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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01445678
First received: September 26, 2011
Last updated: October 18, 2013
Last verified: October 2013

September 26, 2011
October 18, 2013
December 2011
October 2013   (final data collection date for primary outcome measure)
The proportion of subjects with clinical outcome of cure [ Time Frame: 26-30 days after start of study drug administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01445678 on ClinicalTrials.gov Archive Site
  • The proportion of subjects with microbiological outcome of success [ Time Frame: 26-30 days after start of study drug administration ] [ Designated as safety issue: No ]
  • 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-up [ Time Frame: 4-45 days after start of study drug administration ] [ Designated as safety issue: No ]
  • Safety will be evaluated in the safety population by presenting summaries of adverse events, clinical laboratory tests, vital signs, and physical examinations [ Time Frame: All study visits through the Late Follow Up (38-45 Days after completion of study drug administration) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections
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

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Complicated Intra-abdominal Infection
  • 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
  • Experimental: CXA-201 and Metronidazole as treatment for cIAI
    Intervention: Drug: CXA-201 and metronidazole
  • Active Comparator: Meropenem as treatment for cIAI
    Intervention: Drug: Meropenem
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
494
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Bulgaria,   Chile,   Croatia,   Estonia,   Germany,   Hungary,   Israel,   Korea, Republic of,   Latvia,   Lithuania,   Moldova, Republic of,   Poland,   Serbia
 
NCT01445678
CXA-cIAI-10-09
No
Cubist Pharmaceuticals
Cubist Pharmaceuticals
Not Provided
Study Director: Ellie Hershberger, Pharm.D Cubist Pharmaceuticals
Cubist Pharmaceuticals
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP