Efficacy and Safety of Cefditoren Pivoxil Versus Ciprofloxacin in Acute Uncomplicated Cystitis

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The main objective of the study is to comparatively assess the efficacy and tolerability of the drugs under study in the treatment of acute uncomplicated cystitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tedec-Meiji Farma, S.A.
• Treatments: Cefditoren; Cefditoren pivoxil; Cephalosporins; Ciprofloxacin

Criteria

Inclusion Criteria:

• Non-pregnant adult females (>= 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 (>= 103 CFU/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

Exclusion Criteria:

• 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 >= 38.3ºC, 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, immunosuppression, leucopenia, heart insufficiency, liver impairment and neoplastic processes