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).
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
494
CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
Meropenem IV infusion (1000mg q8h) for 4-14 days
The Percentage of Subjects With Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population
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.
Time frame: TOC; 26-30 days after start of study drug administration
The Percentage of Subjects With Microbiological Outcome of Success at the TOC Visit in the Microbiologically Evaluable (ME) Population
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
Time frame: 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
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.
Time frame: EOT; Within 24 hours of last study drug administration
The Percentage of Subjects With Clinical Response at End of Therapy in the ME Population
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.
Time frame: 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
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Springfield, Illinois, United States
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Boston, Massachusetts, United States
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Robbinsdale, Minnesota, United States
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Columbus, Ohio, United States
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Ciudadelo-Buenos Aires, Buenos Aires, Argentina
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General Rodríguez, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Loma Hermosa, Buenos Aires, Argentina
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Luján, Buenos Aires, Argentina
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Merlo, Buenos Aires, Argentina
...and 51 more locations
Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit.
Time frame: LFU; 38 to 45 days after first study drug administration
The Percentage of Subjects With Clinical Response at LFU Visit in the ME Population
Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit
Time frame: LFU; 38 to 45 days after first study drug administration