Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

• Status: Not yet recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica
• Treatments: Amoxicillin; Cefaclor; Ciprofloxacin; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Dicloxacillin; Fusidic Acid; Levofloxacin; Linezolid; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ofloxacin; Oxazolidinones; Rifampin; Sulfamethoxazole; Tedizolid; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

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