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Urinary Tract InfectionsPhase 3TEMO-CARBNCT03543436

Temocillin Versus a Carbapenem as Initial Intravenous Treatment for ESBL Related Urinary Tract Infections

A Phase 3 study testing Temocillin and meropenem or imipenem in people with Urinary Tract Infections, run by Assistance Publique - Hôpitaux de Paris at 16 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

TEMO-CARB is a phase 3, randomized, controlled, multicentre, open-label pragmatic clinical trial to test the non-inferiority of temocillin versus carbapenem as initial intravenous treatment of Urinary Tract Infection (UTI) due to extended-spectrum beta-lactamase (ESBL) producing enterobacteriaceae. 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 and meropenem or imipenem
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
16 sitesFrance
Study dates
4 Jan 2019to 14 Dec 2020
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult (≥ 18 years)
  • Hospitalized patient with clinically significant monomicrobial UTI
  • Complicated UTI due to ESBL producing enterobacteriaceae (pyelonephritis, prostatitis or renal abscess) requiring parenteral antimicrobial therapy
  • Susceptibility to temocillin and carbapenem as evidenced by testing results
  • For woman able to procreate: negative pregnancy test and use of an effective method of contraception (abstinence, oral contraceptives, intra-uterine device, diaphragm with spermicide and condom). All forms of hormonal contraception are acceptable
  • Signed informed consent by patient himself (able or under curatorship) or his legal representative (patient unable to give his consent or under tutorship)
  • Patient affiliated to the social security system

Who cannot join

  • Patient infected with a bacteria which is not an ESBL-producing enterobacteriaceae.
  • Polymicrobial infection.
  • Hypersensitivity and/or previous intolerance to carbapenem or temocillin, or penicillins or any other beta-lactam.
  • Patient with a contraindication to any of the drugs to be used in research
  • Patient presenting another site of infection than urinary (except onset of bacteraemia from urinary tract origin due to Gram negative bacteria).
  • Woman who is pregnant, breastfeeding, or expecting to conceive at any time during the study (pregnancy test will be conducted for woman without menopause).
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  • Palliative care of life expectancy < 90 days.
  • Ongoing empirical treatment of the urinary tract infections with carbapenem or temocillin > 24 hours before randomization
  • Delay in randomization > 48 hours after identification of ESBL producing enterobacteriaceae in urinary and/or blood culture.
  • Participation in other clinical trial for the infection.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites

  • CHRU La Cavale Blanche

    Brest, 29000

  • CHU de Martinique

    Fort-de-france, Martinique

  • CHU de Grenoble Hospital

    Grenoble

  • Melun Hospital - CHU Sud

    Melun, 77

  • APHP - Cochin Hospital

    Paris, 75014

  • APHP - Necker-Enfants maladies Hospital

    Paris, 75015

  • Bichat hospital

    Paris, 75018

  • Groupe Hospitalier Diaconesses Croix Saint Simon

    Paris, 75020

  • Tenon Hospital

    Paris, 75020

  • APHP - Beaujon Hospital

    Paris

  • APHP - Georges Pompidou European Hospital

    Paris

  • APHP - Saint-Antoine Hospital

    Paris

  • Saint-Joseph Hospital

    Paris

  • CHU de Pau

    Pau

  • CHU de Poitiers

    Poitiers

  • CHU Pontchaillou

    Rennes, 35000

Other trials in France

About this study

Official title: Temocillin Versus a Carbapenem as Initial Intravenous Treatment for Extended-spectrum Beta-lactamase Related Urinary Tract Infections, a Non-inferiority Study

TEMO-CARB is a phase 3, randomized, controlled, multicentre, open-label pragmatic clinical trial to test the non-inferiority of temocillin versus carbapenem as initial intravenous treatment of Urinary Tract Infection (UTI) due to extended-spectrum beta-lactamase (ESBL) producing enterobacteriaceae.

Read the detailed description

Urinary tract infections are among the most common bacterial infections that are treated in the community by an empirical antibiotic treatment regimen. Enterobacteriaceae are the most common bacteria involved in urinary tract infection. Since 2006, extended-spectrum beta-lactamase (ESBL) producing enterobacteriaceae have spread in France, as elsewhere. Finding therapeutic alternatives to carbapenems in infections caused by ESBL producing enterobacteriaceae is imperative. Although temocillin, 6-α-methoxy derivative of ticarcillin has been suggested as a potential alternative to carbapenem therapy for ESBL related infections, it was not investigated in accordance with current standard. The hypothesis to test in this study is that temocillin is not inferior to a carbapenem as initial intravenous treatment of urinary tract infections caused by ESBL producing enterobacteriaceae.

Being tested
Temocillin, meropenem or imipenem
Keywords
Non-inferiority study, Temocillin, Carbapenem, ESBL infection, Urinary tract infection
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

    Intravenous temocillin disodium 2g intravenously/8h Or Renally Adjusted Equivalent (ORAE) in 30-40 min infusion or continuous intravenous (6g/24h) .

  • meropenem or imipenemDrug

    Also called Carbapenems

    Intravenous carbapenem (meropenem 1g intravenously/8h Or Renally Adjusted Equivalent (ORAE) or imipenem 1g intravenously/8h ORAE)

Study groups in NCT03543436
Study groupRoleWhat they receive
Intravenous temocillinExperimentalIntravenous temocillin 2g/intravenously/8h or renally adjusted equivalent (ORAE) in 30-40 min infusion or continuous intravenous (6g/24h)
Receives: Drug: Temocillin
Intravenous meropenem or imipenemActive comparatorIntravenous meropenem or imipenem 1g/Intravenously /8h ORAE in 15-30 min infusion. Then switch to oral therapy
Receives: Drug: meropenem or imipenem

What is being measured

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

  1. Clinical and microbiological cure

    The primary endpoint, was defined as achieving both clinical cure and microbiological eradication of all baseline pathogens 5-7 days after completion of treatment.

    Clinical cure is defined as complete resolution, substantial improvement or return to pre-infections signs and symptoms of complicated lower urinary tract infections or pyelonephritis without the need for additional antibiotic therapy Microbiological efficacy will be assessed by quantitative urine culture and defined as follows < 10^3 Colony Forming Unit (CFU)/mL of the baseline pathogens

    Measured: 5-7 days after end of treatment

Secondary outcomes (8)

  1. Early microbiological eradication

    Microbiological eradication will be assessed by quantitative urine culture and defined as follows < 10^3 colony forming unit Colony Forming Unit (CFU)/mL of the baseline pathogens

    Measured: 3-4 days after randomization

  2. Frequency of oral antibiotic switch in both arms (temocillin vs. carbapenem)

    Measured: 60 days after randomization

  3. Length of hospital stay

    Time from randomization to hospital discharge

    Measured: 60 days after randomization

  4. Persistent cure rate

    Clinical cure is defined as complete resolution, substantial improvement or return to pre-infections signs and symptoms of complicated lower urinary tract infections or pyelonephritis without the need for additional antibiotic therapy

    Measured: 60 days after randomization

  5. Clinical recurrences

    Relapse: new symptoms of urinary tract infection in a patient previously considered as clinically or microbiologically cured in the visit 5-7 days after treatment completion plus positive urine ± blood culture grows the same microorganism isolated that in the initial culture.

    Re-infection: same definition but with different strain in urinary culture

    Measured: 60 days after randomization

  6. Mortality

    Death for any reason or for infectious events

    Measured: 60 days after randomization

  7. Pharmacokinetic of temocillin according to kidney function

    Description of the temocillin plasma concentration and its variability among patients

    Measured: 3 days after treatment initiation

  8. Microbiota impact study

    Study treatment impact in the gut colonization with multidrug Gram negative bacilli) and temocillin resistant Gram negative bacilli

    Measured: Time Frame : 5-7 days after treatment completion

Timeline

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

  1. First posted1 Jun 2018
  2. Study start4 Jan 2019
  3. Primary completion29 Oct 2020
  4. Study completion14 Dec 2020

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03543436
Sponsor's protocol ID
P 160910J
Other IDs
2017-001257-14, 2017
Acronym
TEMO-CARB
Status last verified
Oct 2025
First submitted
18 May 2018
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Temocillin and meropenem or imipenem in people with Urinary Tract Infections, run by Assistance Publique - Hôpitaux de Paris at 16 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 7 inclusion and 10 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 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 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?

Clinical and microbiological cure (time frame: 5-7 days after end of 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 NCT03543436.

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 20 Nov 2025.

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