RecruitingPhase 4NCT05398679

Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Enrollment

360 participants

Start Date

Aug 17, 2022

Study Type

INTERVENTIONAL

Conditions

Endocarditis Infective

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing oral (by mouth) antibiotics versus intravenous (IV) antibiotics given at home or in an outpatient setting for treating infective endocarditis — a serious infection of the heart's inner lining or valves. **You may be eligible if...** - You have been diagnosed with infective endocarditis of the left-sided heart valves (native or prosthetic) - Your infection is caused by specific treatable bacteria, including streptococci, Enterococcus faecalis, or non-resistant Staphylococcus aureus - You have been initially stabilized on IV antibiotics - You do not have complications requiring ongoing hospitalization **You may NOT be eligible if...** - Your infection is caused by highly resistant bacteria - You have serious complications such as heart failure, abscess, or stroke - You have significant problems absorbing oral medications - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCefaclor

cefaclor intravenous 2 gr/day

DRUGCiprofloxacin Tablets

500-750 mg/12 hrs (maximum 3g x day)

DRUGCiprofloxacin Injection

1200 mg/day maximum dose IV

DRUGClindamycin Oral Capsule

600 mg/8 hours (maximum 1.800 mg x day)

DRUGClindamycin Injection

600 mg/8 hours (maximum 1.800 mg x day) IV

DRUGDicloxacillin Oral Capsule

1g/8 hours (maximum 4 gr day)

DRUGDicloxacillin

1g/8 hours (maximum 4 g x day) IV

DRUGFusidic Acid Only Product in Oral Dose Form

0,750g/12 hours (maximum 1,5 g x day)

DRUGFusidic Acid Only Product in Parenteral Dose Form

0,75 g/12 hours (maximum 1,5 g x day)

DRUGLevofloxacin Oral Tablet

0.5g/12-24hours (maximum 1 g x day)

DRUGLevofloxacin Injection

0.5g/12-24hours (maximum 1 g x day)

DRUGLinezolid Oral Tablet

0,6 g/12 hours (maximum 1200 mg x day)

DRUGLinezolid Injectable Product

0,6 g/12 hours (maximum 1200 mg x day)

DRUGMoxifloxacin tablet

0,4 g/day (maximum 400 mg x day)

DRUGMoxifloxacin Injectable Product

0,4 g/day (maximum 400 mg x day)

DRUGRifampicin Only Product in Oral Dose Form

0,3-0,5 g/12 hours (maximum 1200 mg x day)

DRUGRifampicin Only Product in Parenteral Dose Form

0,3-0,6 g/12 hours (maximum 1200 mg x day)

DRUGSulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]

sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)

DRUGSulfamethoxazole / Trimethoprim Injectable Product

sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)

DRUGTedizolid Oral Tablet

200 mg tedizolid (maximum x day)

DRUGTedizolid Injection

200 mg (maximum x day)

DRUGAmoxicillin Capsules

1 gr/6 hours (4 g x day)

DRUGAmoxicillin

1 gr/6 hours (4 g x day) Intravenous

DRUGCefaclor Capsules

2 gr/day

Locations(20)

Hospital General de Alicante

Alicante, Alicante, Spain

Hospital Virgen de la Macarena

Seville, Andalusia, Spain

Hospital Virgen del Rocío

Seville, Andalusia, Spain

Hospital Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital del Mar

Barcelona, Barcelona, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Barcelona, Spain

Hospital Sant Pau

Barcelona, Barcelona, Spain

Hospital Bellvitge

Barcelona, Barcelona, Spain

Parc Taulí Hospital Universitari

Sabadell, Barcelona, Spain

Hospital Mútua de Terrassa

Terrassa, Barcelona, Spain

Hospital Universitario de Cruces

Barakaldo, Bizcaia, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario de Donostia

Donostia / San Sebastian, Guipuzcoa, Spain

Hospital San Pedro

Logroño, La Rioja, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Hospital Ramón y Cajal

Madrid, Madrid, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital Virgen de Arrixaca

El Palmar, Murcia, Spain

Hospital universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain

Hospital Universitari i Politècnic La Fe

Valencia, València, Spain

View Full Details on ClinicalTrials.gov

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NCT05398679

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