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Completed

NCT Number: NCT03543436

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

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.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Martinique, Fort-de-france, Martinique, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).
  • 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.

Treatment and study plan

Temocillin

Drug

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

meropenem or imipenem

Drug

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

Other names: Carbapenems

Primary outcomes

  1. Clinical and microbiological cure

    Time frame: 5-7 days after end of treatment

    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

Secondary outcomes

  1. Early microbiological eradication

    Time frame: 3-4 days after randomization

    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

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

    Time frame: 60 days after randomization

  3. Length of hospital stay

    Time frame: 60 days after randomization

    Time from randomization to hospital discharge

  4. Persistent cure rate

    Time frame: 60 days after randomization

    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

  5. Clinical recurrences

    Time frame: 60 days after randomization

    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

  6. Mortality

    Time frame: 60 days after randomization

    Death for any reason or for infectious events

  7. Pharmacokinetic of temocillin according to kidney function

    Time frame: 3 days after treatment initiation

    Description of the temocillin plasma concentration and its variability among patients

  8. Microbiota impact study

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

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Fondation Hôpital Saint-Joseph
  • French National Network of Clinical Research in Infectious Diseases (RENARCI)
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: TEMO-CARB

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 1, 2018
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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