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

Last updated: August 27, 2024
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Overall Status: Active - Recruiting

Phase

3

Condition

Sepsis And Septicemia

Soft Tissue Infections

Treatment

Meropenem

Temocillin

Clinical Study ID

NCT04478721
ASTARTÉ
2020-000064-39
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients with monomicrobial bacteremia due to Enterobacteriaceae showingresistance to cefotaxime, ceftriaxone (MIC >2 mg/L) and/or ceftazidime (MIC >4mg/L), and sensible to temocillin (MIC ≤8 mg/L, except in bacteremia only of urinaryorigin, 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

Exclusion Criteria:

  • <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

Study Design

Total Participants: 334
Treatment Group(s): 2
Primary Treatment: Meropenem
Phase: 3
Study Start date:
December 15, 2020
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Hospital Clínico Universitario de Santiago

    Santiago de Compostela, A Coruña 15706
    Spain

    Site Not Available

  • Hospital ParcTaulí

    Sabadell, Barcelona 08208
    Spain

    Active - Recruiting

  • Hospital Universitario Mútua Terrassa

    Terrassa, Barcelona 08221
    Spain

    Active - Recruiting

  • Hospital Universitario de Cruces

    Barakaldo, Bizkaia 48903
    Spain

    Active - Recruiting

  • Hospital Marqués de Valdecilla

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Hospital Universitario de Jerez de la Frontera

    Jerez de la Frontera, Cádiz 11407
    Spain

    Active - Recruiting

  • Hospital Universitario de Puerto Real

    Puerto Real, Cádiz 11510
    Spain

    Active - Recruiting

  • Complejo Hospitalario San Millán-San Pedro De La Rioja

    Autol, La Rioja 26560
    Spain

    Active - Recruiting

  • Complejo Hospitalario de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario La Coruña

    A Coruña, 15006
    Spain

    Active - Recruiting

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Active - Recruiting

  • Hospital Universitario Torrecárdenas

    Almería, 04009
    Spain

    Active - Recruiting

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofía

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Hospital Universitario Clínico San Cecilio

    Granada, 18016
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014
    Spain

    Site Not Available

  • Hospital Universitario Juan Ramón Jiménez

    Huelva, 21005
    Spain

    Active - Recruiting

  • Complejo Hospitalario de Jaén

    Jaén, 23007
    Spain

    Site Not Available

  • Hospital Universitario Locus Augusti, Lugo

    Lugo, 27003
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario de la Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120
    Spain

    Active - Recruiting

  • Hospital Regional de Málaga

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitari Son Espases

    Palma, 07120
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de Valme

    Sevilla, 41014
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario de Vigo

    Vigo, 36313
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009
    Spain

    Site Not Available

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