Efficacy and Safety of Cefditoren Pivoxil Versus Ciprofloxacin in Acute Uncomplicated Cystitis
Efficacy and Safety of Cefditoren Pivoxil Versus Ciprofloxacin in Acute Uncomplicated Cystitis
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.
Urinary tract infections (UTI) are one of the most frequent reasons of surgery visits in
 Primary Care. More than 95 percent of UTIs are monomicrobial, although the microorganisms
 implied are varied, and the range of effective drugs could be extensive. The species most
 frequently isolated is Escherichia coli, with prevalence ranking between 85 and 90 percent of
 documented cases. E. coli has developed resistance to different antibiotics. Cefditoren is
 situated as a good candidate for the treatment of uncomplicated UTIs due to its spectrum of
 activity against E. coli. The study has been designed in accordance with the guidelines and
 recommendations in force to assess the efficacy of cefditoren pivoxil against ciprofloxacin,
 a drug which despite the increasing rate of resistance in some countries, continues to be a
 drug of choice for the treatment of uncomplicated UTIs.
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