Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-24 @ 6:58 PM
NCT ID:
NCT04222257
Eligibility 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.
* 18 years old or older.
* Patients treated for at least 10 days of appropriate parenteral antibiotic therapy overall (according to guidelines and microbiology sensitivity testing), and at least 7 days of parenteral antibiotic therapy after valve surgery when indicated.
* Absence of fever, microbiological or analytical findings suggesting persistent infection at 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).
* Women of childbearing potential who will agree to the use of effective contraceptive methods while on antibiotic treatment.
Exclusion Criteria:
* Patients who have received appropriate parenteral antibiotic therapy for infective endocarditis for more than 12 days.
* Patients not suitable to be discharged after 10 days of conventional treatment, due to clinical reasons (sequels of stroke that prevent discharge, progressive renal failure, hepatic failure).
* Patients receiving chemotherapy or immunosuppressive therapy.
* Pregnant or breastfeeding women.
* Need of prolonged antibiotic therapy due to spondylodiscitis or other septic complication.
* 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 lack of language skills needed to complete the questionnaires.
* Patients who meet urgent cardiac surgery ESC criteria but are considered inoperable due to high surgical risk.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04222257
Study Brief:
Protocol Section:
NCT04222257