Clinical Trials in Spain / NCT05398679

Recruiting Phase 4

Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

NCT05398679 · tracked via the Priya Life Science Spain tracker

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Phase

Phase 4

Started

2022-08-17

Last updated

2026-07-07

Condition(s) studied

Endocarditis Infective

Investigational drug(s) / intervention(s)

Cefaclor →Ciprofloxacin Tablets →Ciprofloxacin Injection →Clindamycin Oral Capsule →Clindamycin Injection →Dicloxacillin Oral Capsule →Dicloxacillin →Fusidic Acid Only Product in Oral Dose FormFusidic Acid Only Product in Parenteral Dose FormLevofloxacin Oral Tablet →Levofloxacin Injection →Linezolid Oral Tablet →Linezolid Injectable ProductMoxifloxacin tablet →Moxifloxacin Injectable ProductRifampicin Only Product in Oral Dose FormRifampicin Only Product in Parenteral Dose FormSulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]Sulfamethoxazole / Trimethoprim Injectable ProductTedizolid Oral TabletTedizolid InjectionAmoxicillin Capsules →Amoxicillin →Cefaclor Capsules →

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

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of unplanned hospitalizations — At any time during the study duration (up to 24 months)
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of all-cause mortality — At any time during the study duration (up to 24 months)
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of relapses of Infective Endocarditis — within 6 months from diagnosis of Infective Endocarditis
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of patients requiring cardiac surgery — At any time during the study duration (up to 24 months)

Trial sites (20)

Facility	City	Region	Status
Hospital General de Alicante	Alicante	Alicante	Recruiting
Hospital Virgen de la Macarena	Seville	Andalusia	Recruiting
Hospital Virgen del Rocío	Seville	Andalusia	Recruiting
Hospital Son Espases	Palma de Mallorca	Balearic Islands	Recruiting
Hospital del Mar	Barcelona	Barcelona	Recruiting
Hospital Clinic i Provincial de Barcelona	Barcelona	Barcelona	Recruiting
Hospital Sant Pau	Barcelona	Barcelona	Recruiting
Hospital Bellvitge	Barcelona	Barcelona	Recruiting
Parc Taulí Hospital Universitari	Sabadell	Barcelona	Recruiting
Hospital Mútua de Terrassa	Terrassa	Barcelona	Recruiting
Hospital Universitario de Cruces	Barakaldo	Bizcaia	Recruiting
Hospital Universitario Marqués de Valdecilla	Santander	Cantabria	Recruiting
Hospital Universitario de Donostia	Donostia / San Sebastian	Guipuzcoa	Recruiting
Hospital San Pedro	Logroño	La Rioja	Recruiting
Hospital General Universitario Gregorio Marañón	Madrid	Madrid	Recruiting
Hospital Ramón y Cajal	Madrid	Madrid	Recruiting
Hospital Universitario La Paz	Madrid	Madrid	Recruiting
Hospital Virgen de Arrixaca	El Palmar	Murcia	Recruiting
Hospital universitario de Canarias	San Cristóbal de La Laguna	Santa Cruz de Tenerife	Recruiting
Hospital Universitari i Politècnic La Fe	Valencia	València	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05398679 on ClinicalTrials.gov ↗ ← All trials in Spain