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

Urinary Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598403
• Other study ID #: TM-ME1207/311
• Secondary ID: 2007-001486-15
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2008
• Last updated: June 28, 2010
• Start date: November 2007
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: Tedec-Meiji Farma, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 611
• Est. completion date: June 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Urinary Tract Infections

Intervention

Drug:
• cefditoren pivoxil
400 mg, oral, single dose during 3 days
• Ciprofloxacin
250 mg, oral, twice a day for 3 days

Locations

Country	Name	City	State
Greece	General Hospital of Chest Disease of Athens	Athens
Greece	General Hospital of Thessaloniki	Thessaloniki
Spain	CS Cabo Huertas	Alicante
Spain	CAP El Clot	Barcelona
Spain	Fundacion Puigvert	Barcelona
Spain	CS Rincón de Loix	Benidorm	Alicante
Spain	CS Basurto	Bilbao	Vizcaya
Spain	CS Billabona	Billabona	Guipuzcoa
Spain	CS Cabra	Cabra	Cordoba
Spain	CAP Cornella	Cornella de Llobregat	Barcelona
Spain	CAP 17 setembre	El Prat de Llobregat	Barcelona
Spain	CAP Bartomeu Fabres Anglada	Gava	Barcelona
Spain	CAP Amadeu Torner	Hospitalet de Llobregat	Barcelona
Spain	CAP Florida Nord	Hospitalet de Llobregat	Barcelona
Spain	CS San Telmo	Jerez de la frontera	Cadiz
Spain	CAP Dr. Vicens Papaceit	La Roca del Valles	Barcelona
Spain	CS Legazpi	Legazpi	Guipuzcoa
Spain	CS Lucena	Lucena	Cordoba
Spain	CAP Les Bases-Manresa 3	Manresa	Barcelona
Spain	CAP El Maresme	Mataro	Barcelona
Spain	CAP La Riera	Mataro	Barcelona
Spain	CS Monzón Urbano	Monzon	Huesca
Spain	CAP Navas-Balsareny	Navas	Barcelona
Spain	CS Rute	Rute	Cordoba
Spain	CAP Remei	Vic	Barcelona
Spain	CS Arrabal	Zaragoza
Spain	CS Bombarda	Zaragoza
Spain	CS Sagasta Ruiseñores	Zaragoza
Spain	CS Torre Ramona	Zaragoza
Spain	CS Torrero La Paz	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Tedec-Meiji Farma, S.A.

Countries where clinical trial is conducted

Greece,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiological efficacy		5-9 days post-therapy	No
Secondary	Clinical efficacy		5-9 days post-therapy	No