Oral antimicrobial treatment vs. outpatient parenteral for infectiveendocarditis. - OraPAT-IE GAMES

Phase 1

• Conditions: infective endocarditis; MedDRA version: 20.1Level: PTClassification code 10014666Term: Endocarditis bacterialSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-001024-34-ES
• Lead Sponsor: Fundació Clínic per a la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-13
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. 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.
2. Male or female 18 years old or older.
3. 10 days or more of appropriate parenteral antibiotic treatment overall and at
least one week of appropriate parenteral treatment after value surgery.
4. 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
6.Transthoracic / transesophageal echocardiography performed within 48 hours of randomization
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Body mass index >40
2. Concomitant infection requiring intravenous antibiotic therapy
3. Inability to give informed consent to participation
4. Suspicion of reduced absorption of oral treatment due to abdominal disorder
5. Microorganisms with no oral combinations for treatment (two active antibiotics of different families)
6. Any immunosuppressive disease or any medical condition at the discretion of the investigator that may preclude oral or OPAT therapy
7. No family or appropriate home support
8. Reduced compliance
9. Women of childbearing potential with a positive pregnancy test, or participants (male or female) who wish to plan a pregnancy during the trial period
10. Women in lactancy period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified