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Comparing Temocillin and Meropenem for Treating Resistant Bacteraemia

Randomised Controlled Trial of Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Due to Enterobacteriaceae Showing Resistance to Third Generation Cephalosporins

Phase 3 Interventional Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · NCT04478721

This study is testing if temocillin works as well and is just as safe as meropenem for treating blood infections caused by certain resistant bacteria in adults.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment334 (estimated)
Ages18 Years and up
SexAll
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla Academic / other
Locations34 sites (Santiago de Compostela, A Coruña and 33 other locations)
Trial IDNCT04478721 on ClinicalTrials.gov

What this trial studies

This Phase 3, multicenter, randomized, controlled, open-label trial aims to demonstrate that temocillin is as effective and safe as meropenem for treating bacteraemia caused by Enterobacteriaceae resistant to third-generation cephalosporins. Adult patients with monomicrobial bacteremia will receive either temocillin or meropenem for a treatment duration of 7 to 14 days, with the possibility of transitioning to oral treatment after the fifth day if conditions are met. The study will assess the efficacy and safety of temocillin compared to the standard carbapenem treatment.

Who should consider this trial

Good fit: Ideal candidates are adults with monomicrobial bacteremia due to Enterobacteriaceae resistant to third-generation cephalosporins but sensitive to temocillin and meropenem.

Not a fit: Patients with polymicrobial bacteremia or those requiring prolonged therapy for specific infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with difficult-to-treat infections caused by resistant bacteria.

How similar studies have performed: Other studies have shown promising results with temocillin in similar contexts, but this specific comparison with meropenem is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Adult patients with monomicrobial bacteremia due to Enterobacteriaceae showing resistance to cefotaxime, ceftriaxone (MIC \>2 mg/L) and/or ceftazidime (MIC \>4 mg/L), and sensible to temocillin (MIC ≤8 mg/L, except in bacteremia only of urinary origin, for which the criterion is MIC ≤16 mg/L ) and meropenem (MIC ≤2 mg/L).
* Duration of intravenous treatment is planned to be at least 4 days.
* The patient signed informed consent form.

Exclusion Criteria:

* \<18 years
* Pregnancy
* Breastfeeding
* Palliative care
* Allergy to betalactams
* Polymicrobial bacteraemia
* Infections typically needing prolonged \>14 days of therapy (e.g., endocarditis, prosthetic joint infection, vascular graft infection, empyema, chronic prostatitis) or meningitis
* Active empirical treatment\> 96 hours after initial blood culture extraction
* Delay in inclusion\> 48 h
* Recruited in another clinical trial with active treatment
* Peritoneal dialysis or continuous hemofiltration
* extreme gravity or imminent death

Where this trial is running

Santiago de Compostela, A Coruña and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions BacteremiaBacteraemiaEnterobacteriaceaeTemocillinThird-generation cephalosporin-resistant Enterobacteriaceae.
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.