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

June 28, 2010 updated by: Tedec-Meiji Farma, S.A.

Multicentre, Prospective, Comparative, Randomized, Double-blind, Double-dummy Study to Assess the Efficacy and Safety of Cefditoren Pivoxil vs. Ciprofloxacin in Uncomplicated Acute Cystitis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
611

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • General Hospital of Chest Disease of Athens
      • Thessaloniki, Greece
        • General Hospital of Thessaloniki
  • Spain
      • Alicante, Spain, 03540
        • CS Cabo Huertas
      • Barcelona, Spain, 08025
        • Fundación Puigvert
      • Barcelona, Spain, 08018
        • CAP El Clot
      • Zaragoza, Spain, 50006
        • CS Sagasta Ruiseñores
      • Zaragoza, Spain, 50007
        • CS Torrero La Paz
      • Zaragoza, Spain, 50013
        • CS Torre Ramona
      • Zaragoza, Spain, 50015
        • CS Arrabal
      • Zaragoza, Spain, 50017
        • CS Bombarda
    • Alicante
      • Benidorm, Alicante, Spain, 03500
        • CS Rincón de Loix
    • Barcelona
      • Cornella de Llobregat, Barcelona, Spain, 08940
        • CAP Cornella
      • El Prat de Llobregat, Barcelona, Spain, 08820
        • CAP 17 setembre
      • Gava, Barcelona, Spain, 08850
        • CAP Bartomeu Fabres Anglada
      • Hospitalet de Llobregat, Barcelona, Spain, 08902
        • CAP Amadeu Torner
      • Hospitalet de Llobregat, Barcelona, Spain, 08905
        • CAP Florida Nord
      • La Roca del Valles, Barcelona, Spain, 08430
        • CAP Dr. Vicens Papaceit
      • Manresa, Barcelona, Spain, 08243
        • CAP Les Bases-Manresa 3
      • Mataro, Barcelona, Spain, 08302
        • CAP La Riera
      • Mataro, Barcelona, Spain, 08303
        • CAP El Maresme
      • Navas, Barcelona, Spain, 08670
        • CAP Navas-Balsareny
      • Vic, Barcelona, Spain, 08500
        • CAP Remei
    • Cadiz
      • Jerez de la frontera, Cadiz, Spain, 11408
        • CS San Telmo
    • Cordoba
      • Cabra, Cordoba, Spain, 14940
        • CS Cabra
      • Lucena, Cordoba, Spain, 14900
        • CS Lucena
      • Rute, Cordoba, Spain, 14960
        • CS Rute
    • Guipuzcoa
      • Billabona, Guipuzcoa, Spain, 20150
        • CS Billabona
      • Legazpi, Guipuzcoa, Spain, 20230
        • CS Legazpi
    • Huesca
      • Monzon, Huesca, Spain, 22400
        • CS Monzón Urbano
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • CS Basurto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Cefditoren pivoxil
Drug: cefditoren pivoxil
400 mg, oral, single dose during 3 days
Other Names:
  • Meiact, Spectracef, Telo
Active Comparator: 2
Ciprofloxacin
Drug: Ciprofloxacin
250 mg, oral, twice a day for 3 days
Other Names:
  • Ciprofloxacino Mabo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Microbiological efficacy
Time Frame: 5-9 days post-therapy
5-9 days post-therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Clinical efficacy
Time Frame: 5-9 days post-therapy
5-9 days post-therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tedec-Meiji Farma, S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TM-ME1207/311
  • 2007-001486-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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