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

NCT04478721 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

  • Bacteremia

Interventions

DRUG

Temocillin

The intervention of experimental arm will be Intravenous administration of temocillin.

DRUG

Meropenem

The intervention of comparator arm will be intravenous administration of meropenem.

Sponsors & Collaborators

  • Spanish Network for Research in Infectious Diseases

    collaborator OTHER

  • Spanish Clinical Research Network - SCReN

    collaborator NETWORK

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Jesús Rodriguez Baño · Hospital Universitario Virgen Macarena

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2024-12-26
Completion
2024-12-26

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04478721 on ClinicalTrials.gov