Efficacy and Safety of Cefditoren Pivoxil Versus Ciprofloxacin in Acute Uncomplicated Cystitis
- Conditions
- Urinary Tract Infections
- Interventions
- Registration Number
- NCT00598403
- Lead Sponsor
- Tedec-Meiji Farma, S.A.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 611
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 cefditoren pivoxil Cefditoren pivoxil 2 Ciprofloxacin Ciprofloxacin
- Primary Outcome Measures
Name Time Method Microbiological efficacy 5-9 days post-therapy
- Secondary Outcome Measures
Name Time Method Clinical efficacy 5-9 days post-therapy
Trial Locations
- Locations (30)
CAP Remei
🇪🇸Vic, Barcelona, Spain
CAP Florida Nord
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
CS Basurto
🇪🇸Bilbao, Vizcaya, Spain
CAP Cornella
🇪🇸Cornella de Llobregat, Barcelona, Spain
CAP 17 setembre
🇪🇸El Prat de Llobregat, Barcelona, Spain
CAP Dr. Vicens Papaceit
🇪🇸La Roca del Valles, Barcelona, Spain
CS Torre Ramona
🇪🇸Zaragoza, Spain
CAP Les Bases-Manresa 3
🇪🇸Manresa, Barcelona, Spain
General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
CAP Bartomeu Fabres Anglada
🇪🇸Gava, Barcelona, Spain
CS Lucena
🇪🇸Lucena, Cordoba, Spain
CAP Amadeu Torner
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
CAP La Riera
🇪🇸Mataro, Barcelona, Spain
CAP El Maresme
🇪🇸Mataro, Barcelona, Spain
General Hospital of Chest Disease of Athens
🇬🇷Athens, Greece
CS Rincón de Loix
🇪🇸Benidorm, Alicante, Spain
CS San Telmo
🇪🇸Jerez de la frontera, Cadiz, Spain
CS Arrabal
🇪🇸Zaragoza, Spain
CAP Navas-Balsareny
🇪🇸Navas, Barcelona, Spain
CS Billabona
🇪🇸Billabona, Guipuzcoa, Spain
CS Legazpi
🇪🇸Legazpi, Guipuzcoa, Spain
CS Rute
🇪🇸Rute, Cordoba, Spain
CAP El Clot
🇪🇸Barcelona, Spain
CS Cabo Huertas
🇪🇸Alicante, Spain
CS Monzón Urbano
🇪🇸Monzon, Huesca, Spain
CS Sagasta Ruiseñores
🇪🇸Zaragoza, Spain
Fundacion Puigvert
🇪🇸Barcelona, Spain
CS Torrero La Paz
🇪🇸Zaragoza, Spain
CS Bombarda
🇪🇸Zaragoza, Spain
CS Cabra
🇪🇸Cabra, Cordoba, Spain