Urinary Tract InfectionPhase 4TEANCT01543347
Temocillin Use in Complicated Urinary Tract Infections Due to Extended Spectrum Beta-Lactamases (ESBL)/AmpC Enterobacteriaceae
A Phase 4 study testing Temocillin in people with Urinary Tract Infection, run by Belpharma s.a. at 1 site in United Kingdom.
Trial summary
This study is aimed at demonstrating the efficacy of temocillin in the treatment of complicated Urinary Tract Infection (UTI) due to confirmed Extended Spectrum Beta-Lactamases (ESBL) producing or AmpC hyperproducing Enterobacteriaceae in the United Kingdom. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Temocillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2012to Nov 2012
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients presenting a complicated urinary tract infection due to a confirmed Extended Spectrum Beta-Lactamases (ESBL) producing or AmpC hyperproducing Enterobacteriaceae susceptible to temocillin requiring parenteral antimicrobial therapy.
- community or hospital acquired infecting bacteria.
- signed informed consent
Who cannot join
- patients infected with a strain resistant to temocillin
- patients having received an active antimicrobial therapy during the 48h before the beginning of temocillin treatment except temocillin
- patients presenting another site of infection than urinary (except onset of bacteremia from urinary tract origin) due to Gram negative bacteria
- patients needing concomitant antimicrobial therapy with the exception of benzylpenicillin
- uncomplicated cystitis
- complete obstruction of the urinary tract
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- prostatitis
- peri-nephretic or intrarenal abscesses
- renal transplant
- children (up to 18 years old)
- pregnancy or lactation
- chronically dialyzed patients
- immunocompromising therapy or illness
- known allergy to penicillin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temocillin Use in Complicated Urinary Tract Infections Due to Extended Spectrum Beta-Lactamases (ESBL) Producing and AmpC Hyperproducing Enterobacteriaceae in United Kingdom
This study is aimed at demonstrating the efficacy of temocillin in the treatment of complicated Urinary Tract Infection (UTI) due to confirmed Extended Spectrum Beta-Lactamases (ESBL) producing or AmpC hyperproducing Enterobacteriaceae in the United Kingdom.
Read the detailed description
The spectrum of activity together with the route of excretion of temocillin makes it a good candidate for the treatment of urinary tract infections. Several studies have shown very good clinical and microbiological activity in uncomplicated and complicated cystitis and pyelonephritis in adults and in pyelonephritis in children older than 2 months. However there is no specific study performed on Urinary Tract Infections due to broad spectrum ß-lactamases producing strains.
In this context, this study is aimed at demonstrating the efficacy of temocillin in the treatment of complicated Urinary Tract Infection due to confirmed Extended Spectrum Beta-Lactamases (ESBL) producing or AmpC hyperproducing Enterobacteriaceae in the United Kingdom. The investigators will also evaluate the tolerance of the drug by monitoring the adverse event and the incidence of eventual Clostridium difficile associated infection.
- Conditions
- Urinary Tract Infection
- Being tested
- Temocillin
- Keywords
- UTI, ESBL, AmpC Enterobacteriaceae
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemocillinDrug
Also called Negaban
Antibiotic treatment
| Study group | Role | What they receive |
|---|---|---|
| Temocillin | Experimental | Treatment group Receives: Drug: Temocillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological cure
Eradication : < 10,000 Colony forming Unit/mL (CFU/mL) of the baseline pathogen
- Persistence : = 10,000 CFU/mL of the baseline pathogen
- Persistence with acquisition of resistance
- Superinfection : = 100,000 CFU/mL of another uropathogen during therapy
- New infection : = 100,000 CFU/mL of another uropathogen after therapy
- Relapse : eradication at end of treatment but = 10,000 CFU/mL of the baseline pathogen at follow up
- Relapse with acquisition of resistance
Measured: End of treatment (minimum 5 days)
Secondary outcomes (6)
Clinical cure
Clinical status of the patient will be classified as
- cured (resolution of all clinical symptoms)
- improved
- failure (persistence of baseline clinical symptoms or emergence of new symptoms)
Measured: End of treatment (minimum 5 days)
Development of resistance during treatment
Acquisition of resistance to temocillin during treatment on a microbiological point of view
Measured: End of treatment (minimum 5 days)
Infection relapses monitored over 4-6 weeks
- Relapse : eradication at end of treatment but = 10,000 CFU/mL of the baseline pathogen at follow up
- Relapse with acquisition of resistance
Measured: End of follow-up (up to 6 weeks)
Monitoring of AE
Record of any untoward medical occurrence in a clinical trial patient administered temocillin and which does not necessarily have to have a causal relationship with the treatment.
Measured: From day 0 to up to 6 weeks
ESBL & AmpC fecal carriage (optional)
All isolates of included patients will be kept frozen at -80°C and sent to the central laboratory for ESBL/AmpC confirmation and typing through molecular techniques. Pulse field gel electrophoresis will be performed on isolates from the same species for determination of clonality.
Measured: Start and end of treatment (minimum 5 days)
Incidence of C. difficile infection
Clostridium difficile infection (CDI) is defined as recommended by the HPA Steering Group on Healthcare Associated Infection 35 : one episode of diarrhoea, defined either as stool loose enough to take the shape of a container used to sample it, or as Bristol Stool Chart types 5-7, which is not attributable to any other cause including medicines which occurs at the same time as a positive toxin assay (with or without a positive C. difficile culture) and/or endoscopic evidence of pseudomembranous colitis.
Measured: From day 0 to up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: No patient has been included in 9 months because of strict incl/excl criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belpharma s.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter M Hawkey, Professor, Principal investigator, Birmingham Public Health Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543347
- Sponsor's protocol ID
- TMO-07001
- Other IDs
- 2008-005912-41, 2008
- Acronym
- TEA
- Status last verified
- Jan 2013
- First submitted
- 22 Feb 2012
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temocillin Use in Complicated Urinary Tract Infections Due to Extended Spectrum Beta-Lactamases (ESBL) Producing and AmpC Hyperproducing Enterobacteriaceae in United Kingdom
- ClinicalTrials.gov ID
- NCT01543347
- Acronym / sponsor ID
- TEA / TMO-07001
- Conditions
- Urinary Tract Infection
- Keywords
- UTI, ESBL, AmpC Enterobacteriaceae
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patient has been included in 9 months because of strict incl/excl criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Belpharma s.a.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 5 Mar 2012 (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.
This study is aimed at demonstrating the efficacy of temocillin in the treatment of complicated Urinary Tract Infection (UTI) due to confirmed Extended Spectrum Beta-Lactamases (ESBL) producing or AmpC hyperproducing Enterobacteriaceae in the United Kingdom.
Detailed description
The spectrum of activity together with the route of excretion of temocillin makes it a good candidate for the treatment of urinary tract infections. Several studies have shown very good clinical and microbiological activity in uncomplicated and complicated cystitis and pyelonephritis in adults and in pyelonephritis in children older than 2 months. However there is no specific study performed on Urinary Tract Infections due to broad spectrum ß-lactamases producing strains.
In this context, this study is aimed at demonstrating the efficacy of temocillin in the treatment of complicated Urinary Tract Infection due to confirmed Extended Spectrum Beta-Lactamases (ESBL) producing or AmpC hyperproducing Enterobacteriaceae in the United Kingdom. The investigators will also evaluate the tolerance of the drug by monitoring the adverse event and the incidence of eventual Clostridium difficile associated infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temocillin | Experimental | Drug: TemocillinTreatment group |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients presenting a complicated urinary tract infection due to a confirmed Extended Spectrum Beta-Lactamases (ESBL) producing or AmpC hyperproducing Enterobacteriaceae susceptible to temocillin requiring parenteral antimicrobial therapy.
- community or hospital acquired infecting bacteria.
- signed informed consent
Key exclusion criteria (14 listed)
- patients infected with a strain resistant to temocillin
- patients having received an active antimicrobial therapy during the 48h before the beginning of temocillin treatment except temocillin
- patients presenting another site of infection than urinary (except onset of bacteremia from urinary tract origin) due to Gram negative bacteria
- patients needing concomitant antimicrobial therapy with the exception of benzylpenicillin
- uncomplicated cystitis
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 |
|---|---|---|
| TemocillinAlso: NegabanAntibiotic treatment | Drug | Temocillin |
Primary outcome
Microbiological cure
Time frame: End of treatment (minimum 5 days)
Eradication : < 10,000 Colony forming Unit/mL (CFU/mL) of the baseline pathogen * Persistence : = 10,000 CFU/mL of the baseline pathogen * Persistence with acquisition of resistance * Superinfection : = 100,000 CFU/mL of another uropathogen during therapy * New infection : = 100,000 CFU/mL of another uropathogen after therapy * Relapse : eradication at end of treatment but = 10,000 CFU/mL of the baseline pathogen at follow up * Relapse with acquisition of resistance
6 secondary outcomes
Clinical cure
Time frame: End of treatment (minimum 5 days)
Development of resistance during treatment
Time frame: End of treatment (minimum 5 days)
Infection relapses monitored over 4-6 weeks
Time frame: End of follow-up (up to 6 weeks)
Monitoring of AE
Time frame: From day 0 to up to 6 weeks
ESBL & AmpC fecal carriage (optional)
Time frame: Start and end of treatment (minimum 5 days)
Incidence of C. difficile infection
Time frame: From day 0 to up to 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
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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.
Peter M Hawkey, Professor principal investigator
Birmingham Public Health Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Temocillin in people with Urinary Tract Infection, run by Belpharma s.a. at 1 site in United Kingdom.
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 3 inclusion and 14 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: withdrawn, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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 cure (time frame: End of treatment (minimum 5 days)). 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 Jan 2013.