Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Summary

Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis

Eligibility

Inclusion Criteria:

* 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 or more of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after value surgery.
* Temperature inferior to 38ºC for more than two days. 5. C-reactive protein dropped to \<25% of peak value or \<20 mg/l, and white blood cell count \<15x10\^9/l during antibiotic treatment
* Transthoracic / transesophageal echocardiography performed within 48 hours of randomization

Exclusion Criteria:

* Body mass index \>40
* 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 with no oral combinations for treatment (two active antibiotics of different families)
* 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
* Women in lactancy period

Conditions2

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