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

Sponsored by:	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

MedlinePlus related topics: Urinary Tract Infections

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Cefditoren

U.S. FDA Resources

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

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:	June 2009
Estimated Primary Completion Date:	April 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

Contacts

Contact: Patricia Rebollo

0034 91 708 12 79

patricia.rebollo@pivotal.es

Locations

Greece
General Hospital of Chest Disease of Athens	Recruiting
Athens, Greece
Principal Investigator: Aggelos Pefanis
General Hospital of Thessaloniki	Recruiting
Thessaloniki, Greece
Principal Investigator: Chatzimouratidis
Spain
Fundacion Puigvert	Recruiting
Barcelona, Spain, 08025
Principal Investigator: Joan Palou
CS Sagasta Ruiseñores	Recruiting
Zaragoza, Spain, 50006
Principal Investigator: Jose Porta
CS Torre Ramona	Recruiting
Zaragoza, Spain, 50013
Principal Investigator: Natividad Gonzalez
Principal Investigator: Jose F Magdalena
Principal Investigator: Luis Otegui
CS Torrero La Paz	Recruiting
Zaragoza, Spain, 50007
Principal Investigator: Fernando Martin
CAP El Clot	Recruiting
Barcelona, Spain, 08018
Principal Investigator: Joan Bayo
CS Arrabal	Recruiting
Zaragoza, Spain, 50015
Principal Investigator: Mª Rosa Magallon
Principal Investigator: Mª Sol Reixa
CS Bombarda	Recruiting
Zaragoza, Spain, 50017
Principal Investigator: Jesus Torrecilla
CS Cabo Huertas	Recruiting
Alicante, Spain, 03540
Principal Investigator: Salvador Partusa
Spain, Alicante
CS Rincón de Loix	Recruiting
Benidorm, Alicante, Spain, 03500
Principal Investigator: Manuel Ramirez
Spain, Barcelona
CAP 17 setembre	Recruiting
El Prat de Llobregat, Barcelona, Spain, 08820
Principal Investigator: Rosaura Figueras
CAP Cornella	Recruiting
Cornella de Llobregat, Barcelona, Spain, 08940
Principal Investigator: Josep R Toll
CAP Amadeu Torner	Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08902
Principal Investigator: Rosa Viñas
CAP Florida Nord	Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08905
Principal Investigator: Jose L Ballve
CAP Bartomeu Fabres Anglada	Recruiting
Gava, Barcelona, Spain, 08850
Principal Investigator: Estibaliz Redondo
CAP Navas-Balsareny	Recruiting
Navas, Barcelona, Spain, 08670
Principal Investigator: Gabriel Martin
CAP Les Bases-Manresa 3	Recruiting
Manresa, Barcelona, Spain, 08243
Principal Investigator: Ramon Pons
CAP Remei	Recruiting
Vic, Barcelona, Spain, 08500
Principal Investigator: Manel Terns
CAP Dr. Vicens Papaceit	Recruiting
La Roca del Valles, Barcelona, Spain, 08430
Principal Investigator: Josep L Fernandez
CAP El Maresme	Recruiting
Mataro, Barcelona, Spain, 08303
Principal Investigator: Pere Toran
CAP La Riera	Recruiting
Mataro, Barcelona, Spain, 08302
Principal Investigator: Pilar Montero
Spain, Cadiz
CS San Telmo	Recruiting
Jerez de la frontera, Cadiz, Spain, 11408
Principal Investigator: Manuel M Ortega
Spain, Cordoba
CS Lucena	Recruiting
Lucena, Cordoba, Spain, 14900
Principal Investigator: Antonio Hidalgo
Principal Investigator: Alicia Alvarez
Principal Investigator: Gabriel Romera
CS Rute	Recruiting
Rute, Cordoba, Spain, 14960
Principal Investigator: Estrella Castro
CS Cabra	Recruiting
Cabra, Cordoba, Spain, 14940
Principal Investigator: Mª Dolores Maestre
Spain, Guipuzcoa
CS Legazpi	Recruiting
Legazpi, Guipuzcoa, Spain, 20230
Principal Investigator: Bingen Uriondo
CS Billabona	Recruiting
Billabona, Guipuzcoa, Spain, 20150
Principal Investigator: Pablo Daza
Spain, Huesca
CS Monzón Urbano	Recruiting
Monzon, Huesca, Spain, 22400
Principal Investigator: Isabel Blasco
Spain, Vizcaya
CS Basurto	Recruiting
Bilbao, Vizcaya, Spain, 48013
Principal Investigator: Ander Larrazabal
Principal Investigator: Jesus Zorita

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:	Estibaliz Redondo	Unaffiliated
Principal Investigator:	Gabriel Martín	Unaffiliated
Principal Investigator:	Ramon Pons	Unaffiliated
Principal Investigator:	Manel Terns	Unaffiliated
Principal Investigator:	Josep L Fernandez	Unaffiliated
Principal Investigator:	Joan Bayo	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:	Luis Otegui	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

More Information

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:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00598403
Health Authority:	Spain: Spanish Agency of Medicines

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

Cystitis

Study placed in the following topic categories:

Cefditoren pivoxil
Cephalosporins
Ciprofloxacin
Cystocele
Urologic Diseases

Cefixime
Urinary Bladder Diseases
Urinary Tract Infections
Cystitis
Cefditoren

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Infection
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009