|
Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
RECRUITINGPhase 4Sponsored by Fundacion Clinic per a la Recerca Biomédica
Actively Recruiting
PhasePhase 4
SponsorFundacion Clinic per a la Recerca Biomédica
Started2022-08-17
Est. completion2026-12-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05398679
Summary
Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis
Eligibility
Age: 18 Years+Healthy volunteers accepted
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
Conditions2
Endocarditis InfectiveHeart Disease
Interventions24
AmoxicillinAmoxicillin CapsulesCefaclorCefaclor CapsulesCiprofloxacin InjectionCiprofloxacin TabletsClindamycin InjectionClindamycin Oral CapsuleDicloxacillinDicloxacillin Oral CapsuleFusidic Acid Only Product in Oral Dose FormFusidic Acid Only Product in Parenteral Dose FormLevofloxacin InjectionLevofloxacin Oral TabletLinezolid Injectable ProductLinezolid Oral TabletMoxifloxacin Injectable ProductMoxifloxacin tabletRifampicin Only Product in Oral Dose FormRifampicin Only Product in Parenteral Dose FormSulfamethoxazole / Trimethoprim Injectable ProductSulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]Tedizolid InjectionTedizolid Oral Tablet
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
Actively Recruiting
PhasePhase 4
SponsorFundacion Clinic per a la Recerca Biomédica
Started2022-08-17
Est. completion2026-12-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05398679