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Trial record 6 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

Temocillin Versus a Carbapenem as Initial Intravenous Treatment for ESBL Related Urinary Tract Infections (TEMO-CARB)

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ClinicalTrials.gov Identifier: NCT03543436
Recruitment Status : Not yet recruiting
First Posted : June 1, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
Groupe Hospitalier Paris Saint Joseph
French National Network of Clinical Research in Infectious Diseases (RENARCI)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Drug: Temocillin Drug: meropenem or imipenem Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Temocillin Versus a Carbapenem as Initial Intravenous Treatment for Extended-spectrum Beta-lactamase Related Urinary Tract Infections, a Non-inferiority Study
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intravenous temocillin
Intravenous temocillin 2g/intravenously/8h or renally adjusted equivalent (ORAE) in 30-40 min infusion
Drug: Temocillin
Intravenous temocillin disodium 2g intravenously/8h Or Renally Adjusted Equivalent (ORAE) in 30-40 min infusion.

Active Comparator: Intravenous meropenem or imipenem
Intravenous meropenem or imipenem 1g/Intravenously /8h ORAE in 15-30 min infusion. Then switch to oral therapy
Drug: meropenem or imipenem
Intravenous carbapenem (meropenem 1g intravenously/8h Or Renally Adjusted Equivalent (ORAE) or imipenem 1g intravenously/8h ORAE)
Other Name: Carbapenems




Primary Outcome Measures :
  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 < 103 CFU/mL of the baseline pathogens



Secondary Outcome Measures :
  1. Early microbiological eradication [ Time Frame: 3-4 days after randomization ]
    Microbiological eradication will be assessed by quantitative urine culture and defined as follows < 103 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Patient affiliated to the social security system

Exclusion Criteria:

  • Patient infected with a bacteria which is not an ESBL-producing enterobacteriaceae.
  • Patient infected with a strain resistant to temocillin.
  • 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.
  • Delay in randomization > 24 hours after identification of ESBL producing enterobacteriaceae in urinary and/or blood culture.
  • Participation in other clinical trial for the infection.
  • Patient under guardianship or wardship.
  • Patient unable to give consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543436


Contacts
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Contact: Benoit PILMIS, MD +33-(0)1-42-19-26-63 bpilmis@gmail.com
Contact: Prissile BAKOUBOULA, PhD +33 1 71 19 64 94 prissile.bakouboula@aphp.fr

Locations
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France
CHU de Martinique Not yet recruiting
Fort-de-france, Martinique, France
Principal Investigator: André CABIE, MD, PhD         
CHU de Grenoble Hospital
Grenoble, France
CHRU de Lille Not yet recruiting
Lille, France, 59000
Principal Investigator: Fanny VUOTTO, MD         
APHP - Cochin Hospital
Paris, France, 75014
APHP - Necker-Enfants maladies Hospital Not yet recruiting
Paris, France, 75015
Principal Investigator: Olivier LORTHOLARY, MD, PhD         
Sub-Investigator: Benoit PILMIS, MD         
APHP - Beaujon Hospital
Paris, France
APHP - Georges Pompidou European Hospital Not yet recruiting
Paris, France
Principal Investigator: David LEBEAUX, MD, PhD         
APHP - Saint-Antoine Hospital Not yet recruiting
Paris, France
Principal Investigator: Laure SURGERS, Md, PhD         
Saint-Joseph Hospital Not yet recruiting
Paris, France
Principal Investigator: Benoit PILMIS, MD         
CHU de Pau Not yet recruiting
Pau, France
Principal Investigator: Valérie GABORIEAU, MD         
CHU de Poitiers Not yet recruiting
Poitiers, France
Principal Investigator: Blandine RAMMAERT, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Groupe Hospitalier Paris Saint Joseph
French National Network of Clinical Research in Infectious Diseases (RENARCI)
Investigators
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Principal Investigator: Benoit PILMIS, MD, PhD Assistance Publique - Hôpitaux de Paris
Study Chair: Olivier LORTHOLARY, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03543436     History of Changes
Other Study ID Numbers: P 160910J
2017-001257-14 ( EudraCT Number )
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Non-inferiority study
Temocillin
Carbapenem
ESBL infection
Urinary tract infection

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Meropenem
Imipenem
Temocillin
Penicillins
Anti-Bacterial Agents
Anti-Infective Agents