Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Resistant to Third Gen Cephalosporins

  • STATUS
    Recruiting
  • End date
    Sep 20, 2023
  • participants needed
    334
  • sponsor
    Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Updated on 20 October 2021
antibiotics
ceftriaxone
carbapenem
ceftazidime
meropenem
cephalosporins

Summary

A Phase 3, Multicenter, Randomised, Controlled, Open-Label Study to demonstrate noninferiority of temocillin (unauthorized investigational medicinal product IMP in Spain, but authorized in Belgium and UK) vs a carbapenem antibiotic (meropenem) in adults with bacteraemia due to third-generation cephalosporin-resistant Enterobacteriaceae.

The duration of treatment will be between 7 and 14 days. From the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.

Description

The objective of the trial is to demonstrate the non-inferiority of temocillin (2g each 8 hours, intravenous) to carbapenems (meropenem 1g each 8 hours, intravenous) in terms of efficacy and safety in the targeted treatment of bacteraemia due to Enterobacteriaceae resistant to third-generation cephalosporins, and therefore provide evidence for the use of temocillin in these infections.

The duration of treatment will be between 7 and 14 days. From the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.

Details
Condition Septicemia, bacteraemia, Sepsis and Septicemia, Bacteremia, Bacterial Infections, Bacterial Infection, blood poisoning
Treatment Meropenem, Temocillin
Clinical Study IdentifierNCT04478721
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla
Last Modified on20 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients with monomicrobial bacteraemia due to Enterobacteriaceae showing resistance to cefotaxime, ceftriaxone (MIC >2 mg/L) and/or ceftazidime (MIC >4 mg/L), ands sensible to temocillin (MIC 8 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
Meningitis
Infections typically needing prolonged >14 days of therapy (e.g., endocarditis, prosthetic joint infection, vascular graft infection, empyema, chronic prostatitis)
Severe neutropenia
Shock
Active empirical treatment> 96 hours after initial blood culture extraction
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