Comparing oral antibiotics to outpatient parenteral therapy for infective endocarditis
Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
PHASE4 · Fundacion Clinic per a la Recerca Biomédica · NCT05398679
This study is testing if taking oral antibiotics at home is just as effective as getting antibiotics through an IV for patients with left-sided infective endocarditis.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundacion Clinic per a la Recerca Biomédica (other) |
| Locations | 20 sites (Alicante, Alicante and 19 other locations) |
| Trial ID | NCT05398679 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with left-sided infective endocarditis who have received appropriate parenteral antibiotic treatment.
Not a fit: Patients with a body mass index over 40 or those requiring intravenous antibiotic therapy for concomitant infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more convenient and cost-effective treatment option for patients with infective endocarditis.
How similar studies have performed: Other studies have explored outpatient parenteral therapy, but this specific comparison of oral antibiotics for infective endocarditis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Alicante, Alicante and 19 other locations
- 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)
- Hospital Sant Pau — Barcelona, Barcelona, Spain (RECRUITING)
- Hospital Bellvitge — Barcelona, Barcelona, Spain (RECRUITING)
- Parc Taulí Hospital Universitari — Sabadell, Barcelona, Spain (RECRUITING)
- Hospital Mútua de Terrassa — Terrassa, Barcelona, Spain (RECRUITING)
- Hospital Universitario de Cruces — Barakaldo, Bizcaia, Spain (RECRUITING)
- Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain (RECRUITING)
- Hospital Universitario de Donostia — Donostia / San Sebastian, Guipuzcoa, Spain (RECRUITING)
- Hospital San Pedro — Logroño, La Rioja, Spain (RECRUITING)
- Hospital General Universitario Gregorio Marañón — Madrid, Madrid, Spain (RECRUITING)
- Hospital Ramón y Cajal — Madrid, Madrid, Spain (RECRUITING)
- Hospital Universitario La Paz — Madrid, Madrid, Spain (RECRUITING)
- Hospital Virgen de Arrixaca — El Palmar, Murcia, Spain (RECRUITING)
- Hospital universitario de Canarias — San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain (RECRUITING)
- Hospital Universitari i Politècnic La Fe — Valencia, València, Spain (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Anna Cruceta
- Email: acruceta@clinic.cat
- Phone: +34 932275400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endocarditis Infective