Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Summary

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

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

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-17

Primary Completion

2026-12-30

Completion

2027-12-30

Countries

• Spain

Study Locations