Efficacy and Safety of Cefditoren Pivoxil Versus Ciprofloxacin in Acute Uncomplicated Cystitis
Information source: Tedec-Meiji Farma, S.A.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Tract Infections
Intervention: cefditoren pivoxil (Drug); Ciprofloxacin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Tedec-Meiji Farma, S.A. Official(s) and/or principal investigator(s):
Jose L Ballve, Principal Investigator, Affiliation: Unaffiliated
Josep R Toll, Principal Investigator, Affiliation: Unaffiliated
Rosa Viñas, Principal Investigator, Affiliation: Unaffiliated
Rosaura Figueras, Principal Investigator, Affiliation: Unaffiliated
Joan Palou, Principal Investigator, Affiliation: Unaffiliated
Gabriel Martín, Principal Investigator, Affiliation: Unaffiliated
Ramon Pons, Principal Investigator, Affiliation: Unaffiliated
Manel Terns, Principal Investigator, Affiliation: Unaffiliated
Josep L Fernandez, Principal Investigator, Affiliation: Unaffiliated
Pere Toran, Principal Investigator, Affiliation: Unaffiliated
Pilar Montero, Principal Investigator, Affiliation: Unaffiliated
Bingen Uriondo, Principal Investigator, Affiliation: Unaffiliated
Pablo Daza, Principal Investigator, Affiliation: Unaffiliated
Jesus Zorita, Principal Investigator, Affiliation: Unaffiliated
Ander Larrazabal, Principal Investigator, Affiliation: Unaffiliated
Natividad Gonzalez, Principal Investigator, Affiliation: Unaffiliated
Jose F Magdalena, Principal Investigator, Affiliation: Unaffiliated
Fernando Martin, Principal Investigator, Affiliation: Unaffiliated
Jose Porta, Principal Investigator, Affiliation: Unaffiliated
Mª Rosa Magallon, Principal Investigator, Affiliation: Unaffiliated
Mª Sol Reixa, Principal Investigator, Affiliation: Unaffiliated
Jesus Torrecilla, Principal Investigator, Affiliation: Unaffiliated
Isabel Blasco, Principal Investigator, Affiliation: Unaffiliated
Antonio Hidalgo, Principal Investigator, Affiliation: Unaffiliated
Alicia Alvarez, Principal Investigator, Affiliation: Unaffiliated
Gabriel Romera, Principal Investigator, Affiliation: Unaffiliated
Estrella Castro, Principal Investigator, Affiliation: Unaffiliated
Manuel M Ortega, Principal Investigator, Affiliation: Unaffiliated
Salvador Pertusa, Principal Investigator, Affiliation: Unaffiliated
Manuel Ramirez, Principal Investigator, Affiliation: Unaffiliated
Aggelos Pefanis, Principal Investigator, Affiliation: Unaffiliated
Chatzimouratidis, Principal Investigator, Affiliation: Unaffiliated
Jose V Vaquer, Principal Investigator, Affiliation: Unaffiliated
Nicolas Salvador, Principal Investigator, Affiliation: Unaffiliated
Jose L Pardo, Principal Investigator, Affiliation: Unaffiliated
Joaquin Aracil, Principal Investigator, Affiliation: Unaffiliated
Mª Jesus Barreda, Principal Investigator, Affiliation: Unaffiliated
Artemio Alvarez, Principal Investigator, Affiliation: Unaffiliated
Vicente Lopez, Principal Investigator, Affiliation: Unaffiliated
Panagiotis Gargalianos, Principal Investigator, Affiliation: Unaffiliated
Dolores M Maestre, Principal Investigator, Affiliation: Unaffiliated
Overall contact:
Mercedes Gimeno, Phone: 0034 91 887 09 80, Email: m.gimeno@tedecmeiji.com
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Microbiological efficacy
Secondary outcome: Clinical efficacy
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Mercedes Gimeno, Phone: 0034 91 887 09 80, Email: m.gimeno@tedecmeiji.com
General Hospital of Chest Disease of Athens, Athens, Greece; Recruiting
Aggelos Pefanis, Principal Investigator
General Hospital of Thessaloniki, Thessaloniki, Greece; Recruiting
Chatzimouratidis, Principal Investigator
Fundacion Puigvert, Barcelona 08025, Spain; Recruiting
Joan Palou, Principal Investigator
CAP El Clot, Barcelona 08018, Spain; Recruiting
Joan Bayo, Principal Investigator
CS Torre Ramona, Zaragoza 50013, Spain; Recruiting
Natividad Gonzalez, Principal Investigator
Jose F Magdalena, Principal Investigator
Luis Otegui, Principal Investigator
CS Torrero La Paz, Zaragoza 50007, Spain; Recruiting
Fernando Martin, Principal Investigator
CS Sagasta Ruiseñores, Zaragoza 50006, Spain; Recruiting
Jose Porta, Principal Investigator
CS Arrabal, Zaragoza 50015, Spain; Recruiting
Mª Rosa Magallon, Principal Investigator
Mª Sol Reixa, Principal Investigator
CS Bombarda, Zaragoza 50017, Spain; Recruiting
Jesus Torrecilla, Principal Investigator
CS Cabo Huertas, Alicante 03540, Spain; Recruiting
Salvador Partusa, Principal Investigator
CS Rincón de Loix, Benidorm, Alicante 03500, Spain; Recruiting
Manuel Ramirez, Principal Investigator
CAP Florida Nord, Hospitalet de Llobregat, Barcelona 08905, Spain; Recruiting
Jose L Ballve, Principal Investigator
CAP Cornella, Cornella de Llobregat, Barcelona 08940, Spain; Recruiting
Josep R Toll, Principal Investigator
CAP Amadeu Torner, Hospitalet de Llobregat, Barcelona 08902, Spain; Recruiting
Rosa Viñas, Principal Investigator
CAP 17 setembre, El Prat de Llobregat, Barcelona 08820, Spain; Recruiting
Rosaura Figueras, Principal Investigator
CAP Bartomeu Fabres Anglada, Gava, Barcelona 08850, Spain; Recruiting
Estibaliz Redondo, Principal Investigator
CAP Navas-Balsareny, Navas, Barcelona 08670, Spain; Recruiting
Gabriel Martin, Principal Investigator
CAP Les Bases-Manresa 3, Manresa, Barcelona 08243, Spain; Recruiting
Ramon Pons, Principal Investigator
CAP Remei, Vic, Barcelona 08500, Spain; Recruiting
Manel Terns, Principal Investigator
CAP Dr. Vicens Papaceit, La Roca del Valles, Barcelona 08430, Spain; Recruiting
Josep L Fernandez, Principal Investigator
CAP El Maresme, Mataro, Barcelona 08303, Spain; Recruiting
Pere Toran, Principal Investigator
CAP La Riera, Mataro, Barcelona 08302, Spain; Recruiting
Pilar Montero, Principal Investigator
CS San Telmo, Jerez de la frontera, Cadiz 11408, Spain; Recruiting
Manuel M Ortega, Principal Investigator
CS Lucena, Lucena, Cordoba 14900, Spain; Recruiting
Antonio Hidalgo, Principal Investigator
Alicia Alvarez, Principal Investigator
Gabriel Romera, Principal Investigator
CS Rute, Rute, Cordoba 14960, Spain; Recruiting
Estrella Castro, Principal Investigator
CS Cabra, Cabra, Cordoba 14940, Spain; Recruiting
Mª Dolores Maestre, Principal Investigator
CS Legazpi, Legazpi, Guipuzcoa 20230, Spain; Recruiting
Bingen Uriondo, Principal Investigator
CS Billabona, Billabona, Guipuzcoa 20150, Spain; Recruiting
Pablo Daza, Principal Investigator
CS Monzón Urbano, Monzon, Huesca 22400, Spain; Recruiting
Isabel Blasco, Principal Investigator
CS Basurto, Bilbao, Vizcaya 48013, Spain; Recruiting
Ander Larrazabal, Principal Investigator
Jesus Zorita, Principal Investigator
Additional Information
Starting date: November 2007
Ending date: June 2009
Last updated: June 3, 2009
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