Status:
RECRUITING
Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
Lead Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Conditions:
Endocarditis Infective
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis
Detailed 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 lea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT05398679
Start Date
August 17 2022
End Date
December 30 2027
Last Update
March 11 2025
Active Locations (20)
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1
Hospital Virgen de la Macarena
Seville, Andalusia, Spain, 41009
2
Hospital Virgen del Rocío
Seville, Andalusia, Spain, 41013
3
Hospital Son Espases
Palma de Mallorca, Balearic Islands, Spain, 07120
4
Parc Taulí Hospital Universitari
Sabadell, Barcelona, Spain, 08208