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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05398679
Other study ID # OraPAT-IE GAMES
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date June 1, 2022
Est. completion date December 30, 2024

Study information

Verified date May 2022
Source Fundacion Clinic per a la Recerca Biomédica
Contact Anna Cruceta
Phone +34 932275400
Email acruceta@clinic.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


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Study Design


Intervention

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Locations

Country Name City State
Spain Hospital Clinic i Provincial de Barcelona Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

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)
See also
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