A Phase III, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Efficacy and Safety of Cefepime-Tazobactam vs. Meropenem followed by Optional Oral Therapy in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults - Phase III study of cefepime-tazobactam (FEP-TAZ) in cUTI or AP

Wockhardt Bio AG0 个研究点目标入组 1,004 人开始时间: 2018年7月2日最近更新: 2021年8月2日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Wockhardt Bio AG
入组人数: 1,004

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Male or female =18 years of age
•2. Provide a signed written informed consent prior to any study-specific procedures
•3. Meet the following clinical criteria for either cUTI or AP:
•a. Have at least TWO of the following new-onset or worsening symptoms or signs:
•Fever (oral, tympanic, or rectal temperature >38°C [>100.4°F]), which must be observed and documented by a health care provider
•Nausea or vomiting
•Dysuria, increased urinary frequency, or urinary urgency
•Lower abdominal, suprapubic, or pelvic pain
•b. Have at least ONE of the following complicating factors:
•Use of intermittent bladder catheterization or presence of an indwelling bladder catheter (Note: indwelling bladder catheters that have been in place for >24 h prior to Screening must be removed or replaced prior to collection of the screening urine for urinalysis and culture, unless removal or replacement is considered unsafe or contraindicated)
•Current known functional or anatomical abnormality of the urogenital tract, including anatomic malformations or neurogenic bladder, or with a post-void residual urine volume of =100 mL
•Complete or partial obstructive uropathy (e.g., nephrolithiasis, tumor, fibrosis, urethral stricture) that is expected to be medically or surgically treated during IV study drug therapy (prior to EOIV)
•Azotemia, defined as BUN >20 mg/dL (or blood urea >42.8 mg/dL) or serum creatinine >1.4 mg/dL, due to known prior intrinsic renal disease
•Documented history of urinary retention in men (e.g., previously diagnosed benign prostatic hypertrophy) with a post-void residual urine volume of =100 mL
•B. AP, defined as acute flank pain (onset within 7 days prior to randomization) or costovertebral angle tenderness on physical examination, plus at least ONE of the following new-onset or worsening symptoms or signs:
•Fever (oral, tympanic, or rectal temperature >38°C [>100.4°F]), which must be observed and documented by a health care provider
•Nausea or vomiting
•Dysuria, increased urinary frequency, or urinary urgency
•Note: If criteria for both cUTI and AP are met, the infection type will be considered a cUTI for randomization and analysis purposes.
•4. Evidence of pyuria within 48 h prior to randomization, as determined by a midstream clean catch or catheterized urine specimen with ONE of the following findings:
•Positive leukocyte esterase on urinalysis, (where positive result is at least ++ or moderate as indicated on the urine dipstick provided in the laboratory kit),
•WBC count =10 cells/mm3 in unspun urine
•WBC count =10 cells/ hpf in urine sediment
•Note: The screening urine sample (within 48 h prior to randomization) will be submitted for culture; however, subjects may be randomized and administered study drug therapy prior to knowledge of baseline urine culture results
•5. If known, urine culture taken within 48 hours prior to randomization contains =105 CFU/mL of a Gram-negative uropathogen likely to be susceptible to meropenem
•6. Expectation, in the judgment of the Investigator, that any implanted urinary instrumentation (e.g., nephrostomy tubes, ureteric stents) will be surgically removed or replaced before or within 24 h after randomization, unless removal or replacement is considered unsafe or contraindicated; note that temporary bladder catheters that have been in place for >24 h prior to Screening must be removed or replaced prior to collection of the screening urine for urinalysis and culture, unless removal or r

排除标准

•1. Known or suspected disease or condition that, in the opinion of the investigator, may confound the assessment of efficacy, including but not limited to the following:
•Perinephric or renal abscess
•Uncomplicated lower UTI (e.g., cystitis)
•Recent trauma to the pelvis or urinary tract
•Polycystic kidney diseases
•Chronic vesicoureteral reflux
•Previous or planned cystectomy or permanent urinary diversion (e.g., ileal loop, cutaneous ureterostomy)
•Acute or chronic bacterial prostatitis, orchitis, or epididymitis
•Concurrent non-renal source of infection (e.g., endocarditis, osteomyelitis, abscess, meningitis, pneumonia)
•Previous or planned renal transplant or subject requiring hemodialysis
•cUTI or AP that is known at Screening to be caused by a pathogen that is resistant to meropenem, including infection caused by fungi (e.g., candiduria) or mycobacteria (e.g., urogenital tuberculosis)
•2. Receipt of potentially-effective systemic antibacterial therapy within 72 h prior to randomization, with the exception of:
•a. Receipt of a single dose of a short-acting antibacterial agent within 72 h of randomization (Appendix I) (no more than 15% of subjects will be enrolled with this exception), OR
•b. Receipt of >48 h of prior antibiotic therapy and (1) in the Investigator's opinion, failed that prior antibiotic therapy (i.e., worsening signs and symptoms), AND (2) documented to have cUTI or AP caused by a pathogen that is nonsusceptible to the prior antibiotic therapy, AND (3) the causative pathogen is known to be either susceptible, intermediate, or of unknown susceptibility to meropenem
•3. Rapidly progressive or terminal illness with a high risk of mortality due to any cause, including but not limited to acute hepatic failure, respiratory failure, or septic shock, such that the subject is unlikely to survive the study period
•4. Pregnant or breastfeeding women
•5. Likely to require > 10 days of antibiotic treatment to cure the current acute cUTI, or likely to receive any additional systemic antimicrobial therapy during the study period (including antibacterial, antimycobacterial, or antifungal therapy or prophylaxis) other than study drug, with the exception of (1) a single oral dose of any antifungal treatment for vaginal candidiasis, or (2) a glycopeptide (e.g., vancomycin), oxazolidinone (e.g., linezolid), or daptomycin given for a Gram-positive infection
•6. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required to relieve an obstruction or place a stent or nephrostomy)

研究者

发起方

Wockhardt Bio AG

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