Actively Recruiting
Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
Led by Fundacion Clinic per a la Recerca Biomédica · Updated on 2026-02-25
360
Participants Needed
20
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis
CONDITIONS
Official Title
Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 valve surgery.
- Temperature below 38ºC for more than two days.
- C-reactive protein dropped to less than 25% of peak value or less than 20 mg/l, and white blood cell count less than 15x10^9/l during antibiotic treatment.
- Transthoracic or transesophageal echocardiography performed within 48 hours of randomization.
You will not qualify if you...
- Body mass index over 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 outpatient parenteral 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 20 locations
1
Hospital General de Alicante
Alicante, Alicante, Spain, 03010
Actively Recruiting
2
Hospital Virgen de la Macarena
Seville, Andalusia, Spain, 41009
Actively Recruiting
3
Hospital Virgen del Rocío
Seville, Andalusia, Spain, 41013
Actively Recruiting
4
Hospital Son Espases
Palma de Mallorca, Balearic Islands, Spain, 07120
Actively Recruiting
5
Hospital del Mar
Barcelona, Barcelona, Spain, 08003
Actively Recruiting
6
Hospital Clinic i Provincial de Barcelona
Barcelona, Barcelona, Spain, 08036
Actively Recruiting
7
Hospital Sant Pau
Barcelona, Barcelona, Spain, 08041
Actively Recruiting
8
Hospital Bellvitge
Barcelona, Barcelona, Spain, 08907
Actively Recruiting
9
Parc Taulí Hospital Universitari
Sabadell, Barcelona, Spain, 08208
Actively Recruiting
10
Hospital Mútua de Terrassa
Terrassa, Barcelona, Spain, 08221
Actively Recruiting
11
Hospital Universitario de Cruces
Barakaldo, Bizcaia, Spain, 48903
Actively Recruiting
12
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
13
Hospital Universitario de Donostia
Donostia / San Sebastian, Guipuzcoa, Spain, 20014
Actively Recruiting
14
Hospital San Pedro
Logroño, La Rioja, Spain, 26006
Actively Recruiting
15
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain, 28007
Actively Recruiting
16
Hospital Ramón y Cajal
Madrid, Madrid, Spain, 28034
Actively Recruiting
17
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
18
Hospital Virgen de Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
19
Hospital universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain, 38320
Actively Recruiting
20
Hospital Universitari i Politècnic La Fe
Valencia, València, Spain, 46009
Not Yet Recruiting
Research Team
A
Anna Cruceta
CONTACT
L
Laura Burunat
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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