Endocarditis Infective Clinical Trial
— OraPAT-IEGAMESOfficial title:
Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis
Status | Not yet recruiting |
Enrollment | 360 |
Est. completion date | December 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinic i Provincial de Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundacion Clinic per a la Recerca Biomédica |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of unplanned hospitalizations | At any time during the study duration (up to 24 months) | ||
Primary | Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of all-cause mortality | At any time during the study duration (up to 24 months) | ||
Primary | Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of relapses of Infective Endocarditis | within 6 months from diagnosis of Infective Endocarditis | ||
Primary | Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of patients requiring cardiac surgery | At any time during the study duration (up to 24 months) | ||
Secondary | Quality of life and patient satisfaction of infective endocarditis patients. It will be measured through the standardized Saillen questionnaire of antibiotic treatment satisfaction | At any time during the study duration (up to 24 months) | ||
Secondary | Costs of both interventions, measured through a pharmaco-economic sub-study including direct and indirect costs, following the methodology described by Lacroix A et al Med Mal Infect. 2014 | through a pharmacoeconomic analysis | At any time during the study duration (up to 24 months) | |
Secondary | The complications related to parenteral and oral administration of antibiotics will be measured through the number of antibiotic adverse reactions, catheter-related adverse events, and number of superinfections | such as antibiotic or catheter-related adverse events e.g.,phlebitis and line-related bloodstream infections, and superinfections | At any time during the study duration (up to 24 months) |
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