Health Condition 1: null- Complicated Intra-abdominal Infection
Conditions
Interventions
Intervention1: Drug: CXA-201 and metronidazole
: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days.
Control Intervention1: Drug: Meropenem: Meropenem IV infusio
Sponsors
Cubist Pharmaceuticals Inc
Pharmaceutical Research Associates India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnoses of cIAI. 2.Subject requires surgical intervention (e.g., laparotomy, laparoscopic surgery, or percutaneous draining of an abscess) within 24 hours of (before or after) the first dose of study drug.
Exclusion criteria
Exclusion criteria: 1.Simple appendicitis; acute suppurative cholangitis; infected necrotizing pancreatitis; pancreatic abscess; or pelvic infections. 2.Complicated intraabdominal infection managed by staged abdominal repair (STAR), open abdomen technique including temporary closure of the abdomen, or any situation where infection source control is not likely to be achieved. 3.Use of systemic antibiotic therapy for IAI for more than 24 hours prior to the first dose of study drug, unless there is a documented treatment failure with such therapy. 4.Have a concomitant infection at the time of randomization, which requires non-study systemic antibacterial therapy in addition to IV study drug therapy. (Drugs with only gram-positive activity [e.g., daptomycin, vancomycin, linezolid] are allowed). 5.Severe impairment of renal function (estimated CrCl 30 mL/min), or requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria ( 20 mL/h urine output over 24 hours). 6.The presence of hepatic disease at baseline. 7.Considered unlikely to survive the 4 to 5 week study period. 8.Any rapidly-progressing disease or immediately life-threatening illness (including respiratory failure and septic shock). 9.Have a documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibacterial (a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment), including cephalosporins, carbapenems, penicillins, or �-lactamase inhibitors, or metronidazole, or nitroimidazole derivatives. 10.Women who are pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with clinical outcome of cureTimepoint: 26-30 days after start of study drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be evaluated in the safety population by presenting summaries of adverse events, clinical laboratory tests, vital signs, and physical examinationsTimepoint: Time Frame: All study visits through the Late Follow Up (38-45 Days after completion of study drug administration;The proportion of subjects with clinical outcome of cure, failure, or indeterminate and microbiological outcome of success at the end of therapy and late follow-upTimepoint: Time Frame: 4-45 days after start of study drug administration;The proportion of subjects with microbiological outcome of successTimepoint: Time Frame: 26-30 days after start of study drug administration | — |
Countries
Argentina, Bulgaria, Canada, Croatia, Czech Republic, Germany, Hungary, India, Poland, Serbia, United States of America
Contacts
Public ContactMr Tarun Pandotra
PRA International
Outcome results
None listed