Efficay and safety of ampicillin and ceftriaxone continuous infusion versus standard therapy for the treatment of Enterococcus faecalis infective endocarditis (DOβLEI Study)

Conditions

Enterococcus faecalis infectious endocarditis

Brief summary

Treatment failure defined as confirmed recurrence of infective endocarditis due to Enterococcus faecalis (microbiological failure) one year after completion of antibiotic treatment

Detailed description

Treatment failure assessed up to one year after completion of treatment and defined as follows: mortality (therapeutic failure) from any cause during hospitalization or from endocarditis-related causes throughout the study., Number of unplanned cardiac surgeries during the entire study., Number of unplanned readmissions during the entire trial., Number of medication-related adverse events from randomisation until 30 days after the last dose administered., Total number of antibiotic treatment days, number of TADE treatment days in those patients who receive continuous infusion (experimental arm) and their site has a TADE programme, and number of healthcare-associated infections throughout the trial., Confirmed recurrence of Enterococcus faecalis infective endocarditis throughout the study., Minimum free serum concentration and steady-state plasma concentration of ceftriaxone and ampicillin for 24 hours on day 14 after initiation of treatment (visit 2) in the experimental arm., Pharmacokinetic parameters (volume of distribution, clearance, elimination constant) of ceftriaxone and ampicillin on day 14 after initiation of treatment (visit 2)., Synergistic activity will be calculated through the reduction of the Minimum Inhibitory Concentration of ampicillin induced by ceftriaxone in the strains responsible for recurrences and control strains.

Related papers

No related papers found yet.

Interventions

DRUGLinezolid Teva Pharma 600 mg comprimidos recubiertos con película EFG

DRUGMoxifloxacino Sandoz 400 mg comprimidos recubiertos con película EFG

DRUGTeicoplanina Sala 200 mg polvo para solución inyectable y para perfusión EFG.

DRUGAMPICILLIN

DRUGAmoxicilina Teva 1.000 mg comprimidos EFG

DRUGCEFTRIAXONE

DRUGRifaldin 300 mg cápsulas

DRUGDaptomicina Accord 500 mg polvo para solución inyectable y para perfusión EFG

DRUGLinezolid Demo 2 mg/ml solución para perfusión EFG

DRUGDalbavancina Sala 500 mg polvo para concentrado para solución para perfusión EFG

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Treatment failure defined as confirmed recurrence of infective endocarditis due to Enterococcus faecalis (microbiological failure) one year after completion of antibiotic treatment	—

Secondary

Measure	Time frame
Treatment failure assessed up to one year after completion of treatment and defined as follows: mortality (therapeutic failure) from any cause during hospitalization or from endocarditis-related causes throughout the study., Number of unplanned cardiac surgeries during the entire study., Number of unplanned readmissions during the entire trial., Number of medication-related adverse events from randomisation until 30 days after the last dose administered., Total number of antibiotic treatment days, number of TADE treatment days in those patients who receive continuous infusion (experimental arm) and their site has a TADE programme, and number of healthcare-associated infections throughout the trial., Confirmed recurrence of Enterococcus faecalis infective endocarditis throughout the study., Minimum free serum concentration and steady-state plasma concentration of ceftriaxone and ampicillin for 24 hours on day 14 after initiation of treatment (visit 2) in the experimental arm., Pharmacok	—

Measure

Time frame

Treatment failure assessed up to one year after completion of treatment and defined as follows: mortality (therapeutic failure) from any cause during hospitalization or from endocarditis-related causes throughout the study., Number of unplanned cardiac surgeries during the entire study., Number of unplanned readmissions during the entire trial., Number of medication-related adverse events from randomisation until 30 days after the last dose administered., Total number of antibiotic treatment days, number of TADE treatment days in those patients who receive continuous infusion (experimental arm) and their site has a TADE programme, and number of healthcare-associated infections throughout the trial., Confirmed recurrence of Enterococcus faecalis infective endocarditis throughout the study., Minimum free serum concentration and steady-state plasma concentration of ceftriaxone and ampicillin for 24 hours on day 14 after initiation of treatment (visit 2) in the experimental arm., Pharmacok

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Countries

Spain

Outcome results

None listed