Oral antimicrobial treatment vs. outpatient parenteral for infective endocarditis. - OraPAT-IE GAMES

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001024-34-ES

Enrollment

360

Registered

2021-09-13

Start date

2021-12-15

Completion date

Unknown

Last updated

2021-12-21

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

Conditions

infective endocarditis MedDRA version: 20.1 Level: PT Classification code 10014666 Term: Endocarditis bacterial System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: amoxicillin Pharmaceutical Form: Tablet INN or Proposed INN: Amoxicillin CAS Number: 74469-00-4 Current Sponsor code: Amoxicillin Other descriptive name: Amoxicillin Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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. 2. Male or female 18 years old or older. 3. 10 days or more of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after value surgery. 4. Temperature inferior to 38ºC for more than two days. 5. C-reactive protein dropped to =65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: 1. Body mass index >40 2. Concomitant infection requiring intravenous antibiotic therapy 3. Inability to give informed consent to participation 4. Suspicion of reduced absorption of oral treatment due to abdominal disorder 5. Microorganisms with no oral combinations for treatment (two active antibiotics of different families) 6. Any immunosuppressive disease or any medical condition at the discretion of the investigator that may preclude oral or OPAT therapy 7. No family or appropriate home support 8. Reduced compliance 9. Women of childbearing potential with a positive pregnancy test, or participants (male or female) who wish to plan a pregnancy during the trial period 10. Women in lactancy period

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: To demonstrate the non-inferiority of oral treatment compared to OPAT in selected patients - To evaluate quality of life and patient satisfaction - To evaluate costs of both interventions through a pharmacoeconomic analysis - To evaluate complications related to parenteral and oral administration of antibiotics, such as antibiotic or catheter-related adverse events e.g., phlebitis and line-related bloodstream infections, and superinfections e.g., Clostridium difficile diarrhea.;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: 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	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: To demonstrate the non-inferiority of oral treatment compared to OPAT in selected patients - To evaluate quality of life and patient satisfaction - To evaluate costs of both interventions through a pharmacoeconomic analysis - To evaluate complications related to parenteral and oral administration of antibiotics, such as antibiotic or catheter-related adverse events e.g., phlebitis and line-related bloodstream infections, and superinfections e.g., Clostridium difficile diarrhea.;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: 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

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Secondary

Measure	Time frame
Secondary end point(s): 1. To evaluate quality of life and patient satisfaction (test). 2. To evaluate costs of both interventions through a pharmacoeconomic analysis. 3. To evaluate number complications related to parenteral administration and oral administration of antibiotics (such as catheter related infections, Cl difficile diarrhea,among others). 4. number Unplanned hospitalization, all-cause mortality, unplanned cardiac surgery and relapse of IE rates for each variable;Timepoint(s) of evaluation of this end point: 1. To evaluate quality of life and patient satisfaction (test). 2. To evaluate costs of both interventions through a pharmacoeconomic analysis. 3. To evaluate number complications related to parenteral administration and oral administration of antibiotics (such as catheter related infections, Cl difficile diarrhea,among others). 4. number Unplanned hospitalization, all-cause mortality, unplanned cardiac surgery and relapse of IE rates for each variable	—

Measure

Time frame

Secondary end point(s): 1. To evaluate quality of life and patient satisfaction (test). 2. To evaluate costs of both interventions through a pharmacoeconomic analysis. 3. To evaluate number complications related to parenteral administration and oral administration of antibiotics (such as catheter related infections, Cl difficile diarrhea,among others). 4. number Unplanned hospitalization, all-cause mortality, unplanned cardiac surgery and relapse of IE rates for each variable;Timepoint(s) of evaluation of this end point: 1. To evaluate quality of life and patient satisfaction (test). 2. To evaluate costs of both interventions through a pharmacoeconomic analysis. 3. To evaluate number complications related to parenteral administration and oral administration of antibiotics (such as catheter related infections, Cl difficile diarrhea,among others). 4. number Unplanned hospitalization, all-cause mortality, unplanned cardiac surgery and relapse of IE rates for each variable

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Countries

Spain

Contacts

Public ContactAnna Cruceta

CTU

acruceta@clinic.cat

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 5, 2026