Clinical trial NCT00598403: Efficacy and Safety of Cefditoren Pivoxil Versus Ciprofloxacin in Acute Uncomplicated Cystitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Tract Infections
Keywords: Cystitis
Lead sponsor: Tedec-Meiji Farma, S.A.
Sponsor class: INDUSTRY
First posted: 2008-01-21
Enrollment: 611
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Microbiological efficacy
timeFrame: 5-9 days post-therapy
Secondary outcomes:
measure: Clinical efficacy
timeFrame: 5-9 days post-therapy
Other outcomes:
Locations:
city: Athens
country: Greece
facility: General Hospital of Chest Disease of Athens
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki
city: Benidorm
country: Spain
facility: CS Rincón de Loix
state: Alicante
city: Cornella de Llobregat
country: Spain
facility: CAP Cornella
state: Barcelona
city: El Prat de Llobregat
country: Spain
facility: CAP 17 setembre
state: Barcelona
city: Gava
country: Spain
facility: CAP Bartomeu Fabres Anglada
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: CAP Amadeu Torner
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: CAP Florida Nord
state: Barcelona
city: La Roca del Valles
country: Spain
facility: CAP Dr. Vicens Papaceit
state: Barcelona
city: Manresa
country: Spain
facility: CAP Les Bases-Manresa 3
state: Barcelona
city: Mataro
country: Spain
facility: CAP La Riera
state: Barcelona
city: Mataro
country: Spain
facility: CAP El Maresme
state: Barcelona
city: Navas
country: Spain
facility: CAP Navas-Balsareny
state: Barcelona
city: Vic
country: Spain
facility: CAP Remei
state: Barcelona
city: Jerez de la frontera
country: Spain
facility: CS San Telmo
state: Cadiz
city: Cabra
country: Spain
facility: CS Cabra
state: Cordoba
city: Lucena
country: Spain
facility: CS Lucena
state: Cordoba
city: Rute
country: Spain
facility: CS Rute
state: Cordoba
city: Billabona
country: Spain
facility: CS Billabona
state: Guipuzcoa
city: Legazpi
country: Spain
facility: CS Legazpi
state: Guipuzcoa
city: Monzon
country: Spain
facility: CS Monzón Urbano
state: Huesca
city: Bilbao
country: Spain
facility: CS Basurto
state: Vizcaya
city: Alicante
country: Spain
facility: CS Cabo Huertas
city: Barcelona
country: Spain
facility: CAP El Clot
city: Barcelona
country: Spain
facility: Fundacion Puigvert
city: Zaragoza
country: Spain
facility: CS Sagasta Ruiseñores
city: Zaragoza
country: Spain
facility: CS Torrero La Paz
city: Zaragoza
country: Spain
facility: CS Torre Ramona
city: Zaragoza
country: Spain
facility: CS Arrabal
city: Zaragoza
country: Spain
facility: CS Bombarda
Study officials:
name: Jose L Ballve
role: PRINCIPAL_INVESTIGATOR
name: Josep R Toll
role: PRINCIPAL_INVESTIGATOR
name: Rosa Viñas
role: PRINCIPAL_INVESTIGATOR
name: Rosaura Figueras
role: PRINCIPAL_INVESTIGATOR
name: Joan Palou
role: PRINCIPAL_INVESTIGATOR
name: Gabriel Martín
role: PRINCIPAL_INVESTIGATOR
name: Ramon Pons
role: PRINCIPAL_INVESTIGATOR
name: Manel Terns
role: PRINCIPAL_INVESTIGATOR
name: Josep L Fernandez
role: PRINCIPAL_INVESTIGATOR
name: Pere Toran
role: PRINCIPAL_INVESTIGATOR
name: Pilar Montero
role: PRINCIPAL_INVESTIGATOR
name: Bingen Uriondo
role: PRINCIPAL_INVESTIGATOR
name: Pablo Daza
role: PRINCIPAL_INVESTIGATOR
name: Jesus Zorita
role: PRINCIPAL_INVESTIGATOR
name: Ander Larrazabal
role: PRINCIPAL_INVESTIGATOR
name: Natividad Gonzalez
role: PRINCIPAL_INVESTIGATOR
name: Jose F Magdalena
role: PRINCIPAL_INVESTIGATOR
name: Fernando Martin
role: PRINCIPAL_INVESTIGATOR
name: Jose Porta
role: PRINCIPAL_INVESTIGATOR
name: Mª Rosa Magallon
role: PRINCIPAL_INVESTIGATOR
name: Mª Sol Reixa
role: PRINCIPAL_INVESTIGATOR
name: Jesus Torrecilla
role: PRINCIPAL_INVESTIGATOR
name: Isabel Blasco
role: PRINCIPAL_INVESTIGATOR
name: Antonio Hidalgo
role: PRINCIPAL_INVESTIGATOR
name: Alicia Alvarez
role: PRINCIPAL_INVESTIGATOR
name: Gabriel Romera
role: PRINCIPAL_INVESTIGATOR
name: Estrella Castro
role: PRINCIPAL_INVESTIGATOR
name: Manuel M Ortega
role: PRINCIPAL_INVESTIGATOR
name: Salvador Pertusa
role: PRINCIPAL_INVESTIGATOR
name: Manuel Ramirez
role: PRINCIPAL_INVESTIGATOR
name: Aggelos Pefanis
role: PRINCIPAL_INVESTIGATOR
name: Chatzimouratidis
role: PRINCIPAL_INVESTIGATOR
name: Jose V Vaquer
role: PRINCIPAL_INVESTIGATOR
name: Nicolas Salvador
role: PRINCIPAL_INVESTIGATOR
name: Jose L Pardo
role: PRINCIPAL_INVESTIGATOR
name: Joaquin Aracil
role: PRINCIPAL_INVESTIGATOR
name: Mª Jesus Barreda
role: PRINCIPAL_INVESTIGATOR
name: Artemio Alvarez
role: PRINCIPAL_INVESTIGATOR
name: Vicente Lopez
role: PRINCIPAL_INVESTIGATOR
name: Panagiotis Gargalianos
role: PRINCIPAL_INVESTIGATOR
name: Dolores M Maestre
role: PRINCIPAL_INVESTIGATOR
References: