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

Last updated: January 21, 2026
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Overall Status: Completed

Phase

3

Condition

Soft Tissue Infections

Sepsis And Septicemia

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).

Patients with polymicrobial bacteremia caused by more than one Enterobacteriaceae species may also be included, provided at least one of them is resistant to third-generation cephalosporins, and both are susceptible to meropenem and temocillin.

  • Duration of intravenous treatment is planned to be at least 4 days fromrandomization, or 3 days if the empirical treatment prior to randomization wasactive.

  • The patient signed informed consent form.

  • Potentially fertile patients must have a negative pregnancy test.

Exclusion

Exclusion Criteria:

  • <18 years

  • Pregnancy

  • Breastfeeding

  • Terminal condition, with life expectancy of less than 30 days, or palliative care ,such that no actions will be taken to control the source of infection if necessary.Patients receiving palliative care with a life expectancy greater than 30 days maybe included if source control is not necessary or, if necessary, will be carriedout.

  • Allergy to betalactams

  • Polymicrobial bacteraemia (except when the other microorganism is considered acontaminant, (e.g. coagulase-negative staphylococci or diphtheroids in a singleblood culture, or in cases where more than one Enterobacteriaceae species isisolated, provided that at least one isolate is resistant to third-generationcephalosporins and both are susceptible to meropenem and temocillin).

  • Infections typically needing prolonged >14 days of therapy (e.g., endocarditis,prosthetic joint infection, vascular graft infection, empyema, chronic prostatitis)or meningitis. Patients who initially do not have a confirmed diagnosis of theseinfections may be included; if the diagnosis is made subsequently, the patient maybe kept in the trial at the discretion of the investigator, establishing theduration of treatment that he considers necessary.

  • 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

Study Design

Total Participants: 334
Treatment Group(s): 2
Primary Treatment: Meropenem
Phase: 3
Study Start date:
December 15, 2020
Estimated Completion Date:
December 26, 2024

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

    Site Not Available

  • Hospital ParcTaulí

    Sabadell 3111199, Barcelona 08208
    Spain

    Site Not Available

  • Hospital Universitario Mútua Terrassa

    Terrassa, Barcelona 08221
    Spain

    Site Not Available

  • Hospital Universitario Mútua Terrassa

    Terrassa 3108286, Barcelona 08221
    Spain

    Site Not Available

  • Hospital Universitario de Cruces

    Barakaldo, Bizkaia 48903
    Spain

    Site Not Available

  • Hospital Universitario de Cruces

    Barakaldo 3109453, Bizkaia 48903
    Spain

    Site Not Available

  • Hospital Marqués de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Marqués de Valdecilla

    Santander 3109718, Cantabria 3336898 39008
    Spain

    Site Not Available

  • Hospital Universitario de Jerez de la Frontera

    Jerez de la Frontera, Cádiz 11407
    Spain

    Site Not Available

  • Hospital Universitario de Jerez de la Frontera

    Jerez de la Frontera 2516326, Cádiz 11407
    Spain

    Site Not Available

  • Hospital Universitario de Puerto Real

    Puerto Real, Cádiz 11510
    Spain

    Site Not Available

  • Hospital Universitario de Puerto Real

    Puerto Real 2512169, Cádiz 11510
    Spain

    Site Not Available

  • Complejo Hospitalario San Millán-San Pedro De La Rioja

    Autol, La Rioja 26560
    Spain

    Site Not Available

  • Complejo Hospitalario San Millán-San Pedro De La Rioja

    Logroño 3118150, La Rioja 3336897 26560
    Spain

    Site Not Available

  • Complejo Hospitalario de Navarra

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Complejo Hospitalario de Navarra

    Pamplona 3114472, Navarre 3115609 31008
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario La Coruña

    A Coruña, 15006
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario La Coruña

    A Coruña 3119841, 15006
    Spain

    Site Not Available

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital General Universitario de Alicante

    Alicante 2521978, 03010
    Spain

    Site Not Available

  • Hospital Universitario Torrecárdenas

    Almería, 04009
    Spain

    Site Not Available

  • Hospital Universitario Torrecárdenas

    Almería 2521886, 04009
    Spain

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Sant Pau

    Barcelona, 08041
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Hospital Sant Pau

    Barcelona 3128760, 08041
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona 3128760, 08003
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofía

    Córdoba, 14004
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofía

    Córdoba 2519240, 14004
    Spain

    Site Not Available

  • Hospital Universitario Clínico San Cecilio

    Granada, 18016
    Spain

    Site Not Available

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014
    Spain

    Site Not Available

  • Hospital Universitario Clínico San Cecilio

    Granada 2517117, 18016
    Spain

    Site Not Available

  • Hospital Universitario Virgen de las Nieves

    Granada 2517117, 18014
    Spain

    Site Not Available

  • Hospital Universitario Juan Ramón Jiménez

    Huelva, 21005
    Spain

    Site Not Available

  • Hospital Universitario Juan Ramón Jiménez

    Huelva 2516548, 21005
    Spain

    Site Not Available

  • Complejo Hospitalario de Jaén

    Jaén, 23007
    Spain

    Site Not Available

  • Hospital Universitario Locus Augusti, Lugo

    Lugo, 27003
    Spain

    Site Not Available

  • Hospital Universitario Locus Augusti, Lugo

    Lugo 3117814, 27003
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Site Not Available

  • 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 General Universitario Gregorio Marañón

    Madrid 3117735, 28007
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid 3117735, 28034
    Spain

    Site Not Available

  • Hospital Universitario de la Princesa

    Madrid 3117735, 28006
    Spain

    Site Not Available

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120
    Spain

    Site Not Available

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia 2513416, 30120
    Spain

    Site Not Available

  • Hospital Regional de Málaga

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Regional de Málaga

    Málaga 2514256, 29010
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria

    Málaga 2514256, 29010
    Spain

    Site Not Available

  • Hospital Universitari Son Espases

    Palma, 07120
    Spain

    Site Not Available

  • Hospital Universitari Son Espases

    Palma 2512989, 07120
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de Valme

    Sevilla, 41014
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Seville 2510911, 41009
    Spain

    Site Not Available

  • Hospital Universitario Virgen de Valme

    Seville 2510911, 41014
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Vigo

    Vigo, 36313
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Vigo

    Vigo 3105976, 36313
    Spain

    Site Not Available

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009
    Spain

    Site Not Available

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