Infective endocarditis
Conditions
Interventions
In this study, enrolled patients will undergo a switch to oral antimicrobial therapy (linezolid plus rifampicin) for the treatment of infective endocarditis. The dose of linezolid will be adjusted as
Sponsors
Machino Tomoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Intervention Group 1) Patients aged 18 years or older. 2) Patients diagnosed with infective endocarditis based on the modified Duke criteria, caused by streptococci, enterococci, Staphylococcus aureus, or coagulase-negative staphylococci. 3) Patients who have received at least 10 days of intravenous antimicrobial therapy (or at least 7 days if post-surgical). 4) Patients with a stable body temperature below 37.5 degrees Celsius for at least two consecutive days following the initiation of intravenous antimicrobial therapy. 5) Patients whose C-reactive protein (CRP) level has decreased less than or equal to 25% of the peak value or is <2 mg/dL after starting intravenous antimicrobial therapy. 6) Patients with a white blood cell count of <15,000/microliter after initiation of intravenous antimicrobial therapy. 7) Patients in whom negative blood cultures have been confirmed following the initiation of intravenous antimicrobial therapy. 8) Patients without progressive valvular destruction or abscess formation on transthoracic and transesophageal echocardiography performed within 7 days prior to enrollment. 9) Patients not requiring surgical intervention for the treatment of infective endocarditis. 10) Patients with a peripheral platelet count greater than or equal to 75,000/microliter in blood tests conducted within 3 days before starting oral antimicrobial therapy (linezolid plus rifampicin). 11) Patients enrolled after providing written informed consent voluntarily, by themselves or their legally authorized representatives, based on sufficient explanation and understanding of the study. Control Group 1) Patients who received intravenous antimicrobial therapy for infective endocarditis at the University of Tsukuba Hospital between January 2008 and December 2024. 2) Patients aged 18 years or older. 3) Patients diagnosed with infective endocarditis based on the modified Duke criteria, caused by streptococci, enterococci, Staphylococcus aureus, or coagulase-negative staphylococci.
Exclusion criteria
Exclusion criteria: Intervention Group 1) Patients with other pre-existing conditions requiring intravenous antimicrobial therapy. 2) Patients unable to take medications orally. 3) Patients suspected of having gastrointestinal absorption disorders. 4) Patients with severe hepatic impairment (Child-Pugh classification grade C). 5) Patients with severe renal dysfunction (eGFR < 30 mL/min/1.73 m^2). 6) Patients with a BMI over 40. 7) Patients with known allergies to linezolid or rifampicin. 8) Patients deemed inappropriate for study participation by the principal or sub-investigator. Control Group 1) Patients with severe hepatic impairment (Child-Pugh classification grade C). 2) Patients with severe renal dysfunction (eGFR < 30 mL/min/1.73 m^2). 3) Patients with a BMI over 40. 4) Patients who declined participation in this opt-out study, either personally or through a request from their family members.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite endpoint includes the following outcomes occurring from the initiation of oral antimicrobial therapy (linezolid plus rifampicin) to six months after its completion: 1) All-cause mortality 2) Unplanned cardiac surgery 3) Symptomatic embolic events (confirmed as embolic in nature based on imaging findings) 4) Recurrence of bacteremia caused by the pathogen responsible for infective endocarditis | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Proportion of treatment discontinuation due to adverse events during oral antimicrobial therapy 2) Duration of oral antimicrobial therapy 3) Incidence of adverse effects related to oral antimicrobial therapy 4) Serum linezolid concentrations 5) Echocardiographic findings before enrollment and at the end of the observation period (size of vegetation, severity of valvular disease, and cardiac function) | — |
Contacts
Public Contacttomoko machino
University of Tsukuba Hospital
Outcome results
None listed