Short-course antibiotic regimen compared to conventional antibiotic treatment for gram-positive cocci infective endocarditis: randomized clinical trial

Phase 1

• Conditions: infective endocarditis; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-003358-10-ES
• Lead Sponsor: Carmen Olmos Blanco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-11
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 298

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified