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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Drug: cefditoren pivoxil; Drug: Ciprofloxacin

Detailed Description

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 Type: Interventional
• Enrollment (Actual): 611
• Phase: Phase 3

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • General Hospital of Chest Disease of Athens
  • Thessaloniki, Greece
    • General Hospital of Thessaloniki
• Spain
  • Alicante, Spain, 03540
    • CS Cabo Huertas
  • Barcelona, Spain, 08025
    • Fundacion Puigvert
  • Barcelona, Spain, 08018
    • CAP El Clot
  • Zaragoza, Spain, 50006
    • CS Sagasta Ruiseñores
  • Zaragoza, Spain, 50007
    • CS Torrero La Paz
  • Zaragoza, Spain, 50013
    • CS Torre Ramona
  • Zaragoza, Spain, 50015
    • CS Arrabal
  • Zaragoza, Spain, 50017
    • CS Bombarda
  • Alicante
    • Benidorm, Alicante, Spain, 03500
      • CS Rincón de Loix
  • Barcelona
    • Cornella de Llobregat, Barcelona, Spain, 08940
      • CAP Cornella
    • El Prat de Llobregat, Barcelona, Spain, 08820
      • CAP 17 setembre
    • Gava, Barcelona, Spain, 08850
      • CAP Bartomeu Fabres Anglada
    • Hospitalet de Llobregat, Barcelona, Spain, 08902
      • CAP Amadeu Torner
    • Hospitalet de Llobregat, Barcelona, Spain, 08905
      • CAP Florida Nord
    • La Roca del Valles, Barcelona, Spain, 08430
      • CAP Dr. Vicens Papaceit
    • Manresa, Barcelona, Spain, 08243
      • CAP Les Bases-Manresa 3
    • Mataro, Barcelona, Spain, 08302
      • CAP La Riera
    • Mataro, Barcelona, Spain, 08303
      • CAP El Maresme
    • Navas, Barcelona, Spain, 08670
      • CAP Navas-Balsareny
    • Vic, Barcelona, Spain, 08500
      • CAP Remei
  • Cadiz
    • Jerez de la frontera, Cadiz, Spain, 11408
      • CS San Telmo
  • Cordoba
    • Cabra, Cordoba, Spain, 14940
      • CS Cabra
    • Lucena, Cordoba, Spain, 14900
      • CS Lucena
    • Rute, Cordoba, Spain, 14960
      • CS Rute
  • Guipuzcoa
    • Billabona, Guipuzcoa, Spain, 20150
      • CS Billabona
    • Legazpi, Guipuzcoa, Spain, 20230
      • CS Legazpi
  • Huesca
    • Monzon, Huesca, Spain, 22400
      • CS Monzón Urbano
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • CS Basurto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Cefditoren pivoxil	Drug: cefditoren pivoxil; 400 mg, oral, single dose during 3 days; Other Names: Meiact, Spectracef, Telo
Active Comparator: 2; Ciprofloxacin	Drug: Ciprofloxacin; 250 mg, oral, twice a day for 3 days; Other Names: Ciprofloxacino Mabo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Microbiological efficacy	5-9 days post-therapy

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical efficacy	5-9 days post-therapy

Collaborators and Investigators

• Sponsor: Tedec-Meiji Farma, S.A.
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: January 9, 2008
• First Submitted That Met QC Criteria: January 9, 2008
• First Posted (Estimate): January 21, 2008

Study Record Updates

• Last Update Posted (Estimate): June 29, 2010
• Last Update Submitted That Met QC Criteria: June 28, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Cystitis
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Bladder Diseases; Cystitis; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin; Cefditoren pivoxil; Cefditoren
• Other Study ID Numbers: TM-ME1207/311; 2007-001486-15