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Urinary Tract InfectionsPhase 4TEMO-ESBLNCT02681263

Efficacy of Temocillin in Urinary Tract Infection Due to ESBL Producing and AmpC Hyperproducing Enterobacteriaceae

A Phase 4 study testing Temocillin in people with Urinary Tract Infections, run by University Hospital, Grenoble at 19 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The present study aims at demonstrating the efficacy of temocillin in the treatment of UTI requiring parenteral therapy due to a confirmed ESBL producing or AmpC hyperproducing Enterobacteriaceae, resistant to quinolones and Bactrim® in France. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Tract Infections
What is being tested?
Temocillin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
19 sitesFrance
Study dates
Apr 2016to Sep 2018
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age of at least 18 year old
  • Patient benefits from social security
  • Signed informed consent
  • A urinary tract infection due to a confirmed ESBL producing strain (detected by the use of a rapid diagnostic test applied on the urine) requiring parenteral antimicrobial therapy
  • Hospitalized patient
  • For women able to procreate: Use of an acceptable method of birth control throughout the study. Acceptable methods of birth control are: oral contraceptives, intrauterine device (IUD), diaphragm with spermicide and condom. (All forms of hormonal contraception are acceptable

Who cannot join

  • Patient infected with a bacteria which is not an ESBL-producing or AmpC hyperproducing Enterobacteriaceae
  • Patients infected with a strain sensible to both fluoroquinolones and trimethoprim/sulfamethoxazole
  • Patients infected with a strain resistant to temocillin
  • Hospital-acquired urinary tract infection (defined as a urinary infection that occurred at least 48h post admission in the hospital)
  • Patients has received any dose of active antimicrobial therapy (an antibiotic to which the infecting bacterium is susceptible) in the last 48h (prior to enrolment) except ≤ 2 dose of gentamicin.
  • Patients presenting another site of infection than urinary (except onset of bacteraemia from urinary tract origin) due to Gram negative bacteria.
Show all 18Show fewer
  • Patients needing concomitant antimicrobial therapy.
  • Septic shock
  • Children (up to 18 years old)
  • Women who is pregnant, breastfeeding, or expecting to conceive at any time during the study (pregnancy test will be conducted for woman without menopause)
  • Patients with any kind of urinary/bladder catheter (JJ ureteral probe, …)
  • Hypersensitivity to the active substance, to penicillins or to any other type of beta-lactam agent
  • Chronically dialyzed patients
  • Patients having a creatinine clearance < 30 mL/min
  • Complete obstruction of the urinary tract
  • Perinephretic or intrarenal abscesses
  • Tutorship or curatorship patient
  • Patient unable to give his consent

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

France19 sites

  • CH Ajaccio

    Ajaccio

  • CH Annecy Genevois

    Annecy

  • APHP - Avicenne Hospital

    Bobigny

  • APHP - Beaujon Hospital

    Clichy

  • CHU de Martinique

    Fort de France

  • CHU de Grenoble

    Grenoble

  • APHP - Bicêtre Hospital

    Le Kremlin-Bicêtre

  • CHU de Lille

    Lille

  • CHU de Nantes

    Nantes

  • CHU de Nice

    Nice

  • APHP - Bichat Hospital

    Paris

  • APHP - Cochin Hospital

    Paris

  • APHP - St Louis

    Paris

  • CH de Perpignan

    Perpignan

  • CHU de Pointe à Pitre

    Pointe à Pitre

  • CHU de Poitiers

    Poitiers

  • CHU de Rouen

    Rouen

  • CHU de Saint Etienne

    Saint-Etienne

  • CHU de Tours

    Tours

Other trials in France

About this study

The present study aims at demonstrating the efficacy of temocillin in the treatment of UTI requiring parenteral therapy due to a confirmed ESBL producing or AmpC hyperproducing Enterobacteriaceae, resistant to quinolones and Bactrim® in France. In addition, this study will describe and support the use of high dose (6g/day) of temocillin which could be of interest for the treatment urinary tract infection due to multi-resistant bacteria having high MIC (up to 32 mg/L). The investigators will also evaluate the tolerance of the drug by monitoring the adverse event and the incidence of eventual Clostridium difficile associated infection.

Being tested
Temocillin
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

    Treatment duration with a minimum of 5 days administration of the study drug: Temocillin (Negaban®) 6g/day (2g/tid) and as monotherapy.

Study groups in NCT02681263
Study groupRoleWhat they receive
TemocillinExperimentalTreatment duration with a minimum of 5 days administration of the study drug: Temocillin (Negaban®) 6g/day (2g/tid) and as monotherapy. Total antibiotic treatment between 10 and 14 days according to local guidelines (up to 21 days in immunosuppressed patients).
Receives: Drug: Temocillin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Microbiological efficacy at Test of Cure in patients microbiologically evaluable

    The microbiological efficacy will be assessed by quantitative urine culture and defined as follows:

    • Eradication : < 10^3 CFU/mL of the baseline pathogen
    • Persistence : ≥ 10^3 CFU/ml of the baseline pathogen
    • Superinfection : ≥ 10^5 CFU/ml of another uropathogen during therapy
    • New infection : ≥ 10^5 CFU/ml of another uropathogen after therapy
    • Relapse : eradication at TOC but ≥ 10^3 CFU/mL of the baseline pathogen at FU Overall microbiological response will be determined as "unfavorable" if persistence or superinfection or new infection or relapse.

    Measured: 7 days post end of Temocillin Treatment

Secondary outcomes (3)

  1. Clinical efficacy in clinical evaluable group

    Each patient's response will be categorized as cure (resolution of all clinical symptoms), improvement (normalization of body temperature but persistence of either urinary syndrome or flank pain) or failure (persistence of baseline clinical symptoms or emergence of new symptoms related to UTI).

    Measured: 3 weeks for end of Temocillin Treatment

  2. Microbiological efficacy

    The microbiological efficacy will be assessed by quantitative urine culture and defined as follows:

    • Eradication : < 10^3 CFU/mL of the baseline pathogen
    • Persistence : ≥ 10^3 CFU/ml of the baseline pathogen
    • Superinfection : ≥ 10^5 CFU/ml of another uropathogen during therapy
    • New infection : ≥ 10^5 CFU/ml of another uropathogen after therapy
    • Relapse : eradication at TOC but ≥ 10^3 CFU/mL of the baseline pathogen at FU

    Measured: 3 weeks for end of Temocillin Treatment

  3. Development of resistance to temocillin during treatment

    The acquisition of resistance will be monitored in the central laboratory and is defined as an increase in MIC of at least 4 dilutions.

    Measured: 3 weeks for end of Temocillin Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionApr 2018
  4. Study completionSep 2018 (estimated)

Resources

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
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02681263
Sponsor's protocol ID
38RC15.213
Other IDs
2015-004178-14, 2015
Acronym
TEMO-ESBL
Status last verified
Jun 2018
First submitted
27 Nov 2015
Last updated
6 Jun 2018
Results posted
No
Data monitoring committee
No

Publications

  • Laterre PF, Wittebole X, Van de Velde S, Muller AE, Mouton JW, Carryn S, Tulkens PM, Dugernier T. Temocillin (6 g daily) in critically ill patients: continuous infusion versus three times daily administration. J Antimicrob Chemother. 2015 Mar;70(3):891-8. doi: 10.1093/jac/dku465. Epub 2014 Nov 27.

    PubMed 25433006

  • Balakrishnan I, Awad-El-Kariem FM, Aali A, Kumari P, Mulla R, Tan B, Brudney D, Ladenheim D, Ghazy A, Khan I, Virgincar N, Iyer S, Carryn S, Van de Velde S. Temocillin use in England: clinical and microbiological efficacies in infections caused by extended-spectrum and/or derepressed AmpC beta-lactamase-producing Enterobacteriaceae. J Antimicrob Chemother. 2011 Nov;66(11):2628-31. doi: 10.1093/jac/dkr317. Epub 2011 Aug 2.

    PubMed 21810837

  • Fournier D, Chirouze C, Leroy J, Cholley P, Talon D, Plesiat P, Bertrand X. Alternatives to carbapenems in ESBL-producing Escherichia coli infections. Med Mal Infect. 2013 Feb;43(2):62-6. doi: 10.1016/j.medmal.2013.01.006. Epub 2013 Feb 19.

    PubMed 23433608

  • Schulze B, Heilmann HD. Treatment of severe infections with temocillin. Clinical and bacteriological evaluation. Drugs. 1985;29 Suppl 5:207-9. doi: 10.2165/00003495-198500295-00046.

    PubMed 4029026

  • De Jongh R, Hens R, Basma V, Mouton JW, Tulkens PM, Carryn S. Continuous versus intermittent infusion of temocillin, a directed spectrum penicillin for intensive care patients with nosocomial pneumonia: stability, compatibility, population pharmacokinetic studies and breakpoint selection. J Antimicrob Chemother. 2008 Feb;61(2):382-8. doi: 10.1093/jac/dkm467. Epub 2007 Dec 10.

    PubMed 18070831

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Temocillin in people with Urinary Tract Infections, run by University Hospital, Grenoble at 19 sites in France.

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 6 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France. 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?

Results are not available in the source record.

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 at Test of Cure in patients microbiologically evaluable (time frame: 7 days post end of Temocillin Treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02681263, which also lists 5 linked publications.

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 6 Jun 2018.

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