Oral antimicrobial treatment vs. outpatient parenteral for infective endocarditis
- Conditions
- Infective endocarditis
- Registration Number
- 2024-519969-21-00
- Lead Sponsor
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Brief Summary
To demonstrate the non-inferiority of outpatient oral antibiotic therapy in comparison with outpatient parenteral antibiotic treatment (OPAT)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 342
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.
Male or female 18 years old or older.
≥10 days of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after valve surgery
T<38.0° C for more than two days
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
No sign of abscess formation revealed by echocardiography
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.
Body mass index >40
Women in lactancy period
Concomitant infection requiring intravenous antibiotic therapy
Inability to give informed consent to participation
Suspicion of reduced absorption of oral treatment due to abdominal disorder
Microorganisms other than those defined in inclusion criteria
Any immunosuppressive disease or any medical condition at the discretion of the investigator that may preclude oral or OPAT therapy
No family or appropriate home support
Reduced compliance
Women of childbearing potential with a positive pregnancy test, or participants (male or female) who wish to plan a pregnancy during the trial period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method To evaluate quality of life and patient satisfaction To evaluate quality of life and patient satisfaction
To evaluate costs of both interventions through a pharmacoeconomic analysis. To evaluate costs of both interventions through a pharmacoeconomic analysis.
To evaluate number complications related to parenteral administration and oral administration of antibiotics (such as catheter related infections, Cl difficile diarrhea,among others). To evaluate number complications related to parenteral administration and oral administration of antibiotics (such as catheter related infections, Cl difficile diarrhea,among others).
Unplanned hospitalization, all-cause mortality, unplanned cardiac surgery and relapse of IE rates for each variable Unplanned hospitalization, all-cause mortality, unplanned cardiac surgery and relapse of IE rates for each variable
Trial Locations
- Locations (9)
Hospital General Alicante
🇪🇸Alicante, Spain
Hospital Universitario De Cruces
🇪🇸Barakaldo, Spain
University Hospital Virgen Del Rocio S.L.
🇪🇸Sevilla, Spain
Bellvitge University Hospital
🇪🇸L'Hospitalet De Llobregat, Spain
Consorci Sanitari De Terrassa
🇪🇸Terrassa, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Clinic De Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario De Canarias
🇪🇸San Cristobal De La Laguna, Spain
Hospital Universitario de Donostia
🇪🇸Gipuzkoa, Spain
Hospital General Alicante🇪🇸Alicante, SpainEsperanza MerinoSite contact+34966389146merino_luc@gva.es