infective endocarditis
Conditions
Interventions
Trade Name: BENZETACIL 2.400.000
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: BENZYLPENICILLIN SODIUM
CAS Nu
Sponsors
Carmen Olmos Blanco
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Definite IE, according to modified ESC 2015 criteria, caused by gram-positive cocci (staphylococci, streptococci and enterococci), including native, prosthetic valve IE and cardiac device-related IE. •I8 years old or older. •Absence of fever, microbiological or analytical findings suggesting persistent infection after 24h of randomization. •Absence of locally uncontrolled infection signs (abscess, pseudoaneurysm, fistula, enlarging vegetation) at randomization, confirmed by recent transesophageal echocardiography (performed within 48 h of randomization). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 204
Exclusion criteria
Exclusion criteria: •Patients who recived more than 12 days of target antibiotic treatament to infective endocarditis •Patients not suitable to be discharged after randomization, due to clinical reasons (sequels of stroke that prevent discharge, progressive renal failure, hepatic failure). •Patients with immunosuppressive therapy or chemotherapy •Pregnant and breastfeeding women. •Need of prolonged antibiotic therapy due to spondylodiscitis. •Absence of patient’s ability or commitment to continue follow-up after being discharged from hospital. •Inability to give informed consent to participation. •Cognitive impairment or Spanish unknowledge •Patients candidate to cardiac surgery considered unoperable due to high surgical risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the incidence of the composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion, between patients with IE caused by gram-positive cocci receiving a short course of 2 weeks of antibiotic therapy and those patients receiving conventional antibiotic therapy for 4-6 weeks.; Secondary Objective: 1. Is superior compared to conventional antibiotic treatment regarding the perceived quality of life in the 4 weeks after the inclusion in the study. 2. Is superior compared to conventional antibiotic treatment regarding the functional performance in the 4 weeks after the inclusion in the study. 3. Diminish the risk of clinical complications related to prolonged hospital stay (nosocomial infections, intravascular catheter-related infections), compared to conventional antibiotic treatment. 4. Diminish total hospital length of stay in the next 6 months after the inclusion in the study, compared to conventional antibiotic treatment. 5. Diminish with conventional antibiotic tetrament is more cost effectiveness ; Primary end point(s): Composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms, and relapse by the index pathogen within 6 months after the intervention. Unplanned cardiac surgery is defined as surgery of the heart not planned before randomization. Surgery due to sterile pericardial effusion or hemorrhage is not included. Embolic events are defined as any symptomatic embolic event that occurs after randomization. Relapse is defined as the finding of any blood culture positive with the primary pathogen or appearance or progression of typical echocardiographic findings of IE (new appearance or enlargement of a vegetation, appearance of new periannular complications). ;Timepoint(s) of eva | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Perceived quality of life. We will measure changes in the mean score of SF-12 between the time of randomization, 4 weeks after and 6 month. - Functional performance. We will measure changes the change in the mean score of short performance physical battery test (SPPB) between the time of randomization and 4 weeks after. - Total hospital length of stay in the next 6 months after the inclusion in the study, including admissions related or not related to IE. - Total cost per patient. - Clinical complications ap to 6 month after randomization. ;Timepoint(s) of evaluation of this end point: 6 month | — |
Countries
Spain
Contacts
Public ContactCarmen Olmos Blanco
Hospital Clinico San Carlos
Outcome results
None listed