Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections

Completed · Phase 3

Conditions studied: Complicated Intra-abdominal Infection

In brief

This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA-201 Intravenous (IV) infusions (1500mg q8h) and metronidazole (500mg q8h) versus meropenem (1000mg q8h)for the treatment of adults with Complicated Intraabdominal Infections (cIAI).

Key facts

Study ID

NCT01445678

Run by

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

494

Starts

2011-12-23

Expected to finish

2013-10-15

Last updated by the study team

2018-11-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnoses of cIAI.
• 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.

You may not qualify if…

• Simple appendicitis; acute suppurative cholangitis; infected necrotizing pancreatitis; pancreatic abscess; or pelvic infections.
• 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.
• 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.
• 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).
• 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).
• The presence of hepatic disease at baseline.
• Considered unlikely to survive the 4 to 5 week study period.
• Any rapidly-progressing disease or immediately life-threatening illness (including respiratory failure and septic shock).
• 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 ß-lactamase inhibitors, or metronidazole, or nitroimidazole derivatives.
• Women who are pregnant or nursing.

Where it is running

• Study site — Boston, Massachusetts, United States
• Study site — Robbinsdale, Minnesota, United States
• Study site — Columbus, Ohio, United States
• Study site — Ciudadelo-Buenos Aires, Buenos Aires, Argentina
• Study site — General Rodriguez, Buenos Aires, Argentina
• Study site — La Plata, Buenos Aires, Argentina
• Study site — Loma Hermosa, Buenos Aires, Argentina
• Study site — Luján, Buenos Aires, Argentina
• Study site — Merlo, Buenos Aires, Argentina
• Study site — Tandil, Buenos Aires, Argentina
• Study site — Vicente López, Buenos Aires, Argentina
• Study site — Paraná, Entre Ríos Province, Argentina
• Study site — Corrientes, Argentina
• Study site — Córdoba, Argentina
• Study site — Santa Fe, Argentina
• Study site — Pleven, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Varna, Bulgaria
• Study site — Temuco, Cautin, Chile
• Study site — Santiago, Chile
• Study site — Split, Dalmatia, Croatia
• Study site — Zagreb, Croatia
• Study site — Kohtla-Järve, Estonia
• Study site — Tallinn, Estonia
• Study site — Springfield, Illinois, United States

Full record on ClinicalTrials.gov

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