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Piperacillin-tazobactam and temocillin as carbapenem-alternatives for the treatment of severe infections due to extended-spectrum beta-lactamase–producing Gram-negative Enterobacteriaceae in the intensive care unit (PITAGORE)
EU CTIS ID: 2024-511866-36-00
What this study is testing
The primary objective of the study is to demonstrate that among patients hospitalized in ICU with ESBL-producing Enterobacteriaceae severe infection, a treatment with a carbapenem-sparing agent (piperacillin/tazobactam or temocillin) is non-inferior to a carbapenem in terms of mortality.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients ≥ 18-year-old
- Hospitalized in the ICU
- Severe infection, eg infection in patient hospitalized in ICU with or without sepsis or septic shock (according to the Sepsis-3 definition) If present sepsis or septic shock have to be fulfilled within a time frame of +/- 24 hours from the day of infection diagnosis (i.e. the day of positive bacteriological sample).
- Pathogen responsible for infection is an ESBL-producing Enterobacteriaceae susceptible to meropenem and either to piperacillin/tazobactam (minimum inhibitory concentration <8 mg/L) or to temocillin (minimum inhibitory concentration ≤8 mg/L)
- Signed Informed consent from patient/a legal representative/a family member/a close relative. According to the specifications of emergency inclusion, randomization without the close relative or surrogate consent could be performed if the patient is unable to give his/her consent and when the legal representative/family member or close relative are absent except patients included in another study for which emergency inclusion has already been used (see exclusion criteria n° 8). For these patients, emergency inclusion cannot be used) close relative/surrogate/family consent will be asked as soon as possible. The patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow
- Affiliation to social security (AME excluded)
You likely can't join if
- Pregnancy or breastfeeding
- Known allergy to beta-lactam
- Patient with severe neutropenia, as defined by absolute neutrophil count <0.5x109/L
- Infection requiring prolonged antimicrobial treatment (endocarditis; mediastinitis; osteomyelitis/septic arthritis; undrainable/undrained abscess; unremovable/unremoved prosthetic-associated infection)
- Moribund, defined by a SAPS II score at inclusion >75
- Decision of withholding/withdrawing care
See the full eligibility criteria
- Patients ≥ 18-year-old
- Hospitalized in the ICU
- Severe infection, eg infection in patient hospitalized in ICU with or without sepsis or septic shock (according to the Sepsis-3 definition) If present sepsis or septic shock have to be fulfilled within a time frame of +/- 24 hours from the day of infection diagnosis (i.e. the day of positive bacteriological sample).
- Pathogen responsible for infection is an ESBL-producing Enterobacteriaceae susceptible to meropenem and either to piperacillin/tazobactam (minimum inhibitory concentration <8 mg/L) or to temocillin (minimum inhibitory concentration ≤8 mg/L)
- Signed Informed consent from patient/a legal representative/a family member/a close relative. According to the specifications of emergency inclusion, randomization without the close relative or surrogate consent could be performed if the patient is unable to give his/her consent and when the legal representative/family member or close relative are absent except patients included in another study for which emergency inclusion has already been used (see exclusion criteria n° 8). For these patients, emergency inclusion cannot be used) close relative/surrogate/family consent will be asked as soon as possible. The patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow
- Affiliation to social security (AME excluded)
- Pregnancy or breastfeeding
- Known allergy to beta-lactam
- Patient with severe neutropenia, as defined by absolute neutrophil count <0.5x109/L
- Infection requiring prolonged antimicrobial treatment (endocarditis; mediastinitis; osteomyelitis/septic arthritis; undrainable/undrained abscess; unremovable/unremoved prosthetic-associated infection)
- Moribund, defined by a SAPS II score at inclusion >75
- Decision of withholding/withdrawing care
- Patient with concomitant infection requiring antibiotics with activity against Gram-negative bacilli, including patient with polymicrobial infection with pathogen resistant to study drugs
- Participation in another interventional study evaluating drugs or being in the exclusion period at the end of a previous study evaluating drugs.
- Hypersensitivity to any components of the formulations
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.