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

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Meropenem; Temocillin

Criteria

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