Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

PHASE4RecruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

August 17, 2022

Primary Completion Date

October 30, 2026

Study Completion Date

December 30, 2027

Conditions
Endocarditis Infective
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

Trial Locations (20)

20014

RECRUITING

Hospital Universitario de Donostia, Donostia / San Sebastian

26006

RECRUITING

Hospital San Pedro, Logroño

28007

RECRUITING

Hospital General Universitario Gregorio Marañón, Madrid

28034

RECRUITING

Hospital Ramón y Cajal, Madrid

28046

RECRUITING

Hospital Universitario La Paz, Madrid

30120

RECRUITING

Hospital Virgen de Arrixaca, El Palmar

38320

RECRUITING

Hospital universitario de Canarias, San Cristóbal de La Laguna

39008

RECRUITING

Hospital Universitario Marqués de Valdecilla, Santander

41009

RECRUITING

Hospital Virgen de la Macarena, Seville

41013

RECRUITING

Hospital Virgen del Rocío, Seville

46009

NOT_YET_RECRUITING

Hospital Universitari i Politècnic La Fe, Valencia

48903

RECRUITING

Hospital Universitario de Cruces, Barakaldo

07120

RECRUITING

Hospital Son Espases, Palma de Mallorca

08208

RECRUITING

Parc Taulí Hospital Universitari, Sabadell

08221

RECRUITING

Hospital Mútua de Terrassa, Terrassa

03010

RECRUITING

Hospital General de Alicante, Alicante

08003

RECRUITING

Hospital del Mar, Barcelona

08036

RECRUITING

Hospital Clinic i Provincial de Barcelona, Barcelona

08041

RECRUITING

Hospital Sant Pau, Barcelona

08907

RECRUITING

Hospital Bellvitge, Barcelona

All Listed Sponsors
lead

Fundacion Clinic per a la Recerca Biomédica

OTHER