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Pharmacokinetics and safety of aztreonam/avibactam for the treatment of complicated intra-abdominal infections in hospitalized adults: results from the REJUVENATE study
dc.creator | Cornely, Oliver A. | es |
dc.creator | Cisneros, José Miguel | es |
dc.creator | Torre-Cisneros, Julian | es |
dc.creator | Rodríguez-Hernández, María Jesús | es |
dc.creator | Tallón Aguilar, Luis | es |
dc.creator | Calbo, Esther | es |
dc.creator | Padillo Ruiz, Francisco Javier | es |
dc.creator | Jiménez Rodríguez, Rosa M. | es |
dc.creator | Retamar Gentil, Pilar | es |
dc.date.accessioned | 2023-05-19T14:24:23Z | |
dc.date.available | 2023-05-19T14:24:23Z | |
dc.date.issued | 2020 | |
dc.identifier.citation | Cornely, O.A., Cisneros, J.M., Torre-Cisneros, J., Rodríguez-Hernández, M.J., Tallón Aguilar, L., Calbo, E.,...,Retamar Gentil, P. (2020). Pharmacokinetics and safety of aztreonam/avibactam for the treatment of complicated intra-abdominal infections in hospitalized adults: results from the REJUVENATE study. Journal Antimicrobial Chemotherapy, 75, 618-627. https://doi.org/10.1093/jac/dkz497. | |
dc.identifier.issn | 0305-7453 | es |
dc.identifier.issn | 1460-2091 | es |
dc.identifier.uri | https://hdl.handle.net/11441/146462 | |
dc.description.abstract | Objectives: To investigate pharmacokinetics (PK) and safety (primary objectives) and efficacy (secondary objective) of the investigational monobactam/b-lactamase inhibitor combination aztreonam/avibactam in patients with complicated intra-abdominal infection (cIAI). Methods: This Phase 2a open-label, multicentre study (NCT02655419; EudraCT 2015-002726-39) enrolled adults with cIAI into sequential cohorts for 5–14 days treatment. Cohort 1 patients received an aztreonam/avibactam loading dose of 500/137 mg (30 min infusion), followed by maintenance doses of 1500/410 mg (3 h infusions) q6h; Cohort 2 received 500/167 mg (30 min infusion), followed by 1500/500 mg (3 h infusions) q6h. Cohort 3 was an extension of exposure at the higher dose regimen. Doses were adjusted for creatinine clearance of 31–50 mL/min (Cohorts 2!3). All patients received IV metronidazole 500 mg q8h. PK, safety and efficacy were assessed. Results: Thirty-four patients (Cohort 1, n = 16; Cohorts 2!3, n = 18) comprised the modified ITT (MITT) population. Mean exposures of aztreonam and avibactam in Cohorts 2!3 were consistent with those predicted to achieve joint PK/pharmacodynamic target attainment in >90% patients. Adverse events (AEs) were similar between cohorts. The most common AEs were hepatic enzyme increases [n = 9 (26.5%)] and diarrhoea [n = 5 (14.7%)]. Clinical cure rates at the test-of-cure visit overall were 20/34 (58.8%) (MITT) and 14/23 (60.9%) (microbiological-MITT population). Conclusions: Observed AEs were consistent with the known safety profile of aztreonam monotherapy, with no new safety concerns identified. These data support selection of the aztreonam/avibactam 500/167 mg (30 min infusion) loading dose and 1500/500 mg (3 h infusions) maintenance dose q6h regimen, in patients with creatinine clearance >50 mL/min, for the Phase 3 development programm. | es |
dc.format | application/pdf | es |
dc.format.extent | 10 | es |
dc.language.iso | eng | es |
dc.publisher | Oxford University Press | es |
dc.relation.ispartof | Journal Antimicrobial Chemotherapy, 75, 618-627. | |
dc.rights | Atribución-NoComercial 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/4.0/ | * |
dc.subject | Adult | es |
dc.subject | Aztreonam | es |
dc.subject | Metronidazole | es |
dc.subject | Safety | es |
dc.subject | Pharmacokinetics | es |
dc.subject | Liver enzyme | es |
dc.subject | Abdominal infections | es |
dc.subject | Infectious disease of abdomen | es |
dc.subject | Avibactam | es |
dc.title | Pharmacokinetics and safety of aztreonam/avibactam for the treatment of complicated intra-abdominal infections in hospitalized adults: results from the REJUVENATE study | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Cirugía | es |
dc.relation.publisherversion | http://doi.org/10.1093/jac/dkz497 | es |
dc.identifier.doi | 10.1093/jac/dkz497 | es |
dc.journaltitle | Journal Antimicrobial Chemotherapy | es |
dc.publication.volumen | 75 | es |
dc.publication.initialPage | 618 | es |
dc.publication.endPage | 627 | es |