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RECRUITING
NCT05398679
PHASE4

Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Sponsor: Fundacion Clinic per a la Recerca Biomédica

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2022-08-17

Completion Date

2027-12-30

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

DRUG

Cefaclor

cefaclor intravenous 2 gr/day

DRUG

Ciprofloxacin Tablets

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

DRUG

Ciprofloxacin Injection

1200 mg/day maximum dose IV

DRUG

Clindamycin Oral Capsule

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

DRUG

Clindamycin Injection

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

DRUG

Dicloxacillin Oral Capsule

1g/8 hours (maximum 4 gr day)

DRUG

Dicloxacillin

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

DRUG

Fusidic Acid Only Product in Oral Dose Form

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

DRUG

Fusidic Acid Only Product in Parenteral Dose Form

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

DRUG

Levofloxacin Oral Tablet

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

DRUG

Levofloxacin Injection

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

DRUG

Linezolid Oral Tablet

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

DRUG

Linezolid Injectable Product

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

DRUG

Moxifloxacin tablet

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

DRUG

Moxifloxacin Injectable Product

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

DRUG

Rifampicin Only Product in Oral Dose Form

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

DRUG

Rifampicin Only Product in Parenteral Dose Form

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

DRUG

Sulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]

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

DRUG

Sulfamethoxazole / Trimethoprim Injectable Product

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

DRUG

Tedizolid Oral Tablet

200 mg tedizolid (maximum x day)

DRUG

Tedizolid Injection

200 mg (maximum x day)

DRUG

Amoxicillin Capsules

1 gr/6 hours (4 g x day)

DRUG

Amoxicillin

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

DRUG

Cefaclor 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