Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis
The trial will include patients diagnosed with left-side Infective Endocarditis according to the modified Duke criteria, with ≥10 days of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after valve surgery The patients will be randomized in two arms, one with oral antibiotic therapy and the other one with outpatient parenteral therapy This trial aims to demonstrate the non-inferiority of outpatient oral antibiotic therapy in comparison with outpatient parenteral antibiotic treatment (OPAT), to improve the quality of life of infective endocarditis (IE) patients, and to reduce the cost of the intervention without increasing morbidity and mortality rates
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
cefaclor intravenous 2 gr/day
500-750 mg/12 hrs (maximum 3g x day)
1200 mg/day maximum dose IV
Hospital Virgen de la Macarena
Seville, Andalusia, Spain
RECRUITINGNon-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of unplanned hospitalizations
Time frame: At any time during the study duration (up to 24 months)
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of all-cause mortality
Time frame: At any time during the study duration (up to 24 months)
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of relapses of Infective Endocarditis
Time frame: within 6 months from diagnosis of Infective Endocarditis
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of patients requiring cardiac surgery
Time frame: At any time during the study duration (up to 24 months)
Quality of life and patient satisfaction of infective endocarditis patients. It will be measured through the standardized Saillen questionnaire of antibiotic treatment satisfaction
Time frame: At any time during the study duration (up to 24 months)
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
Time frame: At any time during the study duration (up to 24 months)
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
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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
Hospital Virgen del Rocío
Seville, Andalusia, Spain
RECRUITINGHospital Son Espases
Palma de Mallorca, Balearic Islands, Spain
RECRUITINGParc Taulí Hospital Universitari
Sabadell, Barcelona, Spain
RECRUITINGHospital Mútua de Terrassa
Terrassa, Barcelona, Spain
RECRUITINGHospital Universitario de Cruces
Barakaldo, Bizcaia, Spain
RECRUITINGHospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
RECRUITINGHospital Universitario de Donostia
Donostia / San Sebastian, Guipuzcoa, Spain
RECRUITINGHospital San Pedro
Logroño, La Rioja, Spain
RECRUITINGHospital Virgen de Arrixaca
El Palmar, Murcia, Spain
RECRUITING...and 10 more locations
Time frame: At any time during the study duration (up to 24 months)