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

NCT03543436 | Completed Phase 3 DMC

• 2 other identifiers: P 160910J2017-001257-14
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Urinary Tract Infections

Keywords

Non-inferiority study; Temocillin; Carbapenem; ESBL infection; Urinary tract infection

Outcome Measures

Primary Outcomes (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

  5-7 days after end of treatment

Secondary Outcomes (8)

• Early microbiological eradication

  3-4 days after randomization

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

  60 days after randomization

• Length of hospital stay

  60 days after randomization

• Persistent cure rate

  60 days after randomization

• Clinical recurrences

  60 days after randomization

Study Arms (2)

Intravenous temocillin

EXPERIMENTAL

Intravenous temocillin 2g/intravenously/8h or renally adjusted equivalent (ORAE) in 30-40 min infusion or continuous intravenous (6g/24h)

Drug: Temocillin

Intravenous meropenem or imipenem

ACTIVE COMPARATOR

Intravenous meropenem or imipenem 1g/Intravenously /8h ORAE in 15-30 min infusion. Then switch to oral therapy

Drug: meropenem or imipenem

Interventions

Temocillin DRUG

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

Intravenous temocillin

meropenem or imipenem DRUG

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

Also known as: Carbapenems

Intravenous meropenem or imipenem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fondation Hôpital Saint-Joseph: collaborator
• French National Network of Clinical Research in Infectious Diseases (RENARCI): collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (16)

CHU de Martinique

Fort-de-france, Martinique, France

Location

CHRU La Cavale Blanche

Brest, 29000, France

Location

CHU de Grenoble Hospital

Grenoble, France

Location

Melun Hospital - CHU Sud

Melun, 77, France

Location

APHP - Cochin Hospital

Paris, 75014, France

Location

APHP - Necker-Enfants maladies Hospital

Paris, 75015, France

Location

Bichat hospital

Paris, 75018, France

Location

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, 75020, France

Location

Tenon Hospital

Paris, 75020, France

Location

APHP - Beaujon Hospital

Paris, France

Location

APHP - Georges Pompidou European Hospital

Paris, France

Location

APHP - Saint-Antoine Hospital

Paris, France

Location

Saint-Joseph Hospital

Paris, France

Location

CHU de Pau

Pau, France

Location

CHU de Poitiers

Poitiers, France

Location

CHU Pontchaillou

Rennes, 35000, France

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

temocillin; Meropenem; Imipenem; Carbapenems

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thienamycins; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Benoit PILMIS, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Olivier LORTHOLARY, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 1, 2018
• Study Start: January 4, 2019
• Primary Completion: October 29, 2020
• Study Completion: December 14, 2020
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (16)