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
  Purpose

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).


Condition Intervention Phase
Complicated Intra-abdominal Infection
Drug: CXA-201 and metronidazole
Drug: Meropenem
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 494
Study Start Date: December 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CXA-201 and Metronidazole as treatment for cIAI Drug: CXA-201 and metronidazole
CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
Active Comparator: Meropenem as treatment for cIAI Drug: Meropenem
Meropenem IV infusion (1000mg q8h) for 4-14 days

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445678

  Show 61 Study Locations
Sponsors and Collaborators
Cubist Pharmaceuticals
Investigators
Study Director: Ellie Hershberger, Pharm.D Cubist Pharmaceuticals
  More Information

No publications provided

Responsible Party: Cubist Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01445678     History of Changes
Other Study ID Numbers: CXA-cIAI-10-09
Study First Received: September 26, 2011
Last Updated: October 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:
cIAI

Additional relevant MeSH terms:
Infection
Communicable Diseases
Intraabdominal Infections
Meropenem
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on September 16, 2014