PER-019-01已完成未知
PROSPECTIVE, RANDOMIZED STUDY TO COMPARE CIPROFLOXACIN (IN ORAL SUSPENSION, IV SEQUENTIAL TREATMENT, ORAL SUSPENSION OR EXCLUSIVELY IV) VERSUS ESTABLISHED COMPARATIVE REGIMES (EITHER CEFIXIME ORAL SUSPENSION, SEQUENTIAL TREATMENT WITH CEFTAZIDIME IV -> CEFIXIMA ORAL SUSPENSION OR CEFTAZIDIME EXCLUSIVELY IV) FOR THE TREATMENT OF PEDIATRIC PATIENTS WITH COMPLICATED INFECTIONS OF THE URINARY TRACT OR PIELONEFRITIS.
BAYER S.A.,0 个研究点目标入组 0 人开始时间: 2001年5月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •age> 1 year but <17 years
- •written informed consent signed by parent / legal guardian and patient (if applicable)
- •a positive urine culture should be obtained by means of the medium jet method, intermittent catheterization, permanent catheterization or suprapubic puncture. Positive is defined as: urine obtained by the medium jet method:> 10 6 colony forming units per milliliter (CFU / ml); urine obtained by permanent urethral catheter; > 10 6 CFU / ml; urine obtained by aseptic intermittent urethral catheterization:> 10 6 (CFU / ml); and urine obtained by suprapubic puncture:> 10 6 (CFU / ml).
- •present a current episode of complicated UTI
- •Patients with complicated UTI must also meet one of the following criteria:
- •o permanent catheter or use of intermittent catheterization
- •o obstructive uropathy due to obstruction of the bladder outlet
- •o vesicoureteral reflux or other urological abnormalities
- •o functional or neurogenic micturition disorders with significant impact on bladder emptying or pressure profile in the bladder.
- •o recurrent UTI, defined as two or more acute UTIs in a 6-month period
- •o evidence that the current UTI may be caused by a resistant uropathogen, including evidence that the current episode is a new infection, or a large child or adolescent receiving chronic or intermittent antimicrobial suppression with unresolved vesicoureteral reflux.
- •Patients with pyelonephritis should have fever f> 38 ° C {100.4 ° F ^ oral or> 38.6 ° C (101.4 ° F> rectal) AND at least one of the following symptoms:
- •o nausea and / or vomiting
- •o sensitivity in the costovertebral angle
排除标准
- •Have a known hypersensitivity to ANY of the study drug regimens or related compounds, including fluoroquinolones or cephalosporins, or severe hypersensitivity to penicillin.
- •They have participated in a clinical study in the month prior to this study.
- •They have been previously enrolled in this clinical study.
- •They have significant liver failure (ALT / AST and / or basal bilirubin> 3 times the upper limit of normal).
- •They have significant confirmed renal failure (calculated creatinine clearance <30 ml / min / 1.73m2).
- •Pregnant or lactating patients, or who are sexually active and use an unreliable method of contraception,
- •Patients who depend on a pediatric formula for nutrition in such a way that it is impossible to receive the dose of study medication two hours before or six hours after a meal.
- •Patients who were previously treated with an effective antibacterial agent at a therapeutic dose within 48 hours prior to screening, that is, an antimicrobial that demonstrated a reduction that can be determined clinically from the signs and symptoms of this cTU.
- •Require any concomitant systemic antibacterial agent.
- •They present evidence of calculations.
- •Have a confirmed risk of seizures, a history of seizure disorders or trauma to head injuries, who are currently receiving anticonvulsants or who have had a stroke in the past two months.
- •They present AIDS (guideline when a cell count is available: CD4 count <200 / mm3).
- •They have received treatment with quinolones in the 14 days prior to entering the study.
- •They have a confirmed underlying rheumatologic disease, joint problems secondary to trauma or pre-existing conditions that are known to be associated with arthropathy. Patients who present conditions that prevent performing a reliable series of musculoskeletal exams should be excluded from participation in the study.
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