Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Resistant to Third Gen Cephalosporins
Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators:
SCReN Spanish research Network- CTU-HUVR Spanish Network for Research in Infectious Diseases