Complicated Urinary Tract Infections (cUTIs)
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient must be 18 to 90 years of age, inclusive. 2.Female patient is authorized to participate in this clinical study if she meets the following criteria ,is surgically sterilize or postmenopausal for at least 1 year or is capable of having children and agrees not to attempt pregnacy while received IV study therapy and for a period of 28 days after. 3.Patient has pyuria as determined by a midstream clean catch or catheterized urine specimen with =10 white blood cells (WBCs) per high-power field on standard examination of urine sediment or =10 WBCs/mm3 in unspun urine. 4.Demonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 617 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 347
Exclusion criteria
Exclusion criteria: 1.Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or Doripenemine culture 2.Where a urine culture result is available, patient’s urine culture at study entry isolates more than 2 microorganisms regardless of the colony count or patient has a confirmed fungal UTI. 3.Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant. 4.Patient is immunocompromised. 5.Patient is considered unlikely to survive the 6 to 8 week study period or have a rapidly progressive or terminal illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the noninferiority of ceftazidime-avibactam (CAZ-AVI, formerly CAZ104) compared with doripenem with respect to the following coprimary endpoints in the microbiological modified intent-to-treat (mMITT) analysis set: •Symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) and resolution of, or improvement in, flank pain based on the patient-reported symptom assessment response at the Day 5 visit •Both per-patient microbiological eradication and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the Test of Cure (TOC) visit ;Secondary Objective: •To determine the efficacy of CAZ-AVI compared with doripenem with respect to the per patient microbiological response at the End of IV Therapy, TOC, and Late Follow-Up visits •To determine the efficacy of CAZ-AVI compared with doripenem with respect to the symptomatic resolution of UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on patient-reported symptom assessment at TOC and LFU visits •To determine the efficacy of CAZ-AVI compared with doripenem with respect to the per pathogen microbiological response at the EOT (IV), TOC, and LFU visits in patients who are in the mMITT, ME, and extended ME analysis sets ;Primary end point(s): •The proportion of patients with symptomatic resolution of UTI-specific symptoms based on patient-reported symptom assessment response at the Day 5 visit. Timeframe: Day 5 after start of study drug •The proportion of patients with a per patient microbiological eradication and symptomatic resolution of all UTI-specific symptoms based on the patient-reported symptom assessment response. Timeframe: 21 to 25 days after start of study drug ;Timepoint(s) of evaluation of this end point: Primary Outcome measure | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Within 21 to 25 days and 45 to 52 days;Secondary end point(s): •The proportion of patients with a favorable per patient microbiological response in the microbiological mITTanalysis sets. Timeframe: within 24 hours after last day of the study drug, 21 to 25 days and 45 to 52 days after the start of the study drug •The proportion of patients with symptomatic resolution of all UTI-specific symptoms based on the patient-reported symptom assessment response. Timeframe: within 21 to 25 days and 45 to 52 days after the start of the study drug •The proportion of favorable per-pathogen microbiological response in the microbiological modified Intent-To-Treat, microbiologically evaluable, and extended microbiologically evaluable analysis sets Timeframe: within 24 hours after last day of the study drug, 21 to 25 days and 45 to 52 days after the start of the study drug •The proportion of patients with an investigator-determined clinical cure in the microbiological mITT analysis sets. Timeframe: within 24 hours after last day of the study drug, 21 to 25 days and 45 to 52 days after the start of the study drug •The per pathogen microbiologic response by minimum inhibitory concentration in the microbiological mITT analysis sets. Timeframe: within 24 hours after last day of the study drug, 21 to 25 days and 45 to 52 days after the start of the study drug •The proportion of patients with favorable investigator clinical response assessment in the microbiological mITT analysis sets. Timeframe: within 21 to 25 days after the start of the study drug •The time to first defervescence while on IV study therapy in patients in the microbiological mITT analysis sets who have fever at study entry. Timeframe: any time after the start to study drug to end of IV study therapy. •The safety/tolerability by incidence/severity of adverse events and serious adverse events, vital signs, clinical laboratory tests, ECGs and physical exams Timefr | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Croatia, Czech Republic, France, Germany, Greece, Hungary, India, Israel, Japan, Korea, Republic of, Mexico, Poland, Portugal, Romania, Russian Federation, Slovakia, Taiwan, Ukraine
Contacts
Public ContactInformation Centre
AstraZeneca
Outcome results
None listed