Status:
RECRUITING
Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Resistant to Third Gen Cephalosporins
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborating Sponsors:
Spanish Network for Research in Infectious Diseases
Spanish Clinical Research Network - SCReN
Conditions:
Bacteremia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- \<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
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT04478721
Start Date
December 15 2020
End Date
December 1 2025
Last Update
August 28 2024
Active Locations (34)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
2
Hospital ParcTaulí
Sabadell, Barcelona, Spain, 08208
3
Hospital Universitario Mútua Terrassa
Terrassa, Barcelona, Spain, 08221
4
Hospital Universitario de Cruces
Barakaldo, Bizkaia, Spain, 48903