Multicentre, prospective, comparative, randomized, double-blind, double-dummy study to assess the efficacy and safety of cefditoren pivoxil versus ciprofloxacin in acute uncomplicated cystitis.Estudio multicéntrico, prospectivo, comparativo, aleatorizado, doble ciego y doble enmascarado para evaluar la eficacia y seguridad de cefditoren pivoxilo vs. ciprofloxacino en cistitis aguda no complicada.

Active, not recruiting

• Conditions: Cistitis aguda no complicada en mujeres no embarazadas: patología caracterizada por disuria, dolor suprapúbico, polaquiuria y/o tenesmo en combinación con bacteriuria y piuria. Sin patología renal asociada, disfunción urológica u obstrucción.Acute uncomplicated cystitis in non-pregnant women: pathology 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-ES
• Lead Sponsor: TEDEC-MEIJI FARMA, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-02
• Last Update Posted: 2012-04-18

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Female
• Target Recruitment: 580

Inclusion Criteria

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

Exclusion Criteria

Males.
Pregnancy or lactation.
Three or more episodes of uncomplicated acute infections of the urinary tract during the past 12 months.
Symptoms starting >=96 hours prior to admission
Body temperature >= 38.3ºC, back pain, chills or other manifestations suggestive of upper urinary infection.
Structural or functional alterations of the urinary tract (calculi, stenosis, primary renal disease, neurogenic bladder).
Underlying disease predisposing to complicated urinary tract infections (diabetes mellitus, immunosuppresion, leucopenia, heart insufficiency, liver impairment and neoplasic processes).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified