EUCTR2009-015953-18-Outside-EU/EEA进行中（未招募）不适用
A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Complicated Urinary Tract Infections
Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium0 个研究点目标入组 140 人开始时间: 2011年9月14日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
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- Have evidence of pyuria as demonstrated by either of the following:
- •o A urine specimen that is positive for leukocyte esterase via urine dipstick or urinalysis
- •o A urine specimen with =10 WBCs per microliter from an unspun sample or =5 WBCs per high power field from a centrifuged specimen.
- •2- Have a current documented or suspected cUTI or pyelonephritis as indicated by the following clinical signs or symptoms:
- •COMPLICATED URINARY TRACT INFECTION
- •o Symptomatic cUTI
- •Children 3 months to <2 years of age
- •Must have at least ONE of the following signs or symptoms:
- •– Recent weight loss or failure to thrive
- •– Abdominal pain
- •– Irritability
- •– Poor feeding
- •– Decrease in normal level of activity
- •– have at least ONE complicating factor (see below)
- •Children 2 to <18 years of age
- •Must have at least ONE of the following signs or symptoms:
- •– Increased urinary frequency
- •– Suprapubic or abdominal pain
- •– Secondary urinary incontinence
- •– have at least ONE complicating factor (see below)
- •o Asymptomatic cUTI
- •Children 3 months to <18 years of age
- •Must be unable to perceive symptoms of UTI due to congenital or acquired spinal cord injury or abnormality
- •have at least ONE complicating factor (see below)
- •Complicating Factors for All Age Categories (3 months to <18 years of age): All subjects enrolled with a diagnosis of complicated UTI must have at least ONE of the following complicating factors:
- •- Indwelling urinary catheter or other indwelling urinary tract instrumentation that is anticipated to be removed during the course of IV study drug therapy
- •- Use of intermittent urinary catheterization
- •- Urogenital surgery within the 7 days before administration of the first dose of IV study drug
- •- Known functional or anatomic abnormality of the urogenital tract
- •- Obstructive uropathy where the obstruction is likely to resolve or be relieved during the course of IV study drug therapy administration
- •- Previously documented vesicoureteral reflux
- •- Neurogenic disturbances of micturition with significant impact on bladder emptying with bladder residual volume =50 mL for children weighing <40 kg and =100 mL for children weighing =40 kg as previously determined by voiding cystourethrogram (VCUG) or ultrasound or urinary catheterization immediately post void. (Chang 2009)
- •- Recurrent UTI (defined as 2 or more previous UTIs within a 12-month period)
- •- Evidence that the current UTI may be caused by a resistant uropathogen including a suspected breakthrough infection in a child receiving chronic antimicrobial prophylaxis for the prevention of UTI
- •- Prior documentation of congenital structural or functional urologic
- •abnormality including but not limited to findings from prenatal or postnatal ultrasound or postnatal VCUG
- •PYELONEPHRITIS
- •Subjects in all age categories (3 months to <18 years of age) enrolled with a diagnosis of pyelonephritis must have both:
- •Evidence of systemic inflammatory response as demonstrated by at least ONE of the following:
- •o Fever (oral temperature >38.0C, tympanic temperature >38.3C, or rectal or core temperature >38.8C) or hypothermia (rectal or core temperature <35.0C)
- •o Have leukocytosis defined as WBC >or=15,000 cells/microL OR >or=15% immature neutrophils, regardless of the total peripheral white cell count
- •Have at least ONE of the following signs or symptoms:<b
排除标准
- •1 - Have a history of hypersensitivity reactions to carbapenems, cephalosporins, penicillins, or other beta-lactam antibiotics. Note: Subjects with a history of mild non-urticarial skin rash temporally related to but considered not associated with the previous use of beta-lactam antibiotics are permitted to enroll in the study. For such subjects, there must be a description of the rash and documentation by the investigator that upon review of the history it is his/her opinion that the rash was unlikely due to any of the above-mentioned classes of drugs for the subject to qualify for inclusion in the study.
- •2 - Concomitant infection including but not limited to suspected or confirmed meningitis or other central nervous system infection requiring systemic antibiotic or antifungal therapy at the time of randomization. (Clarification: possible bacteremia with the presumed same urinary pathogen is acceptable).
- •3 - Received any amount systemic antibiotic therapy within 96 hours (4 days) before obtaining the pretreatment baseline urine culture specimen. (Exception: Subjects receiving oral antibiotics for UTI prophylaxis and are suspected to have a breakthrough UTI are eligible to enroll if all other eligibility criteria are met including obtaining a baseline urine culture specimen).
- •4 - Have received more than 24 hours of systemic antibiotic therapy after obtaining the pretreatment baseline urine culture specimen
- •5 - Girls who are pregnant or are nursing a child or are menarchal, and, if sexually active, are not practicing a highly effective method of birth control (eg, prescription hormonal contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method, eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel, male partner sterilization) as local regulations permit, before screening and do not agree to continue using a highly effective method of birth control (as previously described) for 30 days after administration of the last dose of study drug therapy. Note: for all menarchal girls, confirm a negative urine or serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening, before enrolling the subject into the study.
- •6 - Have a history of uncontrolled epilepsy defined as at least 1 seizure within the 6 months before randomization
研究者
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