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Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
Sponsor: Fundacion Clinic per a la Recerca Biomédica
Summary
Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2022-08-17
Completion Date
2027-12-30
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
Cefaclor
cefaclor intravenous 2 gr/day
Ciprofloxacin Tablets
500-750 mg/12 hrs (maximum 3g x day)
Ciprofloxacin Injection
1200 mg/day maximum dose IV
Clindamycin Oral Capsule
600 mg/8 hours (maximum 1.800 mg x day)
Clindamycin Injection
600 mg/8 hours (maximum 1.800 mg x day) IV
Dicloxacillin Oral Capsule
1g/8 hours (maximum 4 gr day)
Dicloxacillin
1g/8 hours (maximum 4 g x day) IV
Fusidic Acid Only Product in Oral Dose Form
0,750g/12 hours (maximum 1,5 g x day)
Fusidic Acid Only Product in Parenteral Dose Form
0,75 g/12 hours (maximum 1,5 g x day)
Levofloxacin Oral Tablet
0.5g/12-24hours (maximum 1 g x day)
Levofloxacin Injection
0.5g/12-24hours (maximum 1 g x day)
Linezolid Oral Tablet
0,6 g/12 hours (maximum 1200 mg x day)
Linezolid Injectable Product
0,6 g/12 hours (maximum 1200 mg x day)
Moxifloxacin tablet
0,4 g/day (maximum 400 mg x day)
Moxifloxacin Injectable Product
0,4 g/day (maximum 400 mg x day)
Rifampicin Only Product in Oral Dose Form
0,3-0,5 g/12 hours (maximum 1200 mg x day)
Rifampicin Only Product in Parenteral Dose Form
0,3-0,6 g/12 hours (maximum 1200 mg x day)
Sulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]
sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
Sulfamethoxazole / Trimethoprim Injectable Product
sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
Tedizolid Oral Tablet
200 mg tedizolid (maximum x day)
Tedizolid Injection
200 mg (maximum x day)
Amoxicillin Capsules
1 gr/6 hours (4 g x day)
Amoxicillin
1 gr/6 hours (4 g x day) Intravenous
Cefaclor Capsules
2 gr/day
Locations (20)
Hospital General de Alicante
Alicante, Alicante, Spain
Hospital Virgen de la Macarena
Seville, Andalusia, Spain
Hospital Virgen del Rocío
Seville, Andalusia, Spain
Hospital Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Barcelona, Spain
Hospital Sant Pau
Barcelona, Barcelona, Spain
Hospital Bellvitge
Barcelona, Barcelona, Spain
Parc Taulí Hospital Universitari
Sabadell, Barcelona, Spain
Hospital Mútua de Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario de Cruces
Barakaldo, Bizcaia, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, Guipuzcoa, Spain
Hospital San Pedro
Logroño, La Rioja, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Madrid, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital Virgen de Arrixaca
El Palmar, Murcia, Spain
Hospital universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain
Hospital Universitari i Politècnic La Fe
Valencia, València, Spain