Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections
NCT ID: NCT01445678
Last Updated: 2018-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
494 participants
INTERVENTIONAL
2011-12-23
2013-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CXA-201 and Metronidazole as treatment for cIAI
CXA-201 and metronidazole
CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
Meropenem as treatment for cIAI
Meropenem
Meropenem IV infusion (1000mg q8h) for 4-14 days
Interventions
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CXA-201 and metronidazole
CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
Meropenem
Meropenem IV infusion (1000mg q8h) for 4-14 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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Ellie Hershberger, Pharm.D
Role: STUDY_DIRECTOR
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Locations
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Springfield, Illinois, United States
Boston, Massachusetts, United States
Robbinsdale, Minnesota, United States
Columbus, Ohio, United States
Ciudadelo-Buenos Aires, Buenos Aires, Argentina
General Rodríguez, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
Loma Hermosa, Buenos Aires, Argentina
Luján, Buenos Aires, Argentina
Merlo, Buenos Aires, Argentina
Tandil, Buenos Aires, Argentina
Vicente López, Buenos Aires, Argentina
Paraná, Entre Ríos Province, Argentina
Corrientes, , Argentina
Córdoba, , Argentina
Santa Fe, , Argentina
Pleven, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Temuco, Cautin, Chile
Santiago, , Chile
Split, Dalmatia, Croatia
Zagreb, , Croatia
Kohtla-Järve, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Freiburg im Breisgau, Baden-Weurttemberg, Germany
Heidelberg, Baden-Wurttemberg, Germany
Gyula, Bekes County, Hungary
Szeged, Csongrád megye, Hungary
Szentes, Csongrád megye, Hungary
Győr, Győr-Moson-Sopron, Hungary
Zalaegerszerg, Zala County, Hungary
Budapest, , Hungary
Kaposvár, , Hungary
Kecskemét, , Hungary
Vác, , Hungary
Kfar Saba, Sharon, Israel
Tel Litwinsky, Tel Aviv, Israel
Beer Yahkov, , Israel
Haifa, , Israel
Liepāja, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Klaipėda, , Lithuania
Šiauliai, , Lithuania
Vilnius, , Lithuania
Chisinau, , Moldova
Krakow, Lesser Poland Voivodeship, Poland
Lubin, Lublin Voivodeship, Poland
Wołomin, Masovian Voivodeship, Poland
Szczecin, West Pomeranian Voivodeship, Poland
Lodz, Łódź Voivodeship, Poland
Belgrade, , Serbia
Krafujevac, , Serbia
Niš, , Serbia
Novi Sad, , Serbia
Wŏnju, Gangwon-do, South Korea
Incheon, Gyeonggi-do, South Korea
Suwon, Gyeonggi-do, South Korea
Seoul, , South Korea
Countries
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References
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Popejoy MW, Long J, Huntington JA. Analysis of patients with diabetes and complicated intra-abdominal infection or complicated urinary tract infection in phase 3 trials of ceftolozane/tazobactam. BMC Infect Dis. 2017 May 2;17(1):316. doi: 10.1186/s12879-017-2414-9.
Xiao Y, Tong ML, Liu LL, Lin LR, Chen MJ, Zhang HL, Zheng WH, Li SL, Lin HL, Lin ZF, Xing HQ, Niu JJ, Yang TC. Novel predictors of neurosyphilis among HIV-negative syphilis patients with neurological symptoms: an observational study. BMC Infect Dis. 2017 Apr 26;17(1):310. doi: 10.1186/s12879-017-2339-3.
Kullar R, Wagenlehner FM, Popejoy MW, Long J, Yu B, Goldstein EJ. Does moderate renal impairment affect clinical outcomes in complicated intra-abdominal and complicated urinary tract infections? Analysis of two randomized controlled trials with ceftolozane/tazobactam. J Antimicrob Chemother. 2017 Mar 1;72(3):900-905. doi: 10.1093/jac/dkw486.
Miller B, Popejoy MW, Hershberger E, Steenbergen JN, Alverdy J. Characteristics and Outcomes of Complicated Intra-abdominal Infections Involving Pseudomonas aeruginosa from a Randomized, Double-Blind, Phase 3 Ceftolozane-Tazobactam Study. Antimicrob Agents Chemother. 2016 Jun 20;60(7):4387-90. doi: 10.1128/AAC.03074-15. Print 2016 Jul.
Solomkin J, Hershberger E, Miller B, Popejoy M, Friedland I, Steenbergen J, Yoon M, Collins S, Yuan G, Barie PS, Eckmann C. Ceftolozane/Tazobactam Plus Metronidazole for Complicated Intra-abdominal Infections in an Era of Multidrug Resistance: Results From a Randomized, Double-Blind, Phase 3 Trial (ASPECT-cIAI). Clin Infect Dis. 2015 May 15;60(10):1462-71. doi: 10.1093/cid/civ097. Epub 2015 Feb 10.
Other Identifiers
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CXA-cIAI-10-09
Identifier Type: OTHER
Identifier Source: secondary_id
CXA-cIAI-10-08
Identifier Type: OTHER
Identifier Source: secondary_id
7625A-004
Identifier Type: -
Identifier Source: org_study_id
NCT01445665
Identifier Type: -
Identifier Source: nct_alias
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