EUCTR2010-022548-19-BG进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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.Subjects must meet all of the following criteria:
- •1. Abdominal pain/discomfort with onset prior to hospitalization.
- •2. Evidence of a systemic inflammatory response with at least one of the following:
- •a. Fever (oral temperature > 100.4°F / 38°C) or hypothermia (oral temperature <
- •35°C / 95°F)
- •b. Elevated WBC ( > 10,500/mm3)
- •c. Tachycardia (Heart rate > 90 beats/min)
- •d. Tachypnea ( > 20 breaths/min)
- •3. 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)
- •4. 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
- •5. At least 18 years and no older than 75 years of age
- •6. Body mass index (BMI) of = 30 kg/m2
- •7. 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
- •8. 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
- •9A. Meets Inclusion Criteria for Pre-operative Enrollment:
- •? Has a sonogram or radiographic imaging result congruent with the diagnosis of cIAI
- •? Acute surgical or percutaneous intervention (open laparotomy, laparoscopic surgery, or percutaneous drainage of an abscess) is foreseen
- •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
- •? Clinical diagnoses consistent with one or more of the following:
- •1. Appendiceal perforation and periappendiceal abscess
- •2. Diverticular abscess
- •3. Acute gastric or duodenal perforation (only if operated on > 24 hrs after
- •perforation occurs)
- •4. Traumatic perforation of the intestines (only if operated on > 12 hrs after
- •perforation occurs)
- •5. Abscess or peritonitis due to other perforated viscus, or other gastrointestinal
- •9B. Meets Inclusion Criteria for Intra-operative/Post-operative Enrollment:
- •? Visual confirmation (presence of pus within the abdominal cavity)
- •? Samples taken for aerobic and anaerobic culture should be taken by aspiration or tissue sample and immediately inoculated to appropriate media
- •? Surgical intervention includes open laparotomy, laparoscopic surgery, or percutaneous draining of an abscess
- •? Initial intervention is adequate, i.e. 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
- •? Intra-operative diagnoses include one or more of the following:
- •1. Appendiceal perforation and periappendiceal abscess
- •2. Diverticular abscess
- •3. Acute gastric and duodenal perforations (only if operated on > 24 hrs after
- •perforation occurs)
- •4. Traumatic perforation of the intestines (only if operated on > 12 hrs after
- •perforation occurs)
- •5. Abscess or peritonitis due to perforated viscus, or other focus of infection (but
排除标准
- •1. Symptoms related to diagnosis of complicated appendicitis (if current diagnosis) for < 24 hrs prior to current hospitalization
- •2. Previously hospitalized or admitted to a healthcare facility (includes 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 > 25
- •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 (i.e., dopamine greater than 5
- •µg/kg/min, any dose of norepinephrine, epinephrine or phenylephrine) to maintain a systolic blood pressure > 90 mm Hg or a mean arterial pressure > 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 > 75% to a known previous value
- •c. Urine output of < 0.3 mL/kg per h for > 24 h or
- •d. Anuria for > 12 h or
- •e. Serum creatinine of > 4 mg/dL (353.6 µmol/L) with an acute rise of 0.5 mg/dL
- •(42.2 µmol/L) compared with a previous value
- •10. Creatinine clearance < 30 mL/min as estimated by the Cockcroft-Gault equation = (140- age[years]) * (Body Weight [kg]) * (0.85 if female) / (72 * Serum Creatinine [mg/dL]); or requires peritoneal dialysis, hemodialysis, or hemofiltration
- •11. Presence or possible signs of hepatic disease:
- •a. Alanine aminotransferase or aspartate aminotransferase > 3 x upper limit of
- •normal (ULN) or
- •b. Total bilirubin > 3 x ULN, unless isolated hyperbilirubinemia is directly related
- •to the acute process or
- •c. Alkaline phosphatase > 3 x ULN or
- •d. Subjects with diagnosis of hepatic failure
- •12. Hematocrit < 25% or hemoglobin < 8 g/dL
- •13. Neutropenia with absolute neutrophil count < 1000/mm3
- •14. Platelet count < 50,000/mm3
- •15. Coagulation tests > 1.5 x ULN (i.e., prothrombin time, partial thromboplastin time, or international normalized ratio)
- •16. Patient on anticoagulants prior to hospital admission, except 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 (e.g., > 40 mg prednisone or equivalent per day for greater than 2 weeks)
- •18. History of moderate or severe hypersensitivity reactions to tetracyclines or carbapenems or ß-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 (e.g., severe cerebral arteriosclerosis, epilepsy)
- •21. Previously received TP-434 in a clinical trial
- •22. Antibiotic-related exclusions:
- •a. More than 24 hrs duration of systemic antibiotic coverage for current condition
- •(24 hrs duration defined by recommended dosing interval in the respective
- •prescribing information)
- •b. Received ertapenem or any other carbapenem, or tigecycline for the current
- •c. Need for concomitant systemic antimicrobial agents other than study drug
- •(including female subjects with clinical diagnosis of pelvic inflammatory
- •d. Known to have rece
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