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NCT Number: NCT05398679

Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

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

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Key information

Conditions

Endocarditis Infective Cardiovascular Diseases Endocarditis Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital General de Alicante, Alicante, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefaclor

Drug

cefaclor intravenous 2 gr/day

Ciprofloxacin Tablets

Drug

500-750 mg/12 hrs (maximum 3g x day)

Ciprofloxacin Injection

Drug

1200 mg/day maximum dose IV

Clindamycin Oral Capsule

Drug

600 mg/8 hours (maximum 1.800 mg x day)

Clindamycin Injection

Drug

600 mg/8 hours (maximum 1.800 mg x day) IV

Dicloxacillin Oral Capsule

Drug

1g/8 hours (maximum 4 gr day)

Dicloxacillin

Drug

1g/8 hours (maximum 4 g x day) IV

Fusidic Acid Only Product in Oral Dose Form

Drug

0,750g/12 hours (maximum 1,5 g x day)

Fusidic Acid Only Product in Parenteral Dose Form

Drug

0,75 g/12 hours (maximum 1,5 g x day)

Levofloxacin Oral Tablet

Drug

0.5g/12-24hours (maximum 1 g x day)

Levofloxacin Injection

Drug

0.5g/12-24hours (maximum 1 g x day)

Linezolid Oral Tablet

Drug

0,6 g/12 hours (maximum 1200 mg x day)

Linezolid Injectable Product

Drug

0,6 g/12 hours (maximum 1200 mg x day)

Moxifloxacin tablet

Drug

0,4 g/day (maximum 400 mg x day)

Moxifloxacin Injectable Product

Drug

0,4 g/day (maximum 400 mg x day)

Rifampicin Only Product in Oral Dose Form

Drug

0,3-0,5 g/12 hours (maximum 1200 mg x day)

Rifampicin Only Product in Parenteral Dose Form

Drug

0,3-0,6 g/12 hours (maximum 1200 mg x day)

Sulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]

Drug

sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)

Sulfamethoxazole / Trimethoprim Injectable Product

Drug

sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)

Tedizolid Oral Tablet

Drug

200 mg tedizolid (maximum x day)

Tedizolid Injection

Drug

200 mg (maximum x day)

Amoxicillin Capsules

Drug

1 gr/6 hours (4 g x day)

Amoxicillin

Drug

1 gr/6 hours (4 g x day) Intravenous

Cefaclor Capsules

Drug

2 gr/day

Primary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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)

Secondary outcomes

  1. 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)

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Cruceta

CONTACT

[email protected]

+34 932275400 ext. 4380

Laura Burunat

CONTACT

[email protected]

+34 932275400 ext. 4198

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Registry information

Acronym: OraPAT-IEGAMES

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jun 1, 2022
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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