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Pill power: oral antibiotics may match IVs for serious heart infection

NCT ID NCT05398679

Disease control Sponsor: Fundacion Clinic per a la Recerca Biomédica Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study compares oral antibiotics to intravenous (IV) antibiotics for treating infective endocarditis, a serious heart infection. Researchers want to see if taking pills at home works as well as getting IV treatment in a clinic. The trial involves 360 adults with specific types of infections and measures unplanned hospitalizations, deaths, relapses, and need for heart surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
antibiotics (oral and intravenous)
What this could lead to
If successful, this could allow many patients with infective endocarditis to switch from IV to oral antibiotics earlier, reducing hospital stays and improving quality of life.
What could go wrong
This is a non-inferiority trial, so it aims to show oral treatment is not worse than IV, not necessarily better. Results may not apply to all types of infections or patients, and there is a risk of relapse or complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

endocarditis infective endocarditis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endocarditis infective

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Bellvitge

    RECRUITING

    Barcelona, Barcelona, 08907, Spain

  • Hospital Clinic i Provincial de Barcelona

    RECRUITING

    Barcelona, Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Marañón

    RECRUITING

    Madrid, Madrid, 28007, Spain

  • Hospital General de Alicante

    RECRUITING

    Alicante, Alicante, 03010, Spain

  • Hospital Mútua de Terrassa

    RECRUITING

    Terrassa, Barcelona, 08221, Spain

  • Hospital Ramón y Cajal

    RECRUITING

    Madrid, Madrid, 28034, Spain

  • Hospital San Pedro

    RECRUITING

    Logroño, La Rioja, 26006, Spain

  • Hospital Sant Pau

    RECRUITING

    Barcelona, Barcelona, 08041, Spain

  • Hospital Son Espases

    RECRUITING

    Palma de Mallorca, Balearic Islands, 07120, Spain

  • Hospital Universitari i Politècnic La Fe

    NOT_YET_RECRUITING

    Valencia, València, 46009, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, Madrid, 28046, Spain

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario de Cruces

    RECRUITING

    Barakaldo, Bizcaia, 48903, Spain

  • Hospital Universitario de Donostia

    RECRUITING

    Donostia / San Sebastian, Guipuzcoa, 20014, Spain

  • Hospital Virgen de Arrixaca

    RECRUITING

    El Palmar, Murcia, 30120, Spain

  • Hospital Virgen de la Macarena

    RECRUITING

    Seville, Andalusia, 41009, Spain

  • Hospital Virgen del Rocío

    RECRUITING

    Seville, Andalusia, 41013, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, Barcelona, 08003, Spain

  • Hospital universitario de Canarias

    RECRUITING

    San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain

  • Parc Taulí Hospital Universitari

    RECRUITING

    Sabadell, Barcelona, 08208, Spain

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