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

October 18, 2018 updated by: Cubist Pharmaceuticals LLC

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
494

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina
      • Corrientes, Argentina
      • Santa Fe, Argentina
    • Buenos Aires
      • Ciudadelo-Buenos Aires, Buenos Aires, Argentina
      • General Rodriguez, Buenos Aires, Argentina
      • La Plata, Buenos Aires, Argentina
      • Loma Hermosa, Buenos Aires, Argentina
      • Lujan, Buenos Aires, Argentina
      • Merlo, Buenos Aires, Argentina
      • Tandil, Buenos Aires, Argentina
      • Vicente Lopez, Buenos Aires, Argentina
    • Entre Rios
      • Parana, Entre Rios, Argentina
  • Bulgaria
      • Pleven, Bulgaria
      • Sofia, Bulgaria
      • Varna, Bulgaria
  • Chile
      • Santiago, Chile
    • Cautin
      • Temuco, Cautin, Chile
  • Croatia
      • Zagreb, Croatia
    • Dalmatia
      • Split, Dalmatia, Croatia
  • Estonia
      • Kohtla-Jarve, Estonia
      • Tallinn, Estonia
      • Tartu, Estonia
  • Germany
    • Baden-Weurttemberg
      • Freiburg, Baden-Weurttemberg, Germany
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Germany
  • Hungary
      • Budapest, Hungary
      • Kaposvar, Hungary
      • Kecskemet, Hungary
      • Vac, Hungary
    • Bekes
      • Gyula, Bekes, Hungary
    • Csongrad
      • Szeged, Csongrad, Hungary
      • Szentes, Csongrad, Hungary
    • Gyor-Moson-Sopron
      • Gyor, Gyor-Moson-Sopron, Hungary
    • Zala
      • Zalaegerszerg, Zala, Hungary
  • Israel
      • Beer Yahkov, Israel
      • Haifa, Israel
    • Sharon
      • Kfar Saba, Sharon, Israel
    • Tel Aviv
      • Tel Hashomer, Tel Aviv, Israel
  • Korea, Republic of
      • Seoul, Korea, Republic of
    • Gangwon-Do
      • Wonju, Gangwon-Do, Korea, Republic of
    • Gyeonggi-Do
      • Incheon, Gyeonggi-Do, Korea, Republic of
      • Suwon-si, Gyeonggi-Do, Korea, Republic of
  • Latvia
      • Liepaja, Latvia
      • Riga, Latvia
  • Lithuania
      • Kaunas, Lithuania
      • Klaipeda, Lithuania
      • Siauliai, Lithuania
      • Vilnius, Lithuania
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of
  • Poland
    • Lodzkie
      • Lodz, Lodzkie, Poland
    • Lubelskie
      • Lubin, Lubelskie, Poland
    • Malopolskie
      • Krakow, Malopolskie, Poland
    • Mazowieckie
      • Wolomin, Mazowieckie, Poland
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland
  • Serbia
      • Belgrade, Serbia
      • Krafujevac, Serbia
      • Nis, Serbia
      • Novi Sad, Serbia
  • United States
    • Illinois
      • Springfield, Illinois, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Minnesota
      • Robbinsdale, Minnesota, United States
    • Ohio
      • Columbus, Ohio, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
TOC; 26-30 days after start of study drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
TOC; 26-30 days after start of study drug administration
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.
EOT; Within 24 hours of last study drug administration
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.
EOT; Within 24 hours of last study drug administration
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.
LFU; 38 to 45 days after first study drug administration
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
LFU; 38 to 45 days after first study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cubist Pharmaceuticals LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ellie Hershberger, Pharm.D, Cubist Pharmaceuticals LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 23, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 3, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7625A-004
  • CXA-cIAI-10-09 (OTHER: Cubist Study Number)
  • CXA-cIAI-10-08 (OTHER: Cubist Study number for 7625A-003)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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