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

NCT00598403 | Completed Phase 3

• 2 other identifiers: TM-ME1207/3112007-001486-15
• Study Type: interventional
• Target: 611
• Locations: 2 countries
• Sites: 30

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.

Conditions

Urinary Tract Infections

Keywords

Cystitis

Outcome Measures

Primary Outcomes (1)

• Microbiological efficacy

  5-9 days post-therapy

Secondary Outcomes (1)

• Clinical efficacy

  5-9 days post-therapy

Study Arms (2)

1

EXPERIMENTAL

Cefditoren pivoxil

Drug: cefditoren pivoxil

2

ACTIVE COMPARATOR

Ciprofloxacin

Drug: Ciprofloxacin

Interventions

cefditoren pivoxil DRUG

400 mg, oral, single dose during 3 days

Also known as: Meiact, Spectracef, Telo

1

Ciprofloxacin DRUG

250 mg, oral, twice a day for 3 days

Also known as: Ciprofloxacino Mabo

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• In vitro susceptibility testing of the isolated uropathogen to the drugs under study
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Tedec-Meiji Farma, S.A.: lead

Study Sites (30)

General Hospital of Chest Disease of Athens

Athens, Greece

Location

General Hospital of Thessaloniki

Thessaloniki, Greece

Location

CS Rincón de Loix

Benidorm, Alicante, 03500, Spain

Location

CAP Cornella

Cornellà de Llobregat, Barcelona, 08940, Spain

Location

CAP 17 setembre

el Prat de Llobregat, Barcelona, 08820, Spain

Location

CAP Bartomeu Fabres Anglada

Gavà, Barcelona, 08850, Spain

Location

CAP Amadeu Torner

L'Hospitalet de Llobregat, Barcelona, 08902, Spain

Location

CAP Florida Nord

L'Hospitalet de Llobregat, Barcelona, 08905, Spain

Location

CAP Dr. Vicens Papaceit

La Roca del Vallès, Barcelona, 08430, Spain

Location

CAP Les Bases-Manresa 3

Manresa, Barcelona, 08243, Spain

Location

CAP La Riera

Mataró, Barcelona, 08302, Spain

Location

CAP El Maresme

Mataró, Barcelona, 08303, Spain

Location

CAP Navas-Balsareny

Navàs, Barcelona, 08670, Spain

Location

CAP Remei

Vic, Barcelona, 08500, Spain

Location

CS San Telmo

Jerez de la Frontera, Cadiz, 11408, Spain

Location

CS Cabra

Cabra, Cordoba, 14940, Spain

Location

CS Lucena

Lucena, Cordoba, 14900, Spain

Location

CS Rute

Rute, Cordoba, 14960, Spain

Location

CS Billabona

Billabona, Guipuzcoa, 20150, Spain

Location

CS Legazpi

Legazpi, Guipuzcoa, 20230, Spain

Location

CS Monzón Urbano

Monzón, Huesca, 22400, Spain

Location

CS Basurto

Bilbao, Vizcaya, 48013, Spain

Location

CS Cabo Huertas

Alicante, 03540, Spain

Location

CAP El Clot

Barcelona, 08018, Spain

Location

Fundacion Puigvert

Barcelona, 08025, Spain

Location

CS Sagasta Ruiseñores

Zaragoza, 50006, Spain

Location

CS Torrero La Paz

Zaragoza, 50007, Spain

Location

CS Torre Ramona

Zaragoza, 50013, Spain

Location

CS Arrabal

Zaragoza, 50015, Spain

Location

CS Bombarda

Zaragoza, 50017, Spain

Location

MeSH Terms

Conditions

Urinary Tract Infections; Cystitis

Interventions

cefditoren pivoxil; Ciprofloxacin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jose L Ballve

  PRINCIPAL INVESTIGATOR

• Josep R Toll

  PRINCIPAL INVESTIGATOR

• Rosa Viñas

  PRINCIPAL INVESTIGATOR

• Rosaura Figueras

  PRINCIPAL INVESTIGATOR

• Joan Palou

  PRINCIPAL INVESTIGATOR

• Gabriel Martín

  PRINCIPAL INVESTIGATOR

• Ramon Pons

  PRINCIPAL INVESTIGATOR

• Manel Terns

  PRINCIPAL INVESTIGATOR

• Josep L Fernandez

  PRINCIPAL INVESTIGATOR

• Pere Toran

  PRINCIPAL INVESTIGATOR

• Pilar Montero

  PRINCIPAL INVESTIGATOR

• Bingen Uriondo

  PRINCIPAL INVESTIGATOR

• Pablo Daza

  PRINCIPAL INVESTIGATOR

• Jesus Zorita

  PRINCIPAL INVESTIGATOR

• Ander Larrazabal

  PRINCIPAL INVESTIGATOR

• Natividad Gonzalez

  PRINCIPAL INVESTIGATOR

• Jose F Magdalena

  PRINCIPAL INVESTIGATOR

• Fernando Martin

  PRINCIPAL INVESTIGATOR

• Jose Porta

  PRINCIPAL INVESTIGATOR

• Mª Rosa Magallon

  PRINCIPAL INVESTIGATOR

• Mª Sol Reixa

  PRINCIPAL INVESTIGATOR

• Jesus Torrecilla

  PRINCIPAL INVESTIGATOR

• Isabel Blasco

  PRINCIPAL INVESTIGATOR

• Antonio Hidalgo

  PRINCIPAL INVESTIGATOR

• Alicia Alvarez

  PRINCIPAL INVESTIGATOR

• Gabriel Romera

  PRINCIPAL INVESTIGATOR

• Estrella Castro

  PRINCIPAL INVESTIGATOR

• Manuel M Ortega

  PRINCIPAL INVESTIGATOR

• Salvador Pertusa

  PRINCIPAL INVESTIGATOR

• Manuel Ramirez

  PRINCIPAL INVESTIGATOR

• Aggelos Pefanis

  PRINCIPAL INVESTIGATOR

• Chatzimouratidis

  PRINCIPAL INVESTIGATOR

• Jose V Vaquer

  PRINCIPAL INVESTIGATOR

• Nicolas Salvador

  PRINCIPAL INVESTIGATOR

• Jose L Pardo

  PRINCIPAL INVESTIGATOR

• Joaquin Aracil

  PRINCIPAL INVESTIGATOR

• Mª Jesus Barreda

  PRINCIPAL INVESTIGATOR

• Artemio Alvarez

  PRINCIPAL INVESTIGATOR

• Vicente Lopez

  PRINCIPAL INVESTIGATOR

• Panagiotis Gargalianos

  PRINCIPAL INVESTIGATOR

• Dolores M Maestre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 21, 2008
• Study Start: November 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2010
• Last Updated: June 29, 2010

Record last verified: 2010-06

Locations

ES (28); GR (2)