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

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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

Tracking Information
First Submitted Date  ICMJE September 26, 2011
First Posted Date  ICMJE October 4, 2011
Results First Submitted Date  ICMJE January 9, 2015
Results First Posted Date  ICMJE January 15, 2015
Last Update Posted Date November 16, 2018
Actual Study Start Date  ICMJE December 23, 2011
Actual Primary Completion Date October 3, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2011)
The proportion of subjects with clinical outcome of cure [ Time Frame: 26-30 days after start of study drug administration ]
Change History Complete list of historical versions of study NCT01445678 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2015)
  • 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
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2011)
  • The proportion of subjects with microbiological outcome of success [ Time Frame: 26-30 days after start of study drug administration ]
  • 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 ]
  • 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections
Official Title  ICMJE 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
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Complicated Intra-abdominal Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2013)
494
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2011)
780
Actual Study Completion Date  ICMJE October 15, 2013
Actual Primary Completion Date October 3, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Bulgaria,   Chile,   Croatia,   Estonia,   Germany,   Hungary,   Israel,   Korea, Republic of,   Latvia,   Lithuania,   Moldova, Republic of,   Poland,   Serbia,   United States
Removed Location Countries India
 
Administrative Information
NCT Number  ICMJE NCT01445678
Other Study ID Numbers  ICMJE 7625A-004
CXA-cIAI-10-09 ( Other Identifier: Cubist Study Number )
CXA-cIAI-10-08 ( Other Identifier: Cubist Study number for 7625A-003 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Cubist Pharmaceuticals LLC
Study Sponsor  ICMJE Cubist Pharmaceuticals LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ellie Hershberger, Pharm.D Cubist Pharmaceuticals LLC
PRS Account Cubist Pharmaceuticals LLC
Verification Date October 2018

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