Efficacy and Safety of Cefditoren Pivoxil Versus Ciprofloxacin in Acute Uncomplicated Cystitis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Urinary Tract Infections	Drug: cefditoren pivoxil Drug: Ciprofloxacin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Multicentre, Prospective, Comparative, Randomized, Double-blind, Double-dummy Study to Assess the Efficacy and Safety of Cefditoren Pivoxil vs. Ciprofloxacin in Uncomplicated Acute Cystitis

Resource links provided by NLM:

MedlinePlus related topics: Urinary Tract Infections

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Cefditoren Cefditoren Pivoxil

U.S. FDA Resources

Further study details as provided by Tedec-Meiji Farma, S.A.:

Primary Outcome Measures:

Microbiological efficacy [ Time Frame: 5-9 days post-therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical efficacy [ Time Frame: 5-9 days post-therapy ] [ Designated as safety issue: No ]

Enrollment:	611
Study Start Date:	November 2007
Study Completion Date:	June 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Cefditoren pivoxil	Drug: cefditoren pivoxil 400 mg, oral, single dose during 3 days Other Name: Meiact, Spectracef, Telo
Active Comparator: 2 Ciprofloxacin	Drug: Ciprofloxacin 250 mg, oral, twice a day for 3 days Other Name: Ciprofloxacino Mabo

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598403

Locations

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

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	Mercedes Gimeno/ R&D Director, Tedec-Meiji Farma, S.A.
ClinicalTrials.gov Identifier:	NCT00598403 History of Changes
Other Study ID Numbers:	TM-ME1207/311, 2007-001486-15
Study First Received:	January 9, 2008
Last Updated:	June 28, 2010
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Tedec-Meiji Farma, S.A.:

Cystitis

Additional relevant MeSH terms:

Cystitis
Urinary Tract Infections
Urinary Bladder Diseases
Urologic Diseases
Infection
Ciprofloxacin
Cefditoren pivoxil
Cefditoren

Cephalosporins
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013