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NCT Number: NCT06423898

Ampicillin and Ceftriaxone for the Treatment of Enterococcus Faecalis Infective Endocarditis.

Phase IV, open-label, randomized and multicenter clinical trial to prove that patients with Enterococcus faecalis infective endocarditis treated with an antibiotic treatment as a continuous infusion is non-inferior to the standard treatment, usually administered in hospitalized patients.

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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 Universitario de Álava, Alava, Spain

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About this study

The aim of the study is to prove that the continuous infusion of antibiotic treatment for the patients with Enterococcus faecalis infective endocarditis is as effective and safe as the standard treatment. The continuous infusion modality of treatment is expected to provide numerous benefits for individual patients, global health, and for the National Health Care System by reducing to hospital stays from 4-6 weeks to approximately 2-3 weeks and hospital-driven complications.

The mortality, rate of serious adverse events, total number of days of antibiotic treatment and days of hospitalization, among others, are included as secondary objectives.

This is a pragmatic study as the number or visits performed for the study are similar to the normal clinical follow-up for this patients. Final contact and final visit for the study will be performed at 365 days after the 42 days of treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients
  • Possible or definitive diagnosis of infective endocarditis due to Enterococcus faecalis
  • Signed informed consent of patients

Exclusion criteria

  • Allergy to penicillins or cephalosporins
  • Pregnancy and lactation
  • Polymicrobial infection including microorganisms different to E. faecalis

Treatment and study plan

Ampicillin plus ceftriaxone in continuous infusion

Drug

Continuous intravenous antibiotic infusion during 42 days for Infective Endocarditis

Other names: Experimental regimen

Ampicillin plus ceftriaxone in intermittent infusion of 14 days, after which the treatment may be changed

Drug

Ampicillin plus ceftriaxone as an intermittent infusion for a minimum of 14 days. After, if the patient is discharged from the hospital, the following treatments, until the 42-day treatment period is completed:

  • Intravenous treatment according to the following regimens:

Ampicillin plus ceftriaxone as an intermittent infusion, teicoplanin, daptomycin, dalbavancin or linezolid.

  • Oral treatment according to the following regimens: amoxicillin plus moxifloxacin, amoxicillin plus linezolid, amoxicillin plus rifampin, linezolid plus moxifloxacin or linezolid plus rifampin.

Other names: Control regimen

Primary outcomes

  1. Clinical failure

    Time frame: One year after the end of the treatment

    It is defined as follow:

    i) Confirmed recurrence of E. faecalis infective endocarditis, ii) all-cause mortality. A composite primary endpoint has been chosen to include both a very clinically relevant variable and a hard variable such as survival

Secondary outcomes

  1. Therapeutic failure

    Time frame: Up to 12 months after treatment administration

    Number of deaths

  2. Cardiac surgeries

    Time frame: Up to 12 months after treatment administration

    Number of unplanned cardiac surgeries

  3. Readmissions

    Time frame: Up to 12 months after treatment administration

    Number of unplanned readmissions

  4. Adverse events

    Time frame: From randomisation until 30 days after the last dose administration

    Number of medication-related adverse events

  5. Antibiotic treatment days

    Time frame: Up to 12 months after treatment administration

    Number of antibiotic treatment days

  6. Outpatient Parenteral Antimicrobial Therapy

    Time frame: Up to 12 months after treatment administration

    Number of Outpatient Parenteral Antimicrobial Therapy

  7. Healthcare-associated infections

    Time frame: Up to 12 months after treatment administration

    Number of healthcare-associated infections

  8. Recurrence

    Time frame: Up to 12 months after treatment administration

    Number of recurrence of Enterococcus faecalis infective endocarditis

  9. Minimum free serum concentration

    Time frame: Day 14

    Minimum free serum concentration of antibiotics used

  10. Steady-state plasma concentration

    Time frame: Day 14

    Steady-state plasma concentration of antibiotics used

  11. Pharmacokinetic parameters

    Time frame: Day 14

    Volume of distribution, clearance, elimination constant of antibiotics used

  12. Minimum Inhibitory Concentration

    Time frame: Day 14

    Minimum Inhibitory Concentration of ampicillin induced by ceftriaxone in the strains responsible for recurrences and control strains

Study contacts

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

Clara M Rosso Fernández, MD-PhD

CONTACT

[email protected]

+34955013414

Laura Herrera Hidalgo, MD-PhD

CONTACT

[email protected]

+34955013414

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Collaborators

  • Spanish Clinical Research Network - SCReN

Registry information

Official study title

Efficacy and Safety of Ampicillin and Ceftriaxone Continuous Infusion Versus Standard Therapy for the Treatment of Enterococcus Faecalis Infective Endocarditis (DOβLEI Study)

Acronym: DOBLEI

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 21, 2024
Registry last updated
Jul 25, 2025

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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