The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated urinary tract infections as compared to a comparator group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
137
125mg/500mg TID
4 x daily
Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit
Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Time frame: 5 to 9 days post-therapy
Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit
Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required
Time frame: End of IV therapy (4 to 14 days)
Clinical Outcome in CE Patients at the TOC Visit
Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required
Time frame: 5 to 9 days post-therapy
Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit
Cure: all or most pre-therapy signs and symptoms of the index infection showed no evidence of resurgence and no additional antibiotic was required
Time frame: 4 to 6 weeks post-therapy
Microbiological Outcome in ME Patients at the End of IV Therapy Visit
Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Time frame: End of IV therapy (4 to 14 days)
Microbiological Outcome in ME Patients at the LFU Visit
Sustained eradication: a uropathogen found at entry at \>10\^5 CFU/mL remained \<10\^4 CFU/mL
Time frame: 4 to 6 weeks post-therapy
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit
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Alabama Research Center
Birmingham, Alabama, United States
Southeast Alabama Medical Center
Dothan, Alabama, United States
Providence Hospital
Mobile, Alabama, United States
Arizona Pulmonary Specialists LTD
Phoenix, Arizona, United States
Sharp Chula Vista Medical Center
Chula Vista, California, United States
Synergy Clinical Research Center
Escondido, California, United States
Novellus Research Sites
Fountain Valley, California, United States
Novellus Research Sites
Long Beach, California, United States
Modesto Clinical Research
Modesto, California, United States
Tri City Medical Center
Oceanside, California, United States
...and 49 more locations
Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Time frame: End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit
Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Time frame: End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit
Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Time frame: End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit
Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Time frame: End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit
Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Time frame: End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit
Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Time frame: 5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit
Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Time frame: 5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit
Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Time frame: 5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit
Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Time frame: 5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit
Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Time frame: 5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit
Sustained eradication: a uropathogen found at entry at \>10\^5 CFU/mL remained \<10\^4 CFU/mL
Time frame: 4 to 6 weeks post-therapy
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit
Sustained eradication: a uropathogen found at entry at \>10\^5 CFU/mL remained \<10\^4 CFU/mL
Time frame: 4 to 6 weeks post-therapy
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit
Sustained eradication: a uropathogen found at entry at \>10\^5 CFU/mL remained \<10\^4 CFU/mL
Time frame: 4 to 6 weeks post-therapy
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit
Sustained eradication: a uropathogen found at entry at \>10\^5 CFU/mL remained \<10\^4 CFU/mL
Time frame: 4 to 6 weeks post-therapy