Efficacy and Safety of Cefditoren Pivoxil Versus Ciprofloxacin in Acute Uncomplicated Cystitis

Phase 3

Completed

• Conditions: Urinary Tract Infections
• Interventions: Drug: cefditoren pivoxil; Drug: Ciprofloxacin

• 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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-01-09
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-21
• Primary Completion: 2009-12
• Status Verified: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2010-06-28
• Last Update Posted: 2010-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 611

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

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