Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis (OraPAT-IEGAMES)

Fundacion Clinic per a la Recerca Biomédica

Status and phase: Enrolling; Phase 4

Conditions: Endocarditis Infective

Treatments: Drug: Amoxicillin Capsules; Drug: Linezolid Injectable Product; Drug: Moxifloxacin tablet; Drug: Ciprofloxacin Tablets; Drug: Fusidic Acid Only Product in Oral Dose Form; Drug: Rifampicin Only Product in Parenteral Dose Form; Drug: Linezolid Oral Tablet; Drug: Clindamycin Injection; Drug: Amoxicillin; Drug: Levofloxacin Oral Tablet; Drug: Cefaclor Capsules; Drug: Ciprofloxacin Injection; Drug: Sulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]; Drug: Tedizolid Injection; Drug: Clindamycin Oral Capsule; Drug: Tedizolid Oral Tablet; Drug: Dicloxacillin; Drug: Cefaclor; Drug: Sulfamethoxazole / Trimethoprim Injectable Product; Drug: Levofloxacin Injection; Drug: Fusidic Acid Only Product in Parenteral Dose Form; Drug: Rifampicin Only Product in Oral Dose Form; Drug: Dicloxacillin Oral Capsule; Drug: Moxifloxacin Injectable Product

Study type: Interventional

Funder types: Other

Identifiers

NCT05398679

OraPAT-IE GAMES

Details and patient eligibility

About

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

Full description

The trial will include patients diagnosed with left-side Infective Endocarditis according to the modified Duke criteria, with ≥10 days of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after valve surgery

The patients will be randomized in two arms, one with oral antibiotic therapy and the other one with outpatient parenteral therapy

This trial aims to demonstrate the non-inferiority of outpatient oral antibiotic therapy in comparison with outpatient parenteral antibiotic treatment (OPAT), to improve the quality of life of infective endocarditis (IE) patients, and to reduce the cost of the intervention without increasing morbidity and mortality rates

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

OPAT

Active Comparator group

Description:

Patients with infective endocarditis diagnostic, who have completed at least 10 days of intravenous therapy, and/ or seven days in the case of cardiac valvular surgery, and shown good clinical evolution and no clinical or echocardiographic signs of potential bad prognosis will be randomized. If assigned to this arm the patient will recieve parenteral antibiotics until the end of treatment.

Treatment:

Drug: Moxifloxacin Injectable Product

Drug: Ciprofloxacin Injection

Drug: Amoxicillin

Drug: Clindamycin Injection

Drug: Fusidic Acid Only Product in Parenteral Dose Form

Drug: Rifampicin Only Product in Parenteral Dose Form

Drug: Levofloxacin Injection

Drug: Sulfamethoxazole / Trimethoprim Injectable Product

Drug: Linezolid Injectable Product

Drug: Cefaclor

Drug: Dicloxacillin

Drug: Tedizolid Injection

Oral Therapy

Experimental group

Description:

Patients with infective endocarditis diagnostic, who have completed at least 10 days of intravenous therapy, and/ or seven days in the case of cardiac valvular surgery, and shown good clinical evolution and no clinical or echocardiographic signs of potential bad prognosis will be randomized. If assigned to this arm the patient will recieve oral antibiotics until the end of treatment.

Treatment:

Drug: Dicloxacillin Oral Capsule

Drug: Cefaclor Capsules

Drug: Rifampicin Only Product in Oral Dose Form

Drug: Levofloxacin Oral Tablet

Drug: Linezolid Oral Tablet

Drug: Fusidic Acid Only Product in Oral Dose Form

Drug: Moxifloxacin tablet

Drug: Ciprofloxacin Tablets

Drug: Tedizolid Oral Tablet

Drug: Amoxicillin Capsules

Drug: Clindamycin Oral Capsule

Drug: Sulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]