AMOXICILLIN for Infective endocarditis | Bacterial endocarditis

Inclusion criteria

• {"criterion_text":"- Left-sided native or prosthetic infective endocarditis based on the modified Duke criteria infected with one of the following nonresistant microorganisms: Non-resistant streptococci and other gram positive cocci,e.g., Granulicatella and Abiotrophia; Enterococcus faecalis; Staphylococcus aureus;coagulase-negative staphylococci and HACEK group.\n- Male or female 18 years old or older.\n- ≥10 days of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after valve surgery\n- T<38.0° C for more than two days\n- C-reactive protein dropped below 25% of the peak value or below an absolute value of 20 mg/L, and the white blood cell count dropped to less than 15 × 10(9)/L during antibiotic treatment\n- No sign of abscess formation revealed by echocardiography\n- Transthoracic/transesophageal echocardiography performed preferably within 48 h of randomization. Ecoscopy or portable echocardiogram are also admitted, as long as they are registered on the clinical history."}

Exclusion criteria

• {"criterion_text":"- Body mass index >40\n- Concomitant infection requiring intravenous antibiotic therapy\n- Inability to give informed consent to participation\n- Suspicion of reduced absorption of oral treatment due to abdominal disorder\n- Microorganisms other than those defined in inclusion criteria\n- Any immunosuppressive disease or any medical condition at the discretion of the investigator that may preclude oral or OPAT therapy\n- No family or appropriate home support\n- Reduced compliance\n- Women of childbearing potential with a positive pregnancy test, or participants (male or female) who wish to plan a pregnancy during the trial period.\n- Women in lactancy period"}

Primary endpoints

• {"endpoint_text":"- Composite endpoint (whatever happen first) of unplanned hospitalization due to any reason, all-cause mortality, unplanned cardiac surgery and IE relapse within six months from diagnosis","definition_or_measurement_approach":"Composite of unplanned hospitalization (any cause), all-cause mortality, unplanned cardiac surgery and infective endocarditis relapse assessed within six months from diagnosis (time-to-first event composite measured over 6 months)."}

Secondary endpoints

• {"endpoint_text":"- To evaluate quality of life and patient satisfaction","definition_or_measurement_approach":"Assessment of quality of life and patient satisfaction as stated in protocol; specific instruments or timing not provided in CTIS metadata."}
• {"endpoint_text":"- To evaluate costs of both interventions through a pharmacoeconomic analysis.","definition_or_measurement_approach":"Pharmacoeconomic analysis to evaluate costs of oral vs parenteral interventions; detailed methodology not specified in CTIS metadata."}
• {"endpoint_text":"- To evaluate number complications related to parenteral administration and oral administration of antibiotics (such as catheter related infections, Cl difficile diarrhea,among others).","definition_or_measurement_approach":"Counting and comparison of complications related to parenteral and oral antibiotic administration (e.g., catheter-related infections, Clostridioides difficile diarrhea); specific definitions not provided in CTIS metadata."}
• {"endpoint_text":"- Unplanned hospitalization, all-cause mortality, unplanned cardiac surgery and relapse of IE rates for each variable","definition_or_measurement_approach":"Rates of each component (unplanned hospitalization, all-cause mortality, unplanned cardiac surgery, IE relapse) measured separately; timing not further specified beyond primary 6-month window."}

Spain

Earliest CTIS Part Ii Submission Date

20-12-2024

Latest Decision Or Authorization Date

16-12-2025

Processing Time Days

361

Number Of Sites

12

Number Of Participants

342

Primary sponsor

Full Name

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain