Comparing oral antibiotics to outpatient parenteral therapy for infective endocarditis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial is a non-inferiority study designed to evaluate whether a partial oral antibiotic treatment is as effective as outpatient parenteral antibiotic therapy (OPAT) for patients diagnosed with left-sided infective endocarditis. Participants will be randomized into two groups: one receiving oral antibiotics and the other receiving outpatient parenteral therapy after a minimum of 10 days of appropriate parenteral treatment. The goal is to demonstrate that oral therapy can maintain similar outcomes in terms of morbidity and mortality while potentially improving the quality of life and reducing costs for patients. The study will include patients who meet specific clinical criteria based on the modified Duke criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital General de Alicante
  Alicante, Alicante, Spain Recruiting
• Hospital Virgen de la Macarena
  Seville, Andalusia, Spain Recruiting
• Hospital Virgen del Rocío
  Seville, Andalusia, Spain Recruiting
• Hospital Son Espases
  Palma de Mallorca, Balearic Islands, Spain Recruiting
• Hospital del Mar
  Barcelona, Barcelona, Spain Recruiting
• Hospital Clinic i Provincial de Barcelona
  Barcelona, Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Anna Cruceta
• Email: acruceta@clinic.cat
• Phone: +34 932275400

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• San Matteo Endocarditis Registry (STEADY)

  This registry collects health and treatment information from people diagnosed with infective endocarditis at San Matteo to better understand their care and outcomes.

  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia, Lombardy · NCT07346222

• Continuous versus standard intermittent ampicillin plus ceftriaxone for Enterococcus faecalis endocarditis

  This study will see if giving ampicillin plus ceftriaxone as a continuous infusion works as well and is as safe as the usual intermittent dosing for adults with Enterococcus faecalis infective endocarditis.

  Recruiting at 4 sites Phase 4 Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Alava and 17 other locations · NCT06423898

• Prognosis of Infectious Endocarditis

  This study looks at how infectious endocarditis affects people with both natural and artificial heart valves to better understand the disease and improve treatment outcomes.

  Recruiting Centre Hospitalier Universitaire, Amiens · Amiens, Picardie · NCT03211975

• Al[18F]F-NOTA-folate PET imaging in suspected cardiac sarcoidosis and infective endocarditis

  This diagnostic test uses a folate-based PET tracer to see if it can help identify inflammation or infection in the heart for people with suspected cardiac sarcoidosis or infective endocarditis.

  Recruiting Turku University Hospital · Turku · NCT07814222

• Etiologic Diagnosis Algorithm in Infective Endocarditis

  Aiming to see if a combined culture and molecular testing approach can help doctors choose the right antibiotics faster for adults with infective endocarditis.

  Recruiting at 2 sites I.M. Sechenov First Moscow State Medical University · Moscow and 2 other locations · NCT07682389

• Rifampin-free therapy vs rifampin-containing therapy for staphylococcal prosthetic valve endocarditis

  This study tests whether a rifampin-free antibiotic regimen can be as effective as a rifampin-containing regimen for adults with staphylococcal prosthetic valve endocarditis.

  Recruiting at 29 sites Phase 3 Nantes University Hospital · Aix-les-Bains and 30 other locations · NCT07345325

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.