life-threatening illness, including acute hepatic failure, respiratory failure and septic shock 8 Requirement for vasopressors at therapeutic dosages (ie dopamine greater than 5 μgperkgpermin, any dose of norepinephrine, epinephrine or phenylephrine) to maintain a systolic blood pressure greater than or equal to90 mm Hg or a mean arterial pressure greater than or equal to 70 mm Hg 9 Renal failure as defined as a Threefold increase of serum creatinine to a known previous value or b Decrease in estimated glomerular filtration rate greater than 75 percent to a known previous value or c Urine output of less than 0.3 mL per kg per h for greater than 24 h or d Anuria for greater than 12 h or e Serum creatinine of greater than 4 mg per dL (353.6 μmol per L) with an acute rise of 0.5 mg per dL (42.2 μ mol per L) compared with a previous value 10 Creatinine clearance less than 30 mLpermin as estimated by the Cockcroft-Gault equation (140-age[years]) (Body Weight in kg) (0.85 if female) per (72 Serum Creatinine [mg per dL]); or requires peritoneal dialysis, hemodialysis, or hemofiltration 11 Presence or possible signs of hepatic disease: a Alanine aminotransferase or aspartate aminotransferase greater than 3 x upper limit of normal (ULN) or b Total bilirubin greater than 3 x ULN unless isolated hyperbilirubinemia is directly related to the acute process or c Alkaline phosphatase greater than 3 x ULN or d Subjects with diagnosis of hepatic failure 12 Hematocrit less than 25 percent or hemoglobin less than 8 g per dL 13 Neutropenia with absolute neutrophil count less than 1000 per cubic mm 14 Platelet count less than 50000 per cubic mm 15 Coagulation tests greater than 1.5 x ULN (that is prothrombin time partial thromboplastin time, or international normalized ratio) 16 Patient on anticoagulants prior to hospitalization (excluding low dose aspirin therapy) 17 Immunocompromised condition, including known HIV positivity or AIDS organ (bone marrow) transplant recipients, and hematological malignancy.
- •Immunosuppressive therapy, including use of high-dose corticosteroids (eg greater than 40 mg prednisone or equivalent per day for greater than 2 weeks) 18 History of moderate or severe hypersensitivity reactions to tetracyclines carbapenems or β-lactam antibiotics 19 Participation in any investigational drug or device study within 30 days prior to study entry 20 Known or suspected current central nervous system (CNS) disorder that may predispose to seizures or lower seizure threshold (eg severe cerebral arteriosclerosis epilepsy) 21 Previously received TP-434 in a clinical trial 22 Antibiotic-related exclusions aMore than 24 hours duration of systemic antibiotic coverage for current condition (24 hrs duration as defined by recommended dosing interval in the respective prescribing information) b Received ertapenem or any other carbapenem or tigecycline for the current infection c Need for concomitant systemic antimicrobial agents other than study drug (including female subjects with clinical diagnosis of pelvic inflammatory disease) d Known to have received systemic antibiotics (oral or IV) in the last 3 months (except for current acute condition or single dose such as for dental prophylaxis) 23 Refusal of mechanical ventilation, dialysis or hemofiltration, cardioversion or any other resuscitative measures and drugperfluid therapy at time of consent 24 Known or suspected inflammatory bowel disease or associated visceral abscess.
结局指标
主要结局
Compare clinical response at the test-of-cure (TOC) visit in the microbiologically evaluable (ME) population for
时间窗: primary endpoint of this study will be clinical response at the TOC visit that is 10-14 days after last dose of study drug
subjects in the 3 treatment arms
时间窗: primary endpoint of this study will be clinical response at the TOC visit that is 10-14 days after last dose of study drug
次要结局
- 1) Compare clinical response for subjects in the 3 treatment arms in the following populations(a) Modified intent-to-treat (MITT))
研究者
研究点 (11)
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