Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Resistant to Third Gen Cephalosporins
NCT ID: NCT04478721
Last Updated: 2024-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
334 participants
INTERVENTIONAL
2020-12-15
2025-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Temocillin
Patients enrolled in this arm, will receive 2g each 8 hours of intravenous temocillin.
Temocillin
The intervention of experimental arm will be Intravenous administration of temocillin.
Meropenem
Patients enrolled in this arm, will receive 1g each 8 hours of intravenous meropenem.
Meropenem
The intervention of comparator arm will be intravenous administration of meropenem.
Interventions
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Temocillin
The intervention of experimental arm will be Intravenous administration of temocillin.
Meropenem
The intervention of comparator arm will be intravenous administration of meropenem.
Eligibility Criteria
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Inclusion Criteria
* Duration of intravenous treatment is planned to be at least 4 days.
* The patient signed informed consent form.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Spanish Network for Research in Infectious Diseases
OTHER
Spanish Clinical Research Network - SCReN
NETWORK
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Jesús Rodriguez Baño
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen Macarena
Locations
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Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
Hospital ParcTaulí
Sabadell, Barcelona, Spain
Hospital Universitario Mútua Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario de Cruces
Barakaldo, Bizkaia, Spain
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital Universitario de Puerto Real
Puerto Real, Cádiz, Spain
Complejo Hospitalario San Millán-San Pedro De La Rioja
Autol, La Rioja, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Complejo Hospitalario Universitario La Coruña
A Coruña, , Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Universitario Torrecárdenas
Almería, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital Sant Pau
Barcelona, , Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Universitario Clínico San Cecilio
Granada, , Spain
Hospital Universitario Juan Ramón Jiménez
Huelva, , Spain
Complejo Hospitalario de Jaén
Jaén, , Spain
Hospital Universitario Locus Augusti, Lugo
Lugo, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional de Málaga
Málaga, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, , Spain
Hospital Universitari Son Espases
Palma, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitario Virgen de Valme
Seville, , Spain
Complejo Hospitalario Universitario de Vigo
Vigo, , Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Marin-Candon A, Rosso-Fernandez CM, Bustos de Godoy N, Lopez-Cerero L, Gutierrez-Gutierrez B, Lopez-Cortes LE, Barrera Pulido L, Borreguero Borreguero I, Leon MJ, Merino V, Camean-Fernandez M, Retamar P, Salamanca E, Pascual A, Rodriguez-Bano J; ASTARTE Study Group. Temocillin versus meropenem for the targeted treatment of bacteraemia due to third-generation cephalosporin-resistant Enterobacterales (ASTARTE): protocol for a randomised, pragmatic trial. BMJ Open. 2021 Sep 27;11(9):e049481. doi: 10.1136/bmjopen-2021-049481.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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2020-000064-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ASTARTÉ
Identifier Type: -
Identifier Source: org_study_id
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