Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis (OraPAT-IEGAMES)

February 23, 2026 updated by: Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Alicante
      • Alicante, Alicante, Spain, 03010
        • Recruiting
        • Hospital General de Alicante
        • Contact:
    • Andalusia
      • Seville, Andalusia, Spain, 41009
        • Recruiting
        • Hospital Virgen De La Macarena
        • Contact:
      • Seville, Andalusia, Spain, 41013
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07120
        • Recruiting
        • Hospital Son Espases
        • Contact:
    • Barcelona
      • Barcelona, Barcelona, Spain, 08003
      • Barcelona, Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clínic I Provincial de Barcelona
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guillermo Cuervo, MD
      • Barcelona, Barcelona, Spain, 08041
      • Barcelona, Barcelona, Spain, 08907
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Parc Tauli Hospital Universitari
        • Contact:
      • Terrassa, Barcelona, Spain, 08221
        • Recruiting
        • Hospital Mútua de Terrassa
        • Contact:
    • Bizcaia
      • Barakaldo, Bizcaia, Spain, 48903
        • Recruiting
        • Hospital Universitario de Cruces
        • Contact:
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
    • Guipuzcoa
      • Donostia / San Sebastian, Guipuzcoa, Spain, 20014
        • Recruiting
        • Hospital Universitario de Donostia
        • Contact:
    • La Rioja
      • Logroño, La Rioja, Spain, 26006
    • Madrid
      • Madrid, Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
      • Madrid, Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañón
        • Contact:
      • Madrid, Madrid, Spain, 28034
        • Recruiting
        • Hospital Ramon y Cajal
        • Contact:
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Hospital Virgen de Arrixaca
        • Contact:
    • Santa Cruz de Tenerife
      • San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain, 38320
        • Recruiting
        • Hospital Universitario de Canarias
        • Contact:
    • València
      • Valencia, València, Spain, 46009
        • Not yet recruiting
        • Hospital Universitari i Politecnic La Fe
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 10 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OPAT
Patients with infective endocarditis diagnostic, who have completed at least 10 days of intravenous therapy, and/ or seven days in the case of cardiac valvular surgery, and shown good clinical evolution and no clinical or echocardiographic signs of potential bad prognosis will be randomized. If assigned to this arm the patient will recieve parenteral antibiotics until the end of treatment.
Drug: Cefaclor
cefaclor intravenous 2 gr/day
Drug: Ciprofloxacin Injection
1200 mg/day maximum dose IV
Drug: Clindamycin Injection
600 mg/8 hours (maximum 1.800 mg x day) IV
Drug: Dicloxacillin
1g/8 hours (maximum 4 g x day) IV
Drug: Fusidic Acid Only Product in Parenteral Dose Form
0,75 g/12 hours (maximum 1,5 g x day)
Drug: Levofloxacin Injection
0.5g/12-24hours (maximum 1 g x day)
Drug: Linezolid Injectable Product
0,6 g/12 hours (maximum 1200 mg x day)
Drug: Moxifloxacin Injectable Product
0,4 g/day (maximum 400 mg x day)
Drug: Rifampicin Only Product in Parenteral Dose Form
0,3-0,6 g/12 hours (maximum 1200 mg x day)
Drug: Sulfamethoxazole / Trimethoprim Injectable Product
sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
Drug: Tedizolid Injection
200 mg (maximum x day)
Drug: Amoxicillin
1 gr/6 hours (4 g x day) Intravenous
Experimental: Oral Therapy
Patients with infective endocarditis diagnostic, who have completed at least 10 days of intravenous therapy, and/ or seven days in the case of cardiac valvular surgery, and shown good clinical evolution and no clinical or echocardiographic signs of potential bad prognosis will be randomized. If assigned to this arm the patient will recieve oral antibiotics until the end of treatment.
Drug: Ciprofloxacin Tablets
500-750 mg/12 hrs (maximum 3g x day)
Drug: Clindamycin Oral Capsule
600 mg/8 hours (maximum 1.800 mg x day)
Drug: Dicloxacillin Oral Capsule
1g/8 hours (maximum 4 gr day)
Drug: Fusidic Acid Only Product in Oral Dose Form
0,750g/12 hours (maximum 1,5 g x day)
Drug: Levofloxacin Oral Tablet
0.5g/12-24hours (maximum 1 g x day)
Drug: Linezolid Oral Tablet
0,6 g/12 hours (maximum 1200 mg x day)
Drug: Moxifloxacin tablet
0,4 g/day (maximum 400 mg x day)
Drug: Rifampicin Only Product in Oral Dose Form
0,3-0,5 g/12 hours (maximum 1200 mg x day)
Drug: Sulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]
sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
Drug: Tedizolid Oral Tablet
200 mg tedizolid (maximum x day)
Drug: Amoxicillin Capsules
1 gr/6 hours (4 g x day)
Drug: Cefaclor Capsules
2 gr/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Non-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)
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)
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
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)
At any time during the study duration (up to 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
Time Frame: At any time during the study duration (up to 24 months)
through a pharmacoeconomic analysis
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
Time Frame: At any time during the study duration (up to 24 months)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2022

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

May 4, 2022

First Submitted That Met QC Criteria

May 26, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OraPAT-IE GAMES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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