Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05398679

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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