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:
NCT01445665
First received: September 26, 2011
Last updated: September 20, 2013
Last verified: September 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: 500
Study Start Date: October 2011
Study Completion Date: September 2013
Primary Completion Date: August 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: NCT01445665

  Hide Study Locations
Locations
United States, Florida
Penascola, Florida, United States
Weston, Florida, United States
United States, Indiana
Carmel, Indiana, United States
Indianapolis, Indiana, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Somers Point, New Jersey, United States
Teaneck, New Jersey, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Texas
Houston, Texas, United States
Australia, Queensland
Cairns, Queensland, Australia
Nambour, Queensland, Australia
Southport, Queensland, Australia
Australia, Victoria
Clayton, Victoria, Australia
Heidelberg, Victoria, Australia
Belgium
Edegem, Antwerpen, Belgium
Brussel, Brussels, Belgium
Hasselt, Limburg, Belgium
Brugge, West-Vlaanderen, Belgium
Brazil
Belo Horizonte, Minas Gerais, Brazil
Porto Alegre, Rio Grande de Sul, Brazil
Campinas, Sao Paulo, Brazil
Sao Jose de Rio Preto, Sao Paulo, Brazil
Sao Paulo, Brazil
Colombia
Armenia, Colombia
Bogota, Colombia
Georgia
Tbilsi, Georgia
Latvia
Daugavpils, Latvia
Liepaja, Latvia
Rezekne, Latvia
Riga, Latvia
Valmiera, Latvia
Mexico
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo Leon, Mexico
San Luis Potosi, San Luis Botosi, Mexico
Culiacan, Sinaloa, Mexico
Chihuahua, Mexico
Veracruz, Mexico
Peru
Bellavista, Callo, Peru
Cercado de Lima, Lima, Peru
San Isidro, Lima, Peru
San Juan de Miraflores, Lima, Peru
Lima, Peru
Trujillo, Peru
Romania
Cluj-Napoca, Cluj, Romania
Craiova, Dolj, Romania
Timisoara, Timis, Romania
Brasov, Romania
Bucuresti, Romania
Russian Federation
Tomsk, Moscow City, Russian Federation
Saint Petersburg, St. Petersburg, Russian Federation
Kaluga, Russian Federation
Kemerovo, Russian Federation
Moscow, Russian Federation
Nizhnii Novgorod, Russian Federation
Ufa, Russian Federation
Volgograd, Russian Federation
Slovakia
Banska Bystrica, Slovakia
Bardejov, Slovakia
Galanta, Slovakia
Trencin, Slovakia
South Africa
Observatory, Cape Town, South Africa
Worcester, Western Cape, South Africa
Johannesburg, South Africa
Spain
Sabadell, Barcelona, Spain
Terrassa, Barcelona, Spain
Santiago de Compostela, La Coruna, Spain
Madrid, Spain
Ukraine
Zaporozhzhya, Zaporizhzhya, Ukraine
Cherkasy, Ukraine
Dnipropetrovsk, Ukraine
Ivano-Frankivsk, Ukraine
Kharkiv, Ukraine
Kiev, Ukraine
Odessa, Ukraine
Uzhgorod, Ukraine
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: NCT01445665     History of Changes
Other Study ID Numbers: CXA-cIAI-10-08
Study First Received: September 26, 2011
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:
cIAI
Complicated

Additional relevant MeSH terms:
Metronidazole
Meropenem
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 23, 2014