Trial | NCT00598403  Report issue

Title

Efficacy and Safety of Cefditoren Pivoxil Versus Ciprofloxacin in Acute Uncomplicated Cystitis
Multicentre, Prospective, Comparative, Randomized, Double-blind, Double-dummy Study to Assess the Efficacy and Safety of Cefditoren Pivoxil vs. Ciprofloxacin in Uncomplicated Acute Cystitis

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    611
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.
Study Started
Nov 30
2007
Primary Completion
Dec 31
2009
Study Completion
Jun 30
2010
Last Update
Jun 29
2010
Estimate

Drug cefditoren pivoxil

400 mg, oral, single dose during 3 days

  • Other names: Meiact, Spectracef, Telo

Drug Ciprofloxacin

250 mg, oral, twice a day for 3 days

  • Other names: Ciprofloxacino Mabo

1 Experimental

Cefditoren pivoxil

2 Active Comparator

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
No Results Posted