Ampicillin sodium for Enterococcus faecalis infective endocarditis

Inclusion criteria

• {"criterion_text":"- Adult patients (18 years of age or older)"}
• {"criterion_text":"- Possible or definitive diagnosis of infective endocarditis due to Enterococcus faecalis according to the Duke-ISCVID criteria"}
• {"criterion_text":"- Signed informed consent of patients"}

Exclusion criteria

• {"criterion_text":"- Allergy to penicillins or cephalosporins"}
• {"criterion_text":"- Pregnancy and lactation"}
• {"criterion_text":"- Polymicrobial infection including microorganisms different to E. faecalis"}

Primary endpoints

• {"endpoint_text":"- Treatment failure defined as confirmed recurrence of infective endocarditis due to Enterococcus faecalis (microbiological failure) one year after completion of antibiotic treatment","definition_or_measurement_approach":"Measured as confirmed recurrence of infective endocarditis due to Enterococcus faecalis (microbiological failure) within one year after completion of antibiotic treatment; frequency of disease recurrence is the primary efficacy measure."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured as mortality from any cause during hospitalization or endocarditis-related causes throughout the study, assessed up to one year after treatment completion."}
• {"endpoint_text":"- Number of unplanned cardiac surgeries during the entire study.","definition_or_measurement_approach":"Count of unplanned cardiac surgeries occurring during the study period for each participant."}
• {"endpoint_text":"- Number of unplanned readmissions during the entire trial.","definition_or_measurement_approach":"Count of unplanned hospital readmissions for any reason during the trial period."}
• {"endpoint_text":"- Number of medication-related adverse events from randomisation until 30 days after the last dose administered.","definition_or_measurement_approach":"Count and characterization of medication-related adverse events occurring from randomisation up to 30 days after last dose."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured as total antibiotic treatment days per patient, TADE programme-specific treatment days for applicable patients, and counts of healthcare-associated infections during study follow-up."}
• {"endpoint_text":"- Confirmed recurrence of Enterococcus faecalis infective endocarditis throughout the study.","definition_or_measurement_approach":"Confirmed recurrence events of E. faecalis infective endocarditis recorded during the study period."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Pharmacokinetic sampling on day 14 in the experimental arm to determine minimum free serum concentration and steady-state plasma concentrations over 24 hours for ceftriaxone and ampicillin."}
• {"endpoint_text":"- Pharmacokinetic parameters (volume of distribution, clearance, elimination constant) of ceftriaxone and ampicillin on day 14 after initiation of treatment (visit 2).","definition_or_measurement_approach":"Determination of PK parameters (Vd, clearance, elimination constant) from plasma concentration-time data collected on day 14 (visit 2)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Laboratory measurement of MIC reduction for ampicillin in presence of ceftriaxone for isolates from recurrences and control strains to assess synergistic activity."}

Spain

Earliest CTIS Part Ii Submission Date

15-04-2024

Latest Decision Or Authorization Date

17-02-2026

Processing Time Days

673

Number Of Sites

18

Number Of Participants

284

Primary sponsor

Full Name

Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain