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Oral antimicrobial treatment vs. outpatient parenteral for infective endocarditis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519969-21-00
Acronym
OraPAT-IE GAMES
Enrollment
342
Registered
2025-01-15
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infective endocarditis

Brief summary

Composite endpoint (whatever happen first) of unplanned hospitalization due to any reason, all-cause mortality, unplanned cardiac surgery and IE relapse within six months from diagnosis

Detailed description

To evaluate quality of life and patient satisfaction, To evaluate costs of both interventions through a pharmacoeconomic analysis., To evaluate number complications related to parenteral administration and oral administration of antibiotics (such as catheter related infections, Cl difficile diarrhea,among others)., Unplanned hospitalization, all-cause mortality, unplanned cardiac surgery and relapse of IE rates for each variable

Interventions

DRUGAMOXICILINA NORMON 1000 mg Comprimidos EFG

Sponsors

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Composite endpoint (whatever happen first) of unplanned hospitalization due to any reason, all-cause mortality, unplanned cardiac surgery and IE relapse within six months from diagnosis

Secondary

MeasureTime frame
To evaluate quality of life and patient satisfaction, To evaluate costs of both interventions through a pharmacoeconomic analysis., To evaluate number complications related to parenteral administration and oral administration of antibiotics (such as catheter related infections, Cl difficile diarrhea,among others)., Unplanned hospitalization, all-cause mortality, unplanned cardiac surgery and relapse of IE rates for each variable

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026