Multicentre, prospective, comparative, randomized, double-blind, double-dummy study to assess the efficacy and safety of cefditoren pivoxil versus ciprofloxacin in acute uncomplicated cystitis.
- Conditions
- Acute uncomplicated cystitis in non-pregnant women, defined as: a clinical syndrome characterized by dysuria, suprapubic pain, frequency and/or urgency in combination with bacteriuria and pyuria. No renal pathology, urological dysfunction or obstruction is present.MedDRA version: 9.1Level: LLTClassification code 10000699Term: Acute cystitis (excl in pregnancy)
- Registration Number
- EUCTR2007-001486-15-GR
- Lead Sponsor
- TEDEC-MEIJI FARMA, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 580
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
Males.
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of the drugs under study:<br>- Microbiological efficacy (primary efficacy parameter)<br>- Clinical efficacy<br><br>;Secondary Objective: To assess the tolerability of the drugs.;Primary end point(s): The primary endpoint of the study is bacteriological eradication in the per Protocol Population (PP) at the 5-9 days post-therapy visit.
- Secondary Outcome Measures
Name Time Method