Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Last updated: March 10, 2025
Sponsor: Fundacion Clinic per a la Recerca Biomédica
Overall Status: Active - Recruiting

Phase

4

Condition

Heart Disease

Cardiovascular Disease

Cardiac Disease

Treatment

Levofloxacin Oral Tablet

Tedizolid Injection

Sulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]

Clinical Study ID

NCT05398679
OraPAT-IE GAMES
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Left-sided native or prosthetic infective endocarditis based on the modified Dukecriteria infected with one of the following nonresistant microorganisms:Non-resistant streptococci and other gram positive cocci,e.g., Granulicatella andAbiotrophia; Enterococcus faecalis; Staphylococcus aureus;coagulase-negativestaphylococci and HACEK group.

  • Male or female 18 years old or older.

  • 10 days or more of appropriate parenteral antibiotic treatment overall and at leastone week of appropriate parenteral treatment after value surgery.

  • Temperature inferior to 38ºC for more than two days. 5. C-reactive protein droppedto <25% of peak value or <20 mg/l, and white blood cell count <15x10^9/l duringantibiotic treatment

  • Transthoracic / transesophageal echocardiography performed within 48 hours ofrandomization

Exclusion

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 ofdifferent families)

  • Any immunosuppressive disease or any medical condition at the discretion of theinvestigator 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

Study Design

Total Participants: 360
Treatment Group(s): 24
Primary Treatment: Levofloxacin Oral Tablet
Phase: 4
Study Start date:
August 17, 2022
Estimated Completion Date:
December 30, 2027

Study Description

The trial will include patients diagnosed with left-side Infective Endocarditis according to the modified Duke criteria, with ≥10 days of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after valve surgery

The patients will be randomized in two arms, one with oral antibiotic therapy and the other one with outpatient parenteral therapy

This trial aims to demonstrate the non-inferiority of outpatient oral antibiotic therapy in comparison with outpatient parenteral antibiotic treatment (OPAT), to improve the quality of life of infective endocarditis (IE) patients, and to reduce the cost of the intervention without increasing morbidity and mortality rates

Connect with a study center

  • Hospital Virgen de la Macarena

    Sevilla, Andalucía 41009
    Spain

    Active - Recruiting

  • Hospital Virgen del Rocío

    Sevilla, Andalucía 41013
    Spain

    Active - Recruiting

  • Parc Taulí Hospital Universitari

    Sabadell, Barcelona 08208
    Spain

    Active - Recruiting

  • Hospital Mútua de Terrassa

    Terrassa, Barcelona 08221
    Spain

    Active - Recruiting

  • Hospital Universitario de Cruces

    Barakaldo, Bizcaia 48903
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Hospital Universitario de Donostia

    Donostia, Guipuzcoa 20014
    Spain

    Active - Recruiting

  • Hospital Son Espases

    Palma De Mallorca, Illes Balears 07120
    Spain

    Active - Recruiting

  • Hospital San Pedro

    Logroño, La Rioja 26006
    Spain

    Active - Recruiting

  • Hospital Virgen de Arrixaca

    El Palmar, Murcia 30120
    Spain

    Active - Recruiting

  • Hospital universitario de Canarias

    La Laguna, Santa Cruz De Tenerife 38320
    Spain

    Active - Recruiting

  • Hospital General de Alicante

    Alicante, 03010
    Spain

    Active - Recruiting

  • Hospital Bellvitge

    Barcelona, 08907
    Spain

    Active - Recruiting

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitari i Politècnic La Fe

    València, 46009
    Spain

    Site Not Available

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