EUCTR2017-003773-34-LV进行中（未招募）1 期
A prospective Phase 3, double-blind, multicenter, randomized study of the efficacy and safety of sulopenem followed by sulopenem etzadroxil with probenecid versus ertapenem followed by ciprofloxacin and metronidazole or amoxicillin-clavulanate for treatment of complicated intra-abdominal infections in adults. - IT001-303
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
- 670
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
入选标准
- •1. Patient able to provide a signed written informed consent prior to any study-specific procedures.
- •2. Adult patients =18 years of age
- •3. EITHER:
- •a. Intra-operative/post-operative enrollment with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis including at least 1 of the following diagnosed during the surgical intervention:
- •i. Cholecystitis with gangrenous rupture or perforation or progression of the infection beyond the gallbladder wall
- •ii. Diverticular disease with perforation or abscess
- •iii. Appendiceal perforation or peri-appendiceal abscess
- •iv. Traumatic perforation of the intestines, only if operated on >12 hours after perforation occurs
- •v. Secondary peritonitis (but not spontaneous bacterial peritonitis associated with cirrhosis and chronic ascites)
- •vi. Intra-abdominal abscess (including of liver or spleen provided that there was extension beyond the organ with evidence of intraperitoneal involvement).
- •b. Pre-operative enrollment where one of the following surgical procedures are planned within 24 hours of the first dose of study drug:
- •i. Open laparotomy, percutaneous drainage of an intra-abdominal abscess, or laparoscopic surgery.
- •4. Evidence of systemic inflammatory indicators, with at least one of the following:
- •a. Fever (defined as body temperature >38°C) or hypothermia with a core body temperature <35°C
- •b. Elevated white blood cell count (>12,000 cells/mm3) or leukopenia (defined as white blood cell count <4,000 cells/mm3)
- •c. Drop in blood pressure (systolic BP must be <90 mmHg without pressor support)
- •d. Increased heart rate (>90 bpm) and respiratory rate (>20 breaths/min)
- •e. Hypoxia (oxygen saturation =90 percent on room air)
- •5. Physical findings or symptoms consistent with intra-abdominal infection, with at least one of the following:
- •a. Abdominal pain and/or tenderness, with or without rebound
- •b. Localized or diffuse abdominal wall rigidity
- •c. Abdominal mass
- •d. Nausea and/or vomiting
- •e. Altered Mental Status
- •6. Specimen/s from the surgical intervention were sent or planned to be sent for culture.
- •Microbiologic specimens collected during routine operative care prior to subject providing informed consent may be used for study purposes.
- •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 469
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 201
排除标准
- •1. Patient diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal processes in which the primary etiology was not likely to be infectious.
- •2. Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation.
- •3. Patient has simple cholecystitis or gangrenous cholecystitis without rupture, or simple appendicitis, or acute suppurative cholangitis; or infected necrotizing pancreatitis or pancreatic abscess.
- •4. Patient whose surgery included staged abdominal repair, or open abdomen” technique, or marsupialization.
- •5. Patient known at study entry to have a complicated intra-abdominal infection caused by pathogens non-susceptible to the study antimicrobial agents.
- •6. Patient needed effective concomitant systemic antibacterials or antifungals in addition to those designated in the 2 study groups, except vancomycin, linezolid, or daptomycin if started for known or suspected MRSA or Enterococcus spp.
- •7. Patient has perinephric infections or an indwelling peritoneal dialysis catheter.
- •8. Patient has suspected intra-abdominal infections due to fungus, parasites, virus, or tuberculosis.
- •9. Patient with known history of serious allergy, hypersensitivity or any serious reaction to carbapenem antibiotics, other ß-lactam antibiotics, quinolones, metronidazole, or probenecid, as formulated with their excipients.
- •10. Patient known to have any of the following laboratory values as defined below:
- •a. Hematocrit <25% or hemoglobin <8 g/dL
- •b. Absolute neutrophil count <1000/mm3
- •c. Platelet count <75,000/mm3
- •d. Bilirubin >3 x the ULN, unless isolated hyperbilirubinemia was directly related to the acute infection or known Gilbert’s disease
- •e. ALT or AST >3 x ULN values at Screening. Patients with elevations of AST and/or ALT up to 5 x ULN will be eligible if these elevations are acute and directly related to the infectious process being treated. This must be documented
- •f. ALP >3 x ULN. Patients with values >3.0 x ULN and <5.0 x ULN are eligible if this value is acute and directly related to the infectious process being treated. This must be documented.
- •11. Patient has a body mass index >45 kg/m2.
- •12. Patient has APACHE II score >30 (serum bicarbonate may be used in place of arterial blood gases).
- •13. Patient considered unlikely to survive the 4-week study period or has a rapidly progressive or terminal illness, including septic shock that was associated with a high risk of mortality.
- •14. Patient unlikely to respond to 10–14 days of treatment with antibiotics.
- •15. Patient received systemic antibacterial agents within the 72-hour period prior to study entry, unless either of the following pertained:
- •a. Patient has new infection (not considered a treatment failure) and both of the following were met:
- •i. Patient received no more than 24 hours of total prior antibiotic therapy
- •ii. Patient received =1 dose of a treatment regimen post-operatively and antibiotics were not received more than 6 hours post-procedure.
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