Complicated intra-abdominal infection (cIAI) MedDRA version: 20.1 Level: LLT Classification code 10056570 Term: Intra-abdominal infection System Organ Class: 100000004862
Conditions
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 10 mg/dL OR =2 × ULN) 11. Has a seizure disorder or is anticipated to be treated with divalproex sodium or valproic acid during the course of study treatment 12. Is receiving, or is expected to receive, any of the following medications: a) Immunosuppressive agents b) Probenecid c) Valproic acid or divalproex sodium d) Disulfiram e) Ergot derivatives f) Ethanol-containing medications g) Nonstudy systemic (IV or oral) antibacterial treatments 13. Has any rapidly progressing disease or immediately life-threatening illness, including a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of ceftolozane/tazobactam plus metronidazole compared with that of meropenem;Secondary Objective: 1. To evaluate the efficacy of ceftolozane/tazobactam plus metronidazole compared with that of meropenem with respect to clinical response at the EOT and TOC Visits 2. To evaluate the efficacy of ceftolozane/tazobactam plus metronidazole compared with that of meropenem with respect to per-subject microbiological response at the EOT and TOC Visits ;Primary end point(s): 1. Adverse events (AEs) 2. Clinical laboratory tests 3. Vital signs;Timepoint(s) of evaluation of this end point: Safety evaluation all study visits | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: End of IV treatment (EOIV), End of treatment (EOT), Test of cure (TOC);Secondary end point(s): 1. Clinical success at the End of Treatment (EOT) and Test of Cure (TOC) Visits 2. Per-subject microbiological eradication at the EOT and TOC Visits | — |
Countries
Brazil, Hungary, Lithuania, Malaysia, Mexico, Romania, Russian Federation, South Africa, Spain, Turkey, Ukraine, United States
Contacts
Public ContactClinical Trial Operations Depart.
UAB Merck Sharp & Dohme
Outcome results
None listed