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Temocilin vs meropenem for the treatment of infections due to Enterobacteriales
EU CTIS ID: 2023-508440-21-00
What this study is testing
To demonstrate the non-inferiority of temocillin to carbapenems in terms of efficacy and safety in the targeted treatment of bacteraemia due to Enterobacterales resistant to third-generation cephalosporins, and therefore provide evidence for the use of temocillin in these infections.
- 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
- Hospitalized adult patients (18 years or older) who present bacteremia of any origin with monomicrobial isolation of Enterobacterales in blood culture; Patients with polymicrobial bacteremia caused by more than one enterobacteria may also be included, with at least one of them being resistant to third-generation cephalosporins (see next point), and both being sensitive to meropenem and temocillin.
- The microorganism is resistant to third generation cephalosporins: cefotaxime, ceftriaxone (MIC > 2 mg/L) and/or ceftazidime (MIC > 4 mg/L).
- The microorganism is sensitive to temocillin (MIC ≤8 mg/L, except in bacteremia of urinary origin only, for which the criterion is MIC ≤16 mg/L) and meropenem (MIC ≤2 mg/L).
- Patients in whom, once diagnosed with potentially includable Enterobacterales bacteremia, the need to maintain intravenous treatment is estimated for at least 4 days from randomization, or 3 days if empirical treatment prior to randomization was appropriate.
- Patients who have signed the informed consent.
- Potentially fertile patients must have a negative pregnancy test.
You likely can't join if
- Minors under 18 years of age.
- Terminal situation, or estimated life expectancy of less than 30 days, or under purely palliative treatment for their underlying illness, so that necessary actions will not be taken to control the focus of infection if necessary. Patients in palliative care and with a life expectancy greater than 30 days may be included, in which control of the focus is not necessary or, if necessary, will be carried out.
- Pregnant or breastfeeding women.
- Known allergy or hypersensitivity to beta-lactams
- Polymicrobial bacteremia (except when the other microorganism is considered a contaminant, such as coagulase-negative staphylococci or diphtheroids in a single extraction, or in the case of isolation of more than one enterobacteria, provided that the criterion that at least one of them is resistant to third generation cephalosporins, and both sensitive to meropenem and temocillin).
- Delay in inclusion greater than 48 hours after having the antibiotic sensitivity data of the Enterobacteriaceae isolated in blood culture, or who have received active empirical treatment for more than 96 hours after the initial blood culture was obtained.
See the full eligibility criteria
Who can join
- Hospitalized adult patients (18 years or older) who present bacteremia of any origin with monomicrobial isolation of Enterobacterales in blood culture; Patients with polymicrobial bacteremia caused by more than one enterobacteria may also be included, with at least one of them being resistant to third-generation cephalosporins (see next point), and both being sensitive to meropenem and temocillin.
- The microorganism is resistant to third generation cephalosporins: cefotaxime, ceftriaxone (MIC > 2 mg/L) and/or ceftazidime (MIC > 4 mg/L).
- The microorganism is sensitive to temocillin (MIC ≤8 mg/L, except in bacteremia of urinary origin only, for which the criterion is MIC ≤16 mg/L) and meropenem (MIC ≤2 mg/L).
- Patients in whom, once diagnosed with potentially includable Enterobacterales bacteremia, the need to maintain intravenous treatment is estimated for at least 4 days from randomization, or 3 days if empirical treatment prior to randomization was appropriate.
- Patients who have signed the informed consent.
- Potentially fertile patients must have a negative pregnancy test.
What rules you out
- Minors under 18 years of age.
- Terminal situation, or estimated life expectancy of less than 30 days, or under purely palliative treatment for their underlying illness, so that necessary actions will not be taken to control the focus of infection if necessary. Patients in palliative care and with a life expectancy greater than 30 days may be included, in which control of the focus is not necessary or, if necessary, will be carried out.
- Pregnant or breastfeeding women.
- Known allergy or hypersensitivity to beta-lactams
- Polymicrobial bacteremia (except when the other microorganism is considered a contaminant, such as coagulase-negative staphylococci or diphtheroids in a single extraction, or in the case of isolation of more than one enterobacteria, provided that the criterion that at least one of them is resistant to third generation cephalosporins, and both sensitive to meropenem and temocillin).
- Delay in inclusion greater than 48 hours after having the antibiotic sensitivity data of the Enterobacteriaceae isolated in blood culture, or who have received active empirical treatment for more than 96 hours after the initial blood culture was obtained.
- Infections that typically have a recommended treatment duration of more than 14 days (endocarditis, osteomyelitis, prosthetic infection, chronic prostatitis, empyema...), or meningitis. Patients who initially do not have a confirmed diagnosis of these infections may be included; If their diagnosis is made later, the patient may be kept in the trial at the discretion of the researcher, establishing the duration of treatment that is considered necessary.
- Peritoneal dialysis or continuous hemofiltration.
- Patients who are participating in another clinical trial with active treatment.
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.