Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacion Clinic per a la Recerca Biomédica

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

360 Participants
are divided into 2 treatment groups