A Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Efficacy and Safety of Intravenous CXA-201 With That of Meropenem in Complicated Intraabdominal Infections

CompletadoFase 3ClinicalTrials.gov

ID: NCT01445678Tipo: INTERVENTIONALInicio: 23 de dic de 2011Fin estimado: 15 de oct de 2013

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Resumen

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).

Descripción detallada

Approximately, 500 subjects will be enrolled into this study, randomized 1:1 to receive CXA-201 and metronidazole or comparator (meropenem). Subject participation will require a minimum commitment of 38 days and a maximum of 45 days. An End of Treatment (EOT) visit will occur within 24 hours following the last dose of study drug administration/drug discontinuation. A Test of Cure (TOC)/Safety visit will be conducted 26 to 30 days following the first dose of study drug administration. A Last Follow-up (LFU) visit will be conducted 38 to 45 days after the first dose of study drug.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.
Diagnoses of cIAI.

Criterios de exclusión

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.

Intervenciones

drug

CXA-201 and metronidazole

CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days

drug

Meropenem

Meropenem IV infusion (1000mg q8h) for 4-14 days

Ubicaciones

Ciudadelo-Buenos Aires, Buenos Aires, Argentina

General Rodríguez, Buenos Aires, Argentina

La Plata, Buenos Aires, Argentina

Loma Hermosa, Buenos Aires, Argentina

Luján, Buenos Aires, Argentina

Merlo, Buenos Aires, Argentina

Tandil, Buenos Aires, Argentina

Vicente López, Buenos Aires, Argentina

Paraná, Entre Ríos Province, Argentina

Corrientes, Argentina

Córdoba, Argentina

Santa Fe, Argentina

Patrocinadores

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

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