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

F

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)

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]

Trial contacts and locations

20

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Central trial contact

Anna Cruceta; Laura Burunat

Data sourced from clinicaltrials.gov

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