Efficacy and Safety of Cefditoren Pivoxil Versus Ciprofloxacin in Acute Uncomplicated Cystitis
NCT ID: NCT00598403
Last Updated: 2010-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
611 participants
INTERVENTIONAL
2007-11-30
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Cefditoren pivoxil
cefditoren pivoxil
400 mg, oral, single dose during 3 days
2
Ciprofloxacin
Ciprofloxacin
250 mg, oral, twice a day for 3 days
Interventions
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cefditoren pivoxil
400 mg, oral, single dose during 3 days
Ciprofloxacin
250 mg, oral, twice a day for 3 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Tedec-Meiji Farma, S.A.
INDUSTRY
Responsible Party
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Tedec-Meiji Farma, S.A.
Principal Investigators
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Jose L Ballve
Role: PRINCIPAL_INVESTIGATOR
Josep R Toll
Role: PRINCIPAL_INVESTIGATOR
Rosa Viñas
Role: PRINCIPAL_INVESTIGATOR
Rosaura Figueras
Role: PRINCIPAL_INVESTIGATOR
Joan Palou
Role: PRINCIPAL_INVESTIGATOR
Gabriel Martín
Role: PRINCIPAL_INVESTIGATOR
Ramon Pons
Role: PRINCIPAL_INVESTIGATOR
Manel Terns
Role: PRINCIPAL_INVESTIGATOR
Josep L Fernandez
Role: PRINCIPAL_INVESTIGATOR
Pere Toran
Role: PRINCIPAL_INVESTIGATOR
Pilar Montero
Role: PRINCIPAL_INVESTIGATOR
Bingen Uriondo
Role: PRINCIPAL_INVESTIGATOR
Pablo Daza
Role: PRINCIPAL_INVESTIGATOR
Jesus Zorita
Role: PRINCIPAL_INVESTIGATOR
Ander Larrazabal
Role: PRINCIPAL_INVESTIGATOR
Natividad Gonzalez
Role: PRINCIPAL_INVESTIGATOR
Jose F Magdalena
Role: PRINCIPAL_INVESTIGATOR
Fernando Martin
Role: PRINCIPAL_INVESTIGATOR
Jose Porta
Role: PRINCIPAL_INVESTIGATOR
Mª Rosa Magallon
Role: PRINCIPAL_INVESTIGATOR
Mª Sol Reixa
Role: PRINCIPAL_INVESTIGATOR
Jesus Torrecilla
Role: PRINCIPAL_INVESTIGATOR
Isabel Blasco
Role: PRINCIPAL_INVESTIGATOR
Antonio Hidalgo
Role: PRINCIPAL_INVESTIGATOR
Alicia Alvarez
Role: PRINCIPAL_INVESTIGATOR
Gabriel Romera
Role: PRINCIPAL_INVESTIGATOR
Estrella Castro
Role: PRINCIPAL_INVESTIGATOR
Manuel M Ortega
Role: PRINCIPAL_INVESTIGATOR
Salvador Pertusa
Role: PRINCIPAL_INVESTIGATOR
Manuel Ramirez
Role: PRINCIPAL_INVESTIGATOR
Aggelos Pefanis
Role: PRINCIPAL_INVESTIGATOR
Chatzimouratidis
Role: PRINCIPAL_INVESTIGATOR
Jose V Vaquer
Role: PRINCIPAL_INVESTIGATOR
Nicolas Salvador
Role: PRINCIPAL_INVESTIGATOR
Jose L Pardo
Role: PRINCIPAL_INVESTIGATOR
Joaquin Aracil
Role: PRINCIPAL_INVESTIGATOR
Mª Jesus Barreda
Role: PRINCIPAL_INVESTIGATOR
Artemio Alvarez
Role: PRINCIPAL_INVESTIGATOR
Vicente Lopez
Role: PRINCIPAL_INVESTIGATOR
Panagiotis Gargalianos
Role: PRINCIPAL_INVESTIGATOR
Dolores M Maestre
Role: PRINCIPAL_INVESTIGATOR
Locations
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General Hospital of Chest Disease of Athens
Athens, , Greece
General Hospital of Thessaloniki
Thessaloniki, , Greece
CS Rincón de Loix
Benidorm, Alicante, Spain
CAP Cornella
Cornellà de Llobregat, Barcelona, Spain
CAP 17 setembre
el Prat de Llobregat, Barcelona, Spain
CAP Bartomeu Fabres Anglada
Gavà, Barcelona, Spain
CAP Amadeu Torner
L'Hospitalet de Llobregat, Barcelona, Spain
CAP Florida Nord
L'Hospitalet de Llobregat, Barcelona, Spain
CAP Dr. Vicens Papaceit
La Roca del Vallès, Barcelona, Spain
CAP Les Bases-Manresa 3
Manresa, Barcelona, Spain
CAP La Riera
Mataró, Barcelona, Spain
CAP El Maresme
Mataró, Barcelona, Spain
CAP Navas-Balsareny
Navàs, Barcelona, Spain
CAP Remei
Vic, Barcelona, Spain
CS San Telmo
Jerez de la Frontera, Cadiz, Spain
CS Cabra
Cabra, Cordoba, Spain
CS Lucena
Lucena, Cordoba, Spain
CS Rute
Rute, Cordoba, Spain
CS Billabona
Billabona, Guipuzcoa, Spain
CS Legazpi
Legazpi, Guipuzcoa, Spain
CS Monzón Urbano
Monzón, Huesca, Spain
CS Basurto
Bilbao, Vizcaya, Spain
CS Cabo Huertas
Alicante, , Spain
CAP El Clot
Barcelona, , Spain
Fundacion Puigvert
Barcelona, , Spain
CS Sagasta Ruiseñores
Zaragoza, , Spain
CS Torrero La Paz
Zaragoza, , Spain
CS Torre Ramona
Zaragoza, , Spain
CS Arrabal
Zaragoza, , Spain
CS Bombarda
Zaragoza, , Spain
Countries
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Other Identifiers
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2007-001486-15
Identifier Type: -
Identifier Source: secondary_id
TM-ME1207/311
Identifier Type: -
Identifier Source: org_study_id
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