Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis — OraPAT-IEGAMES  

Endocarditis Infective Clinical Trial

Official title: Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial Description

The trial will include patients diagnosed with left-side Infective Endocarditis according to the modified Duke criteria, with ≥10 days of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after valve surgery

The patients will be randomized in two arms, one with oral antibiotic therapy and the other one with outpatient parenteral therapy

This trial aims to demonstrate the non-inferiority of outpatient oral antibiotic therapy in comparison with outpatient parenteral antibiotic treatment (OPAT), to improve the quality of life of infective endocarditis (IE) patients, and to reduce the cost of the intervention without increasing morbidity and mortality rates ;

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis Infective
• Endocarditis, Bacterial

• NCT number: NCT05398679
• Study type: Interventional
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: Anna Cruceta
• Phone: +34 932275400
• Email: acruceta@clinic.cat
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2022
• Completion date: December 30, 2024