Urinary Tract InfectionsPhase 3NCT00598403
Efficacy and Safety of Cefditoren Pivoxil Versus Ciprofloxacin in Acute Uncomplicated Cystitis
A Phase 3 study testing cefditoren pivoxil and Ciprofloxacin in people with Urinary Tract Infections, run by Tedec-Meiji Farma, S.A. at 30 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- cefditoren pivoxil and Ciprofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 611 participants
- Where
- 30 sitesin 2 countries
- Study dates
- Nov 2007to Jun 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
30 sites in 2 countries.
30 sites in 2 countries
Spain28 sites
CS Cabo Huertas
Alicante, 03540
CAP El Clot
Barcelona, 08018
Fundacion Puigvert
Barcelona, 08025
CS Rincón de Loix
Benidorm, Alicante, 03500
CS Basurto
Bilbao, Vizcaya, 48013
CS Billabona
Billabona, Guipuzcoa, 20150
CS Cabra
Cabra, Cordoba, 14940
CAP Cornella
Cornellà de Llobregat, Barcelona, 08940
CAP 17 setembre
el Prat de Llobregat, Barcelona, 08820
CAP Bartomeu Fabres Anglada
Gavà, Barcelona, 08850
CS San Telmo
Jerez de la Frontera, Cadiz, 11408
CAP Amadeu Torner
L'Hospitalet de Llobregat, Barcelona, 08902
CAP Florida Nord
L'Hospitalet de Llobregat, Barcelona, 08905
CAP Dr. Vicens Papaceit
La Roca del Vallès, Barcelona, 08430
CS Legazpi
Legazpi, Guipuzcoa, 20230
CS Lucena
Lucena, Cordoba, 14900
CAP Les Bases-Manresa 3
Manresa, Barcelona, 08243
CAP La Riera
Mataró, Barcelona, 08302
CAP El Maresme
Mataró, Barcelona, 08303
CS Monzón Urbano
Monzón, Huesca, 22400
CAP Navas-Balsareny
Navàs, Barcelona, 08670
CS Rute
Rute, Cordoba, 14960
CAP Remei
Vic, Barcelona, 08500
CS Sagasta Ruiseñores
Zaragoza, 50006
CS Torrero La Paz
Zaragoza, 50007
CS Torre Ramona
Zaragoza, 50013
CS Arrabal
Zaragoza, 50015
CS Bombarda
Zaragoza, 50017
Greece2 sites
General Hospital of Chest Disease of Athens
Athens
General Hospital of Thessaloniki
Thessaloniki
About this study
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
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.
Read the 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.
- Conditions
- Urinary Tract Infections
- Being tested
- cefditoren pivoxil, Ciprofloxacin
- Keywords
- Cystitis
- Medical subject headings
- Urinary Tract Infections, Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefditoren pivoxilDrug
Also called Meiact, Spectracef, Telo
400 mg, oral, single dose during 3 days
CiprofloxacinDrug
Also called Ciprofloxacino Mabo
250 mg, oral, twice a day for 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cefditoren pivoxil Receives: Drug: cefditoren pivoxil |
| 2 | Active comparator | Ciprofloxacin Receives: Drug: Ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological efficacy
Measured: 5-9 days post-therapy
Secondary outcomes (1)
Clinical efficacy
Measured: 5-9 days post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 611 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tedec-Meiji Farma, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jose L Ballve, Principal investigatorJosep R Toll, Principal investigatorRosa Viñas, Principal investigatorRosaura Figueras, Principal investigatorJoan Palou, Principal investigatorGabriel Martín, Principal investigatorRamon Pons, Principal investigatorManel Terns, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598403
- Sponsor's protocol ID
- TM-ME1207/311
- Other IDs
- 2007-001486-15
- Status last verified
- Jun 2010
- First submitted
- 9 Jan 2008
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00598403
- Acronym / sponsor ID
- TM-ME1207/311
- Conditions
- Urinary Tract Infections
- Keywords
- Cystitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 611 participants (actual)
- Lead sponsor
- Tedec-Meiji Farma, S.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 21 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: cefditoren pivoxilCefditoren pivoxil |
| 2 | Active comparator | Drug: CiprofloxacinCiprofloxacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cefditoren pivoxilAlso: Meiact, Spectracef, Telo400 mg, oral, single dose during 3 days | Drug | 1 |
| CiprofloxacinAlso: Ciprofloxacino Mabo250 mg, oral, twice a day for 3 days | Drug | 2 |
Primary outcome
Microbiological efficacy
Time frame: 5-9 days post-therapy
1 secondary outcome
Clinical efficacy
Time frame: 5-9 days post-therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose L Ballve principal investigator
Josep R Toll principal investigator
Rosa Viñas principal investigator
30 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cefditoren pivoxil and Ciprofloxacin in people with Urinary Tract Infections, run by Tedec-Meiji Farma, S.A. at 30 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Spain, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological efficacy (time frame: 5-9 days post-therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2010; AzTrials last refreshed its copy on 8 Nov 2026.