Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Spain
Hospital General de Alicante
RECRUITING
Alicante
Hospital Universitario de Cruces
RECRUITING
Barakaldo
Hospital Bellvitge
RECRUITING
Barcelona
Hospital Clinic i Provincial de Barcelona
RECRUITING
Barcelona
Hospital del Mar
RECRUITING
Barcelona
Hospital Sant Pau
RECRUITING
Barcelona
Hospital Universitario de Donostia
RECRUITING
Donostia / San Sebastian
Hospital Virgen de Arrixaca
RECRUITING
El Palmar
Hospital San Pedro
RECRUITING
Logroño
Hospital General Universitario Gregorio Marañón
RECRUITING
Madrid
Hospital Ramón y Cajal
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Son Espases
RECRUITING
Palma De Mallorca
Parc Taulí Hospital Universitari
RECRUITING
Sabadell
Hospital universitario de Canarias
RECRUITING
San Cristóbal De La Laguna
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Virgen de la Macarena
RECRUITING
Seville
Hospital Virgen del Rocío
RECRUITING
Seville
Hospital Mútua de Terrassa
RECRUITING
Terrassa
Hospital Universitari i Politècnic La Fe
NOT_YET_RECRUITING
Valencia
Contact Information
Primary
Anna Cruceta
acruceta@clinic.cat
+34 932275400
Backup
Laura Burunat
burunat@clinic.cat
+34 932275400
Time Frame
Start Date:2022-08-17
Estimated Completion Date:2027-12-30
Participants
Target number of participants:360
Treatments
Active_comparator: OPAT
Patients with infective endocarditis diagnostic, who have completed at least 10 days of intravenous therapy, and/ or seven days in the case of cardiac valvular surgery, and shown good clinical evolution and no clinical or echocardiographic signs of potential bad prognosis will be randomized. If assigned to this arm the patient will recieve parenteral antibiotics until the end of treatment.
Experimental: Oral Therapy
Patients with infective endocarditis diagnostic, who have completed at least 10 days of intravenous therapy, and/ or seven days in the case of cardiac valvular surgery, and shown good clinical evolution and no clinical or echocardiographic signs of potential bad prognosis will be randomized. If assigned to this arm the patient will recieve oral antibiotics until the end of treatment.