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

Sponsor:	Tedec-Meiji Farma, S.A.
Information provided by:	Tedec-Meiji Farma, S.A.
ClinicalTrials.gov Identifier:	NCT00598403

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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 Ciprofloxacin lactate Cefditoren

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 ]

Estimated Enrollment:	580
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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

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

Sponsors and Collaborators

Tedec-Meiji Farma, S.A.

Investigators

Principal Investigator:	Jose L Ballve	Unaffiliated
Principal Investigator:	Josep R Toll	Unaffiliated
Principal Investigator:	Rosa Viñas	Unaffiliated
Principal Investigator:	Rosaura Figueras	Unaffiliated
Principal Investigator:	Joan Palou	Unaffiliated
Principal Investigator:	Gabriel Martín	Unaffiliated
Principal Investigator:	Ramon Pons	Unaffiliated
Principal Investigator:	Manel Terns	Unaffiliated
Principal Investigator:	Josep L Fernandez	Unaffiliated
Principal Investigator:	Pere Toran	Unaffiliated
Principal Investigator:	Pilar Montero	Unaffiliated
Principal Investigator:	Bingen Uriondo	Unaffiliated
Principal Investigator:	Pablo Daza	Unaffiliated
Principal Investigator:	Jesus Zorita	Unaffiliated
Principal Investigator:	Ander Larrazabal	Unaffiliated
Principal Investigator:	Natividad Gonzalez	Unaffiliated
Principal Investigator:	Jose F Magdalena	Unaffiliated
Principal Investigator:	Fernando Martin	Unaffiliated
Principal Investigator:	Jose Porta	Unaffiliated
Principal Investigator:	Mª Rosa Magallon	Unaffiliated
Principal Investigator:	Mª Sol Reixa	Unaffiliated
Principal Investigator:	Jesus Torrecilla	Unaffiliated
Principal Investigator:	Isabel Blasco	Unaffiliated
Principal Investigator:	Antonio Hidalgo	Unaffiliated
Principal Investigator:	Alicia Alvarez	Unaffiliated
Principal Investigator:	Gabriel Romera	Unaffiliated
Principal Investigator:	Estrella Castro	Unaffiliated
Principal Investigator:	Manuel M Ortega	Unaffiliated
Principal Investigator:	Salvador Pertusa	Unaffiliated
Principal Investigator:	Manuel Ramirez	Unaffiliated
Principal Investigator:	Aggelos Pefanis	Unaffiliated
Principal Investigator:	Chatzimouratidis	Unaffiliated
Principal Investigator:	Jose V Vaquer	Unaffiliated
Principal Investigator:	Nicolas Salvador	Unaffiliated
Principal Investigator:	Jose L Pardo	Unaffiliated
Principal Investigator:	Joaquin Aracil	Unaffiliated
Principal Investigator:	Mª Jesus Barreda	Unaffiliated
Principal Investigator:	Artemio Alvarez	Unaffiliated
Principal Investigator:	Vicente Lopez	Unaffiliated
Principal Investigator:	Panagiotis Gargalianos	Unaffiliated
Principal Investigator:	Dolores M Maestre	Unaffiliated

More Information

No publications provided

Responsible Party:	Tedec-Meiji Farma, S.A. ( Mercedes Gimeno/ R&D Director )
Study ID Numbers:	TM-ME1207/311, 2007-001486-15
Study First Received:	January 9, 2008
Last Updated:	November 24, 2009
ClinicalTrials.gov Identifier:	NCT00598403 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

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

Cystitis

Additional relevant MeSH terms:

Anti-Infective Agents
Cephalosporins
Molecular Mechanisms of Pharmacological Action
Urinary Tract Infections
Urinary Bladder Diseases
Cystitis
Enzyme Inhibitors
Infection

Pharmacologic Actions
Cefditoren
Cefditoren pivoxil
Anti-Bacterial Agents
Ciprofloxacin
Urologic Diseases
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010