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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01445678
Recruitment Status : Completed
First Posted : October 4, 2011
Results First Posted : January 15, 2015
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Complicated Intra-abdominal Infection Drug: CXA-201 and metronidazole Drug: Meropenem Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 494 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : December 23, 2011
Actual Primary Completion Date : October 3, 2013
Actual Study Completion Date : October 15, 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. The Percentage of Subjects With Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population [ Time Frame: TOC; 26-30 days after start of study drug administration ]
    Clinical cure is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.


Secondary Outcome Measures :
  1. The Percentage of Subjects With Microbiological Outcome of Success at the TOC Visit in the Microbiologically Evaluable (ME) Population [ Time Frame: TOC; 26-30 days after start of study drug administration ]
    Success is eradication (absence of the baseline pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a subject who was assessed as a clinical cure) for each baseline pathogen

  2. The Percentage of Subjects With Clinical Response at End of Therapy (EOT) Visit in the MITT Population [ Time Frame: EOT; Within 24 hours of last study drug administration ]
    Clinical response is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.

  3. The Percentage of Subjects With Clinical Response at End of Therapy in the ME Population [ Time Frame: EOT; Within 24 hours of last study drug administration ]
    Clinical response is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.

  4. The Percentage of Subjects With Clinical Response at Long Term Follow-Up (LFU) in the MITT Population [ Time Frame: LFU; 38 to 45 days after first study drug administration ]
    Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit.

  5. The Percentage of Subjects With Clinical Response at LFU Visit in the ME Population [ Time Frame: LFU; 38 to 45 days after first study drug administration ]
    Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01445678


Locations
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Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Investigators
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Study Director: Ellie Hershberger, Pharm.D Cubist Pharmaceuticals LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01445678    
Obsolete Identifiers: NCT01445665
Other Study ID Numbers: 7625A-004
CXA-cIAI-10-09 ( Other Identifier: Cubist Study Number )
CXA-cIAI-10-08 ( Other Identifier: Cubist Study number for 7625A-003 )
First Posted: October 4, 2011    Key Record Dates
Results First Posted: January 15, 2015
Last Update Posted: November 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Keywords provided by Cubist Pharmaceuticals LLC:
cIAI
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Intraabdominal Infections
Disease Attributes
Pathologic Processes
Metronidazole
 Meropenem
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents