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Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

RecruitingPhase 4Ages 18 Years - anyAllFundacion Clinic per a la Recerca Biomédica
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Cefaclor
  • Ciprofloxacin Tablets
  • Ciprofloxacin Injection
  • Clindamycin Oral Capsule
  • Clindamycin Injection
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Where

20 sites
Hospital General de Alicante
Alicante, Spain
Hospital Virgen de la Macarena
Seville, Spain
Hospital Virgen del Rocío
Seville, Spain
Hospital Son Espases
Palma de Mallorca, Spain
Hospital del Mar
Barcelona, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
Hospital Sant Pau
Barcelona, Spain
Hospital Bellvitge
Barcelona, Spain

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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