Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Recruiting now · Phase 4

Conditions studied: Endocarditis Infective

In brief

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

Key facts

Study ID

NCT05398679

Run by

Fundacion Clinic per a la Recerca Biomédica

People needed

360

Starts

2022-08-17

Expected to finish

2027-12-30

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hospital General de Alicante — Alicante, Alicante, Spain (enrolling)
• Hospital Virgen de la Macarena — Seville, Andalusia, Spain (enrolling)
• Hospital Virgen del Rocío — Seville, Andalusia, Spain (enrolling)
• Hospital Son Espases — Palma de Mallorca, Balearic Islands, Spain (enrolling)
• Hospital del Mar — Barcelona, Barcelona, Spain (enrolling)
• Hospital Clinic i Provincial de Barcelona — Barcelona, Barcelona, Spain (enrolling)
• Hospital Sant Pau — Barcelona, Barcelona, Spain (enrolling)
• Hospital Bellvitge — Barcelona, Barcelona, Spain (enrolling)
• Parc Taulí Hospital Universitari — Sabadell, Barcelona, Spain (enrolling)
• Hospital Mútua de Terrassa — Terrassa, Barcelona, Spain (enrolling)
• Hospital Universitario de Cruces — Barakaldo, Bizcaia, Spain (enrolling)
• Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain (enrolling)
• Hospital Universitario de Donostia — Donostia / San Sebastian, Guipuzcoa, Spain (enrolling)
• Hospital San Pedro — Logroño, La Rioja, Spain (enrolling)
• Hospital General Universitario Gregorio Marañón — Madrid, Madrid, Spain (enrolling)
• Hospital Ramón y Cajal — Madrid, Madrid, Spain (enrolling)
• Hospital Universitario La Paz — Madrid, Madrid, Spain (enrolling)
• Hospital Virgen de Arrixaca — El Palmar, Murcia, Spain (enrolling)
• Hospital universitario de Canarias — San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain (enrolling)
• Hospital Universitari i Politècnic La Fe — Valencia, València, Spain

Full record on ClinicalTrials.gov

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