Clinical trial NCT05398679: Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
Official title: Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Endocarditis Infective
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: National multi-center study, open, controlled, and randomized
Primary purpose: TREATMENT

Brief summary: Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis

Detailed 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

Eligibility criteria: Inclusion Criteria:

* 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

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 of different families)
* Any immunosuppressive disease or any medical condition at the discretion of the investigator 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

Primary outcomes:
measure: Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of unplanned hospitalizations
timeFrame: At any time during the study duration (up to 24 months)
measure: Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of all-cause mortality
timeFrame: At any time during the study duration (up to 24 months)
measure: Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of relapses of Infective Endocarditis
timeFrame: within 6 months from diagnosis of Infective Endocarditis
measure: Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of patients requiring cardiac surgery
timeFrame: At any time during the study duration (up to 24 months)
Secondary outcomes:
measure: Quality of life and patient satisfaction of infective endocarditis patients. It will be measured through the standardized Saillen questionnaire of antibiotic treatment satisfaction
timeFrame: At any time during the study duration (up to 24 months)
measure: Costs of both interventions, measured through a pharmaco-economic sub-study including direct and indirect costs, following the methodology described by Lacroix A et al Med Mal Infect. 2014
timeFrame: At any time during the study duration (up to 24 months)
measure: The complications related to parenteral and oral administration of antibiotics will be measured through the number of antibiotic adverse reactions, catheter-related adverse events, and number of superinfections
timeFrame: At any time during the study duration (up to 24 months)
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Virgen de la Macarena
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
state: Andalucía
city: Sabadell
country: Spain
facility: Parc Taulí Hospital Universitari
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mútua de Terrassa
state: Barcelona
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
state: Bizcaia
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Donostia
country: Spain
facility: Hospital Universitario de Donostia
state: Guipuzcoa
city: Palma De Mallorca
country: Spain
facility: Hospital Son Espases
state: Illes Balears
city: Logroño
country: Spain
facility: Hospital San Pedro
state: La Rioja
city: El Palmar
country: Spain
facility: Hospital Virgen de Arrixaca
state: Murcia
city: La Laguna
country: Spain
facility: Hospital universitario de Canarias
state: Santa Cruz De Tenerife
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Barcelona
country: Spain
facility: Hospital Bellvitge
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: València
country: Spain
facility: Hospital Universitari i Politècnic La Fe
Study officials:
References: