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Pill power: could oral antibiotics replace IVs for serious heart infections?

NCT ID NCT02701608

Disease control Sponsor: University Hospital, Tours Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested whether patients with a serious heart valve infection (endocarditis) caused by staph bacteria could safely switch from intravenous (IV) antibiotics to oral pills after at least 10 days of IV treatment. The trial involved 162 adults with left-sided endocarditis. The goal was to see if the oral switch was as effective as continuing IV therapy, potentially allowing patients to leave the hospital earlier and reduce risks like hospital-acquired infections.

What this could mean

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

Active substance
levofloxacin and rifampicin (oral antibiotics)
What this could lead to
If successful, this could allow patients with certain heart infections to finish treatment at home with pills instead of staying in the hospital for IV antibiotics.
What could go wrong
This is a completed Phase 3 trial, but it only included patients with bacteria sensitive to the oral drugs. Results may not apply to all endocarditis cases, and oral antibiotics may not be as effective for everyone.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

162 people

The number who actually took part.

Started

Feb 2016

Finished

Dec 2024

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 IE (Defined according to Duke criteria) on native or prosthetic valve * due to one isolate of Staphylococcus sp. (S. aureus or coagulase negative staphylococci, CNS) susceptible to levofloxacin and rifampicin * in an adult ≥18 year old * appropriate parenteral antibiotics treatment received for at least 10 days * in case of valvular surgery, appropriate parenteral antibiotics treatment received for at least 10 days after valvular surgery * planned duration of antibiotics will extend for at least 14 days at the time of randomisation i.e. a potential switch to oral treatment between Day 10 and Day 28 thus ensuring to have at least 14 days of oral therapy remaining in the experimental group * apyrexia (temperature \< 38°C) at each time point during the last 48 hours (at least two measures/day) at the time of randomisation * blood cultures have been sterile for at least 5 days at the time of randomisation * informed, written consent obtained from patient * subject covered by or having the rights to French social security Exclusion Criteria: * body mass index \<15 kg/m² or \> 40 kg/m² * glomerular filtration rate \< 50 ml/min/1,73m² * patient unable or unwilling to take oral treatment (digestive intolerance, significant malabsorption) at the time of randomisation * expected difficulties regarding compliance with oral antibiotic treatment or follow-up (e.g. severe cognitive impairment, severe psychiatric disease...) * patient without entourage to support and watch him at discharge * valvular surgery planned within the next 6 months * patients with cardiac devices (pace-maker, implantable cardiac defibrillator) and suspected device-related IE (vegetation on the leads) if removal of the device was not performed * breast feeding or pregnant women, or women on childbearing age without effective contraception * expected duration of follow-up \< 7 months at the time of randomisation (e.g. expected life expectancy \< 7 months, patient living abroad...) * past medical history of IE in the last 3 months * other infection requiring parenteral antibiotic therapy * taking of an estrogen-progesterone treatment interacting with rifampicin * patient with contra-indication to oral antibiotics administered in the experimental arm (i.e. fluoroquinolones or rifampicin ) - including anticipated non-manageable drug interactions with rifampicin, and allergy.

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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.

Infective endocarditis

Contacts and locations

Locations

  • APHP BICETRE - Service des maladies infectieuses et tropicales

    Le Kremlin-Bicêtre, 94275, France

  • APHP Henri-Mondor - Service des maladies infectieuses et tropicales

    Créteil, 94010, France

  • APHP St Antoine

    Paris, 75011, France

  • CH PAU - Service de Médecine interne et Maladies infectieuses

    Pau, 64000, France

  • CH QUIMPER - Service d'infectiologie

    Quimper, 29107, France

  • CHU ANGERS - Service des maladies infectieuses et tropicales

    Angers, 49100, France

  • CHU St Etienne - Service des maladies infectieuses et tropicales

    Saint-Priest-en-Jarez, 42270, France

  • CHU Toulouse (Rangueil) Service de Cardiologie

    Toulouse, 31400, France

  • Clinique de la Sauvegarde

    Lyon, 69337, France

  • Consultation de Médecine Interne, maladies infectieuses et tropicales, CH intercommunal de Villeneuve St Georges

    Villeneuve-Saint-Georges, 94190, France

  • Département d'infectiologie, Complexe Bocage, Hôpital d'enfants, CHU de Dijon

    Dijon, 21079, France

  • Infectiologie, médecine interne et médecine des voyages, CH d'Annecy

    Pringy, 74374, France

  • Institut Mutualiste Montsouris - Service de médecine interne

    Paris, 75674, France

  • Médipôle Lyon Villeurbanne

    Villeurbanne, 69625, France

  • Service Maladies Infectieuses et tropicales, Hôpital Côte de Nacre, CHU de Caen

    Caen, 14033, France

  • Service Universitaire des Maladies Infectieuses et du voyageur, CH de Tourcoing

    Tourcoing, 59208, France

  • Service d'Infectiologie, Hôpital de l'Archet, CHU de Nice

    Nice, 06200, France

  • Service de Cardiologie, Hôpitall Louis Pradel, Hôpitaux Est, Hospices Civils de Lyon

    Bron, 69677, France

  • Service de Maladies infectieuses et tropicales, Hôpital Hôtel Dieu, CHU Nantes

    Nantes, 44093, France

  • Service de Maladies infectieuses et tropicales, Hôpital Necker, APHP

    Paris, 75018, France

  • Service de Maladies infectieuses et tropicales, Hôpital de la Source, CHR Orléans

    Orléans, 45100, France

  • Service de Maladies infectieuses et tropicales, Hôpitaux de Brabois, CHU de Nancy

    Vandœuvre-lès-Nancy, 54511, France

  • Service de Maladies infectieuses et tropicales, médecine interne, CH de Chambéry

    Chambéry, 73011, France

  • Service de Maladies infectieuses, parasitaires et tropicales, Hôpital Bichat, APHP

    Paris, 75018, France

  • Service de Microbiologie, Hôpital Européen Georges Pompidou, APHP

    Paris, 75015, France

  • Service de Médecine aigue spécifique, Hôpital Raymond Poincaré, APHP

    Garches, 92380, France

  • Service de Médecine infectieuse, Hôpital Nord Michallon, CHU de Grenoble

    La Tronche, 38700, France

  • Service de Médecine interne et maladies infectieuses, Hôpital Bretonneau, CHU de Tours

    Tours, 37044, France

  • Service de Médecine interne polyvalente et neurologique CH de Douai

    Douai, 59507, France

  • Service de Médecine interne, Hôpital Ambroise Paré, APHP

    Boulogne-Billancourt, 92104, France

  • Service de Médecine interne, maladies infectieuses et tropicales, CHU de Poitiers

    Poitiers, 86021, France

  • Service de Médecine interne, maladies infectieuses, immunologie clinique, Hôpital R. Debré, CHU de Reims

    Reims, 51092, France

  • Service de Médecine post-urgence, infectiologie, Site de la Roche sur Yon, CHD Vendée

    La Roche-sur-Yon, 85025, France

  • Service de Pathologies infectieuses et tropicales, Hôpital Nord, CHU d'Amiens

    Amiens, 80054, France

  • Service de Réanimation médicale, Hôpital St André, CHU de Bordeaux

    Bordeaux, 33000, France

  • Service des Maladies Infectieuses et Tropicales, Hôpital Carémeau, CHU de Nîmes

    Nîmes, 30029, France

  • Service des Maladies infectieuses et Tropicales, Hôpital Jean Minjoz, CHU de Besançon

    Besançon, 25030, France

  • Service des Maladies infectieuses et tropicales, CH Le Mans

    Le Mans, 72037, France

  • Service des Maladies infectieuses et tropicales, Hôpital Charles Nicolle, CHU de Rouen

    Rouen, 76031, France

  • Service des Maladies infectieuses et tropicales, Hôpital de Purpan, CHU de Toulouse

    Toulouse, 31059, France

  • Service des Maladies infectieuses, CH de Niort

    Niort, 79021, France

  • Service des maladies infectieuses et réanimation médicale, Hôpital Pontchaillou, CHU de Rennes

    Rennes, 35033, France

  • Service des maladies infectieuses et tropicales, Hôpital G. Montpied, CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003, France

  • Service des maladies respiratoires et infectieuses, CH de St Malo

    St-Malo, 35403, France

  • Unité médicale d'infectiologie, Hôpital Huriez, CHU de Lille

    Lille, 59037, France

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