Multicentre, prospective, comparative, randomized, double-blind, double-dummy study to assess the efficacy and safety of cefditoren pivoxil versus ciprofloxacin in acute uncomplicated cystitis.

TEDEC-MEIJI FARMA, S.A.0 个研究点目标入组 580 人开始时间: 2007年11月23日最近更新: 2012年4月18日

适应症

试验速览

暂无简介。

•Non-pregnant adult females (> or =18)
•Clinical signs and symptoms of uncomplicated acute cystitis (dysuria, urgency, frequency, suprapubic pain) with symptoms starting =72 hours prior the study entry.
•Positive pre-treatment clean-catch midstream urine culture (> or =103CFU/ml) and pyuria (10 leukocytes/mm3 or more than 5 leukocytes/field 40x magnification) within the 48 hours prior to inclusion in the study.
•In vitro susceptibility testing of the isolated uropathogen to the drugs under study.
•Written informed consent.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Woman who are pregnant, nursing or not using a medically accepted, effective method of birth control.
•Three or more episodes of uncomplicated acute infections of the urinary tract during the past 12 months.
•Symptoms starting >4 days prior to admission
•Body temperature > 38ºC, back pain, chills or other manifestations suggestive of upper urinary infection.
•Evidence of structural or functional alterations of the urinary tract, such as calculi, stenosis, primary renal disease (eg. polycystic renal disease) or neurogenic bladder.
•Underlying disease predisposing to complicated urinary tract infections such as diabetes mellitus, immunosuppresion, leucopenia, heart insufficiency, liver impairment and neoplasic processes.
•Known or suspected hipersensitivity to the drugs under study.
•Patients having received other antibiotics within the 48 hour period prior to study entry.
•Considered by the investigator as being incapable of following instructions and collaborating during the development of the study

发起方

TEDEC-MEIJI FARMA, S.A.