The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated intra-abdominal infections as compared to a comparator group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
204
IV TID
IV TID
Number of Participants With Clinical Response at the Test of Cure (TOC) Visit
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were microbiologically evaluable (ME) at baseline.
Time frame: Test of cure visit: 2 weeks post-therapy (Day 28)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after last dose of study treatment that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks)
Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline.
Time frame: End of IV therapy: From Day 5 to Day 14
Number of Participants With Clinical Response at the Late Follow-up Visit
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline.
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University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center Dept of Surgery
Los Angeles, California, United States
Michael S. Somero Research Division
Palm Springs, California, United States
Henry Ford Health System
Detroit, Michigan, United States
Mercury Street Medical Group
Butte, Montana, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
Summa Health Systems
Akron, Ohio, United States
Remington-Daviss Inc
Columbus, Ohio, United States
ID Clinical Research Ltd
Toledo, Ohio, United States
UMHAT Sveti Georgi 3rd Clinical of Surgery
Plovdiv, Bulgaria
...and 35 more locations
Time frame: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Number of Participants With Microbiological Response at the Test of Cure Visit
Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline.
Time frame: Test of cure visit: 2 weeks post-therapy (Day 28)
Number of Participants With Microbiological Response at the End of IV Therapy
Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline.
Time frame: End of IV therapy: From Day 5 to Day 14
Number of Participants With Microbiological Response at the Late Follow-up Visit
Favorable: eradication (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication (absence of material to culture in a patient who had responded clinically to treatment)
Time frame: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.
Time frame: Test of cure visit: 2 weeks post-therapy (Day 28)
Number of Participants With Clinical Response in CE Participants at the End of IV Therapy
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.
Time frame: End of IV therapy: From Day 5 to Day 14
Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.
Time frame: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)