Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
Fundacion Clinic per a la Recerca Biomédica
360 participants
Aug 17, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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.
- 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 Criteria10
- 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
Interventions
cefaclor intravenous 2 gr/day
500-750 mg/12 hrs (maximum 3g x day)
1200 mg/day maximum dose IV
600 mg/8 hours (maximum 1.800 mg x day)
600 mg/8 hours (maximum 1.800 mg x day) IV
1g/8 hours (maximum 4 gr day)
1g/8 hours (maximum 4 g x day) IV
0,750g/12 hours (maximum 1,5 g x day)
0,75 g/12 hours (maximum 1,5 g x day)
0.5g/12-24hours (maximum 1 g x day)
0.5g/12-24hours (maximum 1 g x day)
0,6 g/12 hours (maximum 1200 mg x day)
0,6 g/12 hours (maximum 1200 mg x day)
0,4 g/day (maximum 400 mg x day)
0,4 g/day (maximum 400 mg x day)
0,3-0,5 g/12 hours (maximum 1200 mg x day)
0,3-0,6 g/12 hours (maximum 1200 mg x day)
sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
200 mg tedizolid (maximum x day)
200 mg (maximum x day)
1 gr/6 hours (4 g x day)
1 gr/6 hours (4 g x day) Intravenous
2 gr/day
Locations(20)
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NCT05398679