Temocillin versus meropenem for the targeted treatment of bacteraemia due to third-generation cephalosporin-resistant Enterobacterales (ASTARTÉ): protocol for a randomised, pragmatic trial

Temocillin versus meropenem for the targeted treatment of bacteraemia due to third-generation cephalosporin-resistant Enterobacterales (ASTARTÉ): protocol for a randomised, pragmatic trial

IntroductionAlternatives to carbapenems are needed in the treatment of third-generation cephalosporin-resistant Enterobacterales (3GCR-E). Temocillin is a suitable candidate, but comparative randomised studies are lacking. The objective is to investigate if temocillin is non-inferior to carbapenems...

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Bibliographic Details
Published in:BMJ open Vol. 11; no. 9; p. e049481
Main Authors: Marín-Candón, Alicia, Rosso-Fernández, Clara M, Bustos de Godoy, Natalia, López-Cerero, Lorena, Gutiérrez-Gutiérrez, Belén, López-Cortés, Luis Eduardo, Barrera Pulido, Lydia, Borreguero Borreguero, Irene, León, María José, Merino, Vicente, Camean-Fernández, Manuel, Retamar, Pilar, Salamanca, Elena, Pascual, Alvaro, Rodriguez-Baño, Jesús
Format: Journal Article
Language:English
Published: England British Medical Journal Publishing Group 27-09-2021
BMJ Publishing Group LTD
BMJ Publishing Group
Series:Protocol
Subjects:
Antibiotics
Bacteremia - drug therapy
Bacteria
bacteriology
Cephalosporins - pharmacology
clinical pharmacology
Clinical Trials, Phase III as Topic
Drug dosages
Enterobacteriaceae - drug effects
Enzymes
Humans
Hypotheses
infection control
Infections
Infectious Diseases
Informed consent
Meropenem - therapeutic use
microbiology
Multicenter Studies as Topic
Pathogens
Patients
Penicillins - therapeutic use
Pharmacy
Pragmatic Clinical Trials as Topic
Randomized Controlled Trials as Topic
Sepsis
Urogenital system
Spain
microbiology
clinical pharmacology
bacteriology
infection control
infectious diseases
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Summary:IntroductionAlternatives to carbapenems are needed in the treatment of third-generation cephalosporin-resistant Enterobacterales (3GCR-E). Temocillin is a suitable candidate, but comparative randomised studies are lacking. The objective is to investigate if temocillin is non-inferior to carbapenems in the targeted treatment of bacteraemia due to 3GCR-E.Methods and analysisMulticentre, open-label, randomised, controlled, pragmatic phase 3 trial. Patients with bacteraemia due to 3GCR-E will be randomised to receive intravenously temocillin (2 g three times a day) or carbapenem (meropenem 1 g three times a day or ertapenem 1 g once daily). The primary endpoint will be clinical success 7–10 days after end of treatment with no recurrence or death at day 28. Adverse events will be collected; serum levels of temocillin will be investigated in a subset of patients. For a 10% non-inferiority margin, 334 patients will be included (167 in each study arm). For the primary analysis, the absolute difference with one-sided 95% CI in the proportion of patients reaching the primary endpoint will be compared in the modified intention-to-treat population.Ethics and disseminationThe study started after approval of the Spanish Regulatory Agency and the reference institutional review board. Data will be published in peer-reviewed journals.Trial registration numberNCT04478721.
Bibliography:Protocol
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ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2021-049481