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

This study has been completed.
Sponsor:
Information provided by:
Tedec-Meiji Farma, S.A.
ClinicalTrials.gov Identifier:
NCT00598403
First received: January 9, 2008
Last updated: June 28, 2010
Last verified: June 2010

January 9, 2008
June 28, 2010
November 2007
December 2009   (final data collection date for primary outcome measure)
Microbiological efficacy [ Time Frame: 5-9 days post-therapy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00598403 on ClinicalTrials.gov Archive Site
Clinical efficacy [ Time Frame: 5-9 days post-therapy ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Urinary Tract Infections
  • Drug: cefditoren pivoxil
    400 mg, oral, single dose during 3 days
    Other Name: Meiact, Spectracef, Telo
  • Drug: Ciprofloxacin
    250 mg, oral, twice a day for 3 days
    Other Name: Ciprofloxacino Mabo
  • Experimental: 1
    Cefditoren pivoxil
    Intervention: Drug: cefditoren pivoxil
  • Active Comparator: 2
    Ciprofloxacin
    Intervention: Drug: Ciprofloxacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
611
June 2010
December 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Greece,   Spain
 
NCT00598403
TM-ME1207/311, 2007-001486-15
No
Mercedes Gimeno/ R&D Director, Tedec-Meiji Farma, S.A.
Tedec-Meiji Farma, S.A.
Not Provided
Principal Investigator: Jose L Ballve
Principal Investigator: Josep R Toll
Principal Investigator: Rosa Viñas
Principal Investigator: Rosaura Figueras
Principal Investigator: Joan Palou
Principal Investigator: Gabriel Martín
Principal Investigator: Ramon Pons
Principal Investigator: Manel Terns
Principal Investigator: Josep L Fernandez
Principal Investigator: Pere Toran
Principal Investigator: Pilar Montero
Principal Investigator: Bingen Uriondo
Principal Investigator: Pablo Daza
Principal Investigator: Jesus Zorita
Principal Investigator: Ander Larrazabal
Principal Investigator: Natividad Gonzalez
Principal Investigator: Jose F Magdalena
Principal Investigator: Fernando Martin
Principal Investigator: Jose Porta
Principal Investigator: Mª Rosa Magallon
Principal Investigator: Mª Sol Reixa
Principal Investigator: Jesus Torrecilla
Principal Investigator: Isabel Blasco
Principal Investigator: Antonio Hidalgo
Principal Investigator: Alicia Alvarez
Principal Investigator: Gabriel Romera
Principal Investigator: Estrella Castro
Principal Investigator: Manuel M Ortega
Principal Investigator: Salvador Pertusa
Principal Investigator: Manuel Ramirez
Principal Investigator: Aggelos Pefanis
Principal Investigator: Chatzimouratidis
Principal Investigator: Jose V Vaquer
Principal Investigator: Nicolas Salvador
Principal Investigator: Jose L Pardo
Principal Investigator: Joaquin Aracil
Principal Investigator: Mª Jesus Barreda
Principal Investigator: Artemio Alvarez
Principal Investigator: Vicente Lopez
Principal Investigator: Panagiotis Gargalianos
Principal Investigator: Dolores M Maestre
Tedec-Meiji Farma, S.A.
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP