Infective EndocarditisPhase 3NCT02701608
Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Staphylococcus
A Phase 3 study testing Levofloxacin, Rifampicin and Conventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicine in people with Infective Endocarditis, run by University Hospital, Tours at 45 sites in France.
Trial summary
Infective endocarditis (IE) is a serious infection with a significant burden for patients and hospitals (in France, median length of hospital stay = 43 days), partly due to the long duration of intravenous (IV) antibacterial treatment recommended by international guidelines, between 4 and 6 weeks in most situations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis
- What is being tested?
- Levofloxacin, Rifampicin and Conventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 45 sitesFrance
- Study dates
- 29 Feb 2016to 4 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
France45 sites
Service de Pathologies infectieuses et tropicales, Hôpital Nord, CHU d'Amiens
Amiens, 80054
CHU ANGERS - Service des maladies infectieuses et tropicales
Angers, 49100
Service des Maladies infectieuses et Tropicales, Hôpital Jean Minjoz, CHU de Besançon
Besançon, 25030
Service de Réanimation médicale, Hôpital St André, CHU de Bordeaux
Bordeaux, 33000
Service de Médecine interne, Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, 92104
Service de Cardiologie, Hôpitall Louis Pradel, Hôpitaux Est, Hospices Civils de Lyon
Bron, 69677
Service Maladies Infectieuses et tropicales, Hôpital Côte de Nacre, CHU de Caen
Caen, 14033
Service de Maladies infectieuses et tropicales, médecine interne, CH de Chambéry
Chambéry, 73011
Service des maladies infectieuses et tropicales, Hôpital G. Montpied, CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
APHP Henri-Mondor - Service des maladies infectieuses et tropicales
Créteil, 94010
Département d'infectiologie, Complexe Bocage, Hôpital d'enfants, CHU de Dijon
Dijon, 21079
Service de Médecine interne polyvalente et neurologique CH de Douai
Douai, 59507
Service de Médecine aigue spécifique, Hôpital Raymond Poincaré, APHP
Garches, 92380
Service de Médecine post-urgence, infectiologie, Site de la Roche sur Yon, CHD Vendée
La Roche-sur-Yon, 85025
Service de Médecine infectieuse, Hôpital Nord Michallon, CHU de Grenoble
La Tronche, 38700
APHP BICETRE - Service des maladies infectieuses et tropicales
Le Kremlin-Bicêtre, 94275
Service des Maladies infectieuses et tropicales, CH Le Mans
Le Mans, 72037
Unité médicale d'infectiologie, Hôpital Huriez, CHU de Lille
Lille, 59037
Clinique de la Sauvegarde
Lyon, 69337
Service de Maladies infectieuses et tropicales, Hôpital Hôtel Dieu, CHU Nantes
Nantes, 44093
Service d'Infectiologie, Hôpital de l'Archet, CHU de Nice
Nice, 06200
Service des Maladies Infectieuses et Tropicales, Hôpital Carémeau, CHU de Nîmes
Nîmes, 30029
Service des Maladies infectieuses, CH de Niort
Niort, 79021
Service de Maladies infectieuses et tropicales, Hôpital de la Source, CHR Orléans
Orléans, 45100
APHP St Antoine
Paris, 75011
Service de Microbiologie, Hôpital Européen Georges Pompidou, APHP
Paris, 75015
Service de Maladies infectieuses et tropicales, Hôpital Necker, APHP
Paris, 75018
Service de Maladies infectieuses, parasitaires et tropicales, Hôpital Bichat, APHP
Paris, 75018
Institut Mutualiste Montsouris - Service de médecine interne
Paris, 75674
CH PAU - Service de Médecine interne et Maladies infectieuses
Pau, 64000
Service de Médecine interne, maladies infectieuses et tropicales, CHU de Poitiers
Poitiers, 86021
Infectiologie, médecine interne et médecine des voyages, CH d'Annecy
Pringy, 74374
CH QUIMPER - Service d'infectiologie
Quimper, 29107
Service de Médecine interne, maladies infectieuses, immunologie clinique, Hôpital R. Debré, CHU de Reims
Reims, 51092
Service des maladies infectieuses et réanimation médicale, Hôpital Pontchaillou, CHU de Rennes
Rennes, 35033
Service des Maladies infectieuses et tropicales, Hôpital Charles Nicolle, CHU de Rouen
Rouen, 76031
CHU St Etienne - Service des maladies infectieuses et tropicales
Saint-Priest-en-Jarez, 42270
Service des maladies respiratoires et infectieuses, CH de St Malo
St-Malo, 35403
Service des Maladies infectieuses et tropicales, Hôpital de Purpan, CHU de Toulouse
Toulouse, 31059
CHU Toulouse (Rangueil) Service de Cardiologie
Toulouse, 31400
Service Universitaire des Maladies Infectieuses et du voyageur, CH de Tourcoing
Tourcoing, 59208
Service de Médecine interne et maladies infectieuses, Hôpital Bretonneau, CHU de Tours
Tours, 37044
Service de Maladies infectieuses et tropicales, Hôpitaux de Brabois, CHU de Nancy
Vandœuvre-lès-Nancy, 54511
Consultation de Médecine Interne, maladies infectieuses et tropicales, CH intercommunal de Villeneuve St Georges
Villeneuve-Saint-Georges, 94190
Médipôle Lyon Villeurbanne
Villeurbanne, 69625
About this study
Official title: Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Staphylococcus (Relais Oral Dans le Traitement Des Endocardites à Staphylocoques Multi-sensibles)
Infective endocarditis (IE) is a serious infection with a significant burden for patients and hospitals (in France, median length of hospital stay = 43 days), partly due to the long duration of intravenous (IV) antibacterial treatment recommended by international guidelines, between 4 and 6 weeks in most situations.
A recent survey of practices regarding the management of IE in France showed that a switch from IV to oral antibiotics is feasible, when patients with left-sided Staphylococcus IE are stable after an initial course of IV antibiotic treatment, with or without valvular surgery.
Read more
These practices have not been associated with unfavourable outcome, while significantly reducing the duration and cost of hospitalization, the risk of nosocomial infection, and patients' discomfort.
There has been no randomized controlled trial (RCT) in the field of IE over the last 20 years; current guidelines are mostly based on expert advice, in vitro studies, animal experiments, or clinical studies performed before the 90's.
The RODEO 1 project is an unprecedented opportunity to bring back evidence-based medicine in the field of IE.
Most experts acknowledge that the pharmacological PK/PD characteristics of antibiotics such as fluoroquinolones and rifampicin allow a high level of efficacy in the treatment of IE when orally administrated after an IV period of induction.
It's needed to conduct RCTs that clearly demonstrate the clinical non-inferiority of this strategy for multisusceptible staphylococci with a benefit regarding costs.
The RODEO 1 project corresponds to one pragmatic trial assessing the impact of a switch strategy, making it a comparative effectiveness trial that should be able to feed the next revision of IE international guidelines and to change practices in IE management.
Read the detailed description
The RODEO 1 study is designed to determine the safety and efficacy of partial oral treatment of IE compared with traditional full-length parenteral treatment. Our primary objective is to demonstrate that in patients with left-sided multi-susceptible Staphylococcus who have received at least 10 days of IV antibiotic treatment with or without valvular surgery, a switch to an oral combination of rifampicin and fluoroquinolones between Day 10 and Day 28 after initiation of the IV antibiotic treatment, is not inferior to the continuation of the conventional IV antibiotic treatment regarding to treatment failure within 3 months after the end of antibiotic treatment.
Nationwide, noninferiority, multicenter, randomized, controlled, open-label trials.
Randomisation will only be offered to patients who have received at least 10 days of IV conventional antibiotic treatment of IE, and fulfil the inclusion criteria.
Randomisation will take place between Day 10 and Day 28 after initiation of parenteral antibiotic therapy or valvular surgery, thus ensuring to have at least 14 days of oral therapy in the experimental group.
Patients will be eligible whether they have undergone valvular surgery or not. This will imply that surgery procedure prior to randomisation will be heterogeneous, but randomisation will be stratified on the requirement of valvular surgery as part of the treatment of the current episode of IE or not.
- Conditions
- Infective Endocarditis
- Being tested
- Levofloxacin, Rifampicin, Conventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicine
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
Also called Fluoroquinolones
levofloxacin 500 mg x1/day (for patients ≤70kg) or levofloxacin 750 mg x1/day (for patients >70kg)
RifampicinDrug
rifampicin 600mg x1/day (for patients ≤70kg) or rifampicin 900mg x1/day (for patients >70kg)
Conventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicineProcedure or surgery
Conventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicine
| Study group | Role | What they receive |
|---|---|---|
| Oral switch treatment | Experimental | Oral switch to the combination of levofloxacin and rifampicin Receives: Drug: Levofloxacin; Drug: Rifampicin |
| Conventional IV treatment according to european guidelines | Active comparator | Conventional IV treatment of staphylococci IE (European guidelines 2015) Receives: Procedure: Conventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
Failure is a composite outcome defined by death from all causes and/or symptomatic embolic events and/or unplanned valvular surgery and/or a microbiological relapse (with the primary pathogen).
Measured: up to 3 months after the end of antibiotic treatment
Secondary outcomes (18)
death from all-cause
death from all-cause
Measured: up to 6 months after the end of antibiotic treatment
number of symptomatic embolic events
secondary osteo-articular, splenic or brain localization
Measured: up to 6 months after the end of antibiotic treatment
unplanned valvular surgery
unplanned valvular surgery
Measured: up to 6 months after the end of antibiotic treatment
relapse of positive blood cultures
relapse of positive blood cultures with the primary pathogen
Measured: up to 6 months after the end of antibiotic treatment
microbiological relapse with a different pathogen from the primary pathogen
Relapse of positive blood cultures with a different pathogen within 3 months after the end of antibiotic therapy
Measured: up to 6 months after the end of antibiotic treatment
Echocardiography
An apparition, an increase or decrease of the following items: vegetation, abscess, perforation, fistula, dehiscence of a prosthetic valve, will be searched at each ultrasound examination at : the end of antibiotic treatment, at 3 months and 6 months after the end of antibiotic treatment
Measured: up to 6 months after the end of antibiotic treatment
Catheter related adverse events
Catheter-related AE: infectious (e.g. catheter-related bacteraemia) or non-infectious catheter-related complications (e.g. extravasation).
Measured: up to 6 months after the end of antibiotic treatment
other healthcare-acquired infections
other healthcare-acquired infections, including urinary tract infections, pneumonia, surgical site infection, Clostridium difficile infections
Measured: up to 6 months after the end of antibiotic treatment
Number of participants with an antibiotic modification
All change regarding antibiotic treatment administered will be recorded (drug, dose or duration)
Measured: up to the end of antibiotic treatment
Quality of life
An assessment of patient's quality of life will be done at the end of antibiotic treatment, at 3 months and 6 months after the end of antibiotic treatment, using the EuroQol Five Dimensions (EQ5D3L)
Measured: up to 6 months after the end of antibiotic treatment
number of participants with a switch back from oral to IV antibiotic treatment
For experimental group only . An assessment of the need for a return to parenteral antibiotic in the experimental group.
Measured: up to the end of antibiotic treatment
Compliance with oral antibiotic treatment
For experimental group only. The assessment of compliance with oral antibiotic treatment will be carried out at each visit during the treatment period.
Measured: up to 4 weeks after randomisation
Cost per patient
Analysis using data from three centers (Tours, Rennes, Nancy) to compare both strategy (oral switch vs. pan-IV) for the cost per patient
Measured: up to 6 months after the end of antibiotic treatment
Budget impact analysis (BIA)
With data from three centers (Tours, Nancy, Rennes). With data from three centers (Tours, Nancy, Rennes). Allow to estimate the financial consequences of the adoption and diffusion of a new health intervention (the oral strategy). BIA must be calculated on a yearly basis.
Measured: up to 6 months after the end of antibiotic treatment
Utility score and incremental cost-utility ratio (ICUR)
With data from all centers. An assessment of the health related quality of life of the patient will be carried out using a simple generic questionnaire, the EuroQol Five Dimensions (EQ5D3L), recommended by the Washington Panel on Cost Effectiveness (utility) in Health and Medicine, with a cardinal scale and validated French version (http://www.euroqol.org)Quality of life will be assessed 4 times: at baseline, at the end of antibiotic treatment, at 3 months after end of antibiotic treatment and at the final visit.
Measured: up to 6 months after the end of antibiotic treatment
Length of hospital stay
With data from all centers. Length of hospital stay will be calculated as duration between day of start of hospitalization and day of discharge (distinguishing rehabilitation care unit). In case a patient dies during hospitalization, death will be considered as a competing event to discharge.
Measured: up to 6 months after the end of antibiotic treatment
Residual concentration of antibiotics
Pharmacokinetic analysis for the experimental group only: residual concentrations of levofloxacin and rifampicin, or amoxicillin, after 7 days of oral treatment (i.e. at visit 2).
Measured: 7 days
Biological collection for further analysis on endocarditis
A biological collection will be constituted in order to perform further biological and genetic analysis of endocarditis (i.e. inflammatory markers of efficacy and genetic markers that predispose to endocarditis).
Measured: up to 6 months after the end of antibiotic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study start29 Feb 2016
- Primary completion15 Aug 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis BERNARD, MD,PHD, Principal investigator, CHRU TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701608
- Sponsor's protocol ID
- RODEO 1
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2016
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: There are no plans to grant public access to the full protocol, participant-level data or statistical code. Data from the RODEO trials is stored by the promotor of the trial. Data and the personal identifiers are stored separately and a special permit is required for access to the data. Data can be available on request for academic researchers when it have been analysed and published. Qualified researchers can ask for data sharing by the first author LB after the study finalization. Open Access This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work noncommercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http:// creativecommons.org/licenses/by-nc/4.0/
Publications
Lemaignen A, Bernard L, Tattevin P, Bru JP, Duval X, Hoen B, Brunet-Houdard S, Mainardi JL, Caille A; RODEO (Relais Oral Dans le traitement des Endocardites a staphylocoques ou streptOcoques) and AEPEI (Association pour l'Etude et la Prevention de l'Endocardite Infectieuse) study groups. Oral switch versus standard intravenous antibiotic therapy in left-sided endocarditis due to susceptible staphylococci, streptococci or enterococci (RODEO): a protocol for two open-label randomised controlled trials. BMJ Open. 2020 Jul 14;10(7):e033540. doi: 10.1136/bmjopen-2019-033540.
PubMed 32665381
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Staphylococcus (Relais Oral Dans le Traitement Des Endocardites à Staphylocoques Multi-sensibles)
- ClinicalTrials.gov ID
- NCT02701608
- Acronym / sponsor ID
- RODEO 1
- Conditions
- Infective Endocarditis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infective endocarditis (IE) is a serious infection with a significant burden for patients and hospitals (in France, median length of hospital stay = 43 days), partly due to the long duration of intravenous (IV) antibacterial treatment recommended by international guidelines, between 4 and 6 weeks in most situations.
A recent survey of practices regarding the management of IE in France showed that a switch from IV to oral antibiotics is feasible, when patients with left-sided Staphylococcus IE are stable after an initial course of IV antibiotic treatment, with or without valvular surgery.
These practices have not been associated with unfavourable outcome, while significantly reducing the duration and cost of hospitalization, the risk of nosocomial infection, and patients' discomfort.
There has been no randomized controlled trial (RCT) in the field of IE over the last 20 years; current guidelines are mostly based on expert advice, in vitro studies, animal experiments, or clinical studies performed before the 90's.
The RODEO 1 project is an unprecedented opportunity to bring back evidence-based medicine in the field of IE.
Most experts acknowledge that the pharmacological PK/PD characteristics of antibiotics such as fluoroquinolones and rifampicin allow a high level of efficacy in the treatment of IE when orally administrated after an IV period of induction.
It's needed to conduct RCTs that clearly demonstrate the clinical non-inferiority of this strategy for multisusceptible staphylococci with a benefit regarding costs.
The RODEO 1 project corresponds to one pragmatic trial assessing the impact of a switch strategy, making it a comparative effectiveness trial that should be able to feed the next revision of IE international guidelines and to change practices in IE management.
Detailed description
The RODEO 1 study is designed to determine the safety and efficacy of partial oral treatment of IE compared with traditional full-length parenteral treatment. Our primary objective is to demonstrate that in patients with left-sided multi-susceptible Staphylococcus who have received at least 10 days of IV antibiotic treatment with or without valvular surgery, a switch to an oral combination of rifampicin and fluoroquinolones between Day 10 and Day 28 after initiation of the IV antibiotic treatment, is not inferior to the continuation of the conventional IV antibiotic treatment regarding to treatment failure within 3 months after the end of antibiotic treatment.
Nationwide, noninferiority, multicenter, randomized, controlled, open-label trials.
Randomisation will only be offered to patients who have received at least 10 days of IV conventional antibiotic treatment of IE, and fulfil the inclusion criteria.
Randomisation will take place between Day 10 and Day 28 after initiation of parenteral antibiotic therapy or valvular surgery, thus ensuring to have at least 14 days of oral therapy in the experimental group.
Patients will be eligible whether they have undergone valvular surgery or not. This will imply that surgery procedure prior to randomisation will be heterogeneous, but randomisation will be stratified on the requirement of valvular surgery as part of the treatment of the current episode of IE or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral switch treatment | Experimental | Drug: Levofloxacin, Drug: RifampicinOral switch to the combination of levofloxacin and rifampicin |
| Conventional IV treatment according to european guidelines | Active comparator | Procedure: Conventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicineConventional IV treatment of staphylococci IE (European guidelines 2015) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevofloxacinAlso: Fluoroquinoloneslevofloxacin 500 mg x1/day (for patients ≤70kg) or levofloxacin 750 mg x1/day (for patients >70kg) | Drug | Oral switch treatment |
| Rifampicinrifampicin 600mg x1/day (for patients ≤70kg) or rifampicin 900mg x1/day (for patients >70kg) | Drug | Oral switch treatment |
| Conventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicineConventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicine | Procedure or surgery | Conventional IV treatment according to european guidelines |
Primary outcome
Treatment failure
Time frame: up to 3 months after the end of antibiotic treatment
Failure is a composite outcome defined by death from all causes and/or symptomatic embolic events and/or unplanned valvular surgery and/or a microbiological relapse (with the primary pathogen).
18 secondary outcomes
death from all-cause
Time frame: up to 6 months after the end of antibiotic treatment
number of symptomatic embolic events
Time frame: up to 6 months after the end of antibiotic treatment
unplanned valvular surgery
Time frame: up to 6 months after the end of antibiotic treatment
relapse of positive blood cultures
Time frame: up to 6 months after the end of antibiotic treatment
microbiological relapse with a different pathogen from the primary pathogen
Time frame: up to 6 months after the end of antibiotic treatment
Echocardiography
Time frame: up to 6 months after the end of antibiotic treatment
Catheter related adverse events
Time frame: up to 6 months after the end of antibiotic treatment
other healthcare-acquired infections
Time frame: up to 6 months after the end of antibiotic treatment
Number of participants with an antibiotic modification
Time frame: up to the end of antibiotic treatment
Quality of life
Time frame: up to 6 months after the end of antibiotic treatment
number of participants with a switch back from oral to IV antibiotic treatment
Time frame: up to the end of antibiotic treatment
Compliance with oral antibiotic treatment
Time frame: up to 4 weeks after randomisation
Cost per patient
Time frame: up to 6 months after the end of antibiotic treatment
Budget impact analysis (BIA)
Time frame: up to 6 months after the end of antibiotic treatment
Utility score and incremental cost-utility ratio (ICUR)
Time frame: up to 6 months after the end of antibiotic treatment
Length of hospital stay
Time frame: up to 6 months after the end of antibiotic treatment
Residual concentration of antibiotics
Time frame: 7 days
Biological collection for further analysis on endocarditis
Time frame: up to 6 months after the end of antibiotic treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Derived from this study: PubMed 32665381Lemaignen A, Bernard L, Tattevin P, Bru JP, Duval X, Hoen B, Brunet-Houdard S, Mainardi JL, Caille A; RODEO (Relais Oral Dans le traitement des Endocardites a staphylocoques ou streptOcoques) and AEPEI (Association pour l'Etude et la Prevention de l'Endocardite Infectieuse) study groups. Oral switch versus standard intravenous antibiotic therapy in left-sided endocarditis due to susceptible staphylococci, streptococci or enterococci (RODEO): a protocol for two open-label randomised controlled trials. BMJ Open. 2020 Jul 14;10(7):e033540. doi: 10.1136/bmjopen-2019-033540.
- Individual participant dataSharing planned: Yes. There are no plans to grant public access to the full protocol, participant-level data or statistical code. Data from the RODEO trials is stored by the promotor of the trial. Data and the personal identifiers are stored separately and a special permit is required for access to the data. Data can be available on request for academic researchers when it have been analysed and published. Qualified researchers can ask for data sharing by the first author LB after the study finalization. Open Access This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work noncommercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http:// creativecommons.org/licenses/by-nc/4.0/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis BERNARD, MD,PHD principal investigator
CHRU TOURS
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levofloxacin, Rifampicin and Conventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicine in people with Infective Endocarditis, run by University Hospital, Tours at 45 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: up to 3 months after the end of antibiotic treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02701608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.