Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Staphylococcus
1 other identifier
interventional
162
1 country
45
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2016
Longer than P75 for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2016
CompletedStudy Start
First participant enrolled
February 29, 2016
CompletedFirst Posted
Study publicly available on registry
March 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2024
CompletedFebruary 12, 2026
February 1, 2026
8.5 years
January 28, 2016
February 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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).
up to 3 months after the end of antibiotic treatment
Secondary Outcomes (18)
death from all-cause
up to 6 months after the end of antibiotic treatment
number of symptomatic embolic events
up to 6 months after the end of antibiotic treatment
unplanned valvular surgery
up to 6 months after the end of antibiotic treatment
relapse of positive blood cultures
up to 6 months after the end of antibiotic treatment
microbiological relapse with a different pathogen from the primary pathogen
up to 6 months after the end of antibiotic treatment
- +13 more secondary outcomes
Study Arms (2)
Oral switch treatment
EXPERIMENTALOral switch to the combination of levofloxacin and rifampicin
Conventional IV treatment according to european guidelines
ACTIVE COMPARATORConventional IV treatment of staphylococci IE (European guidelines 2015)
Interventions
levofloxacin 500 mg x1/day (for patients ≤70kg) or levofloxacin 750 mg x1/day (for patients \>70kg)
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,rifampicine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Service de Pathologies infectieuses et tropicales, Hôpital Nord, CHU d'Amiens
Amiens, 80054, France
CHU ANGERS - Service des maladies infectieuses et tropicales
Angers, 49100, France
Service des Maladies infectieuses et Tropicales, Hôpital Jean Minjoz, CHU de Besançon
Besançon, 25030, France
Service de Réanimation médicale, Hôpital St André, CHU de Bordeaux
Bordeaux, 33000, France
Service de Médecine interne, Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, 92104, France
Service de Cardiologie, Hôpitall Louis Pradel, Hôpitaux Est, Hospices Civils de Lyon
Bron, 69677, France
Service Maladies Infectieuses et tropicales, Hôpital Côte de Nacre, CHU de Caen
Caen, 14033, France
Service de Maladies infectieuses et tropicales, médecine interne, CH de Chambéry
Chambéry, 73011, France
Service des maladies infectieuses et tropicales, Hôpital G. Montpied, CHU de Clermont-Ferrand
Clermont-Ferrand, 63003, France
APHP Henri-Mondor - Service des maladies infectieuses et tropicales
Créteil, 94010, France
Département d'infectiologie, Complexe Bocage, Hôpital d'enfants, CHU de Dijon
Dijon, 21079, France
Service de Médecine interne polyvalente et neurologique CH de Douai
Douai, 59507, France
Service de Médecine aigue spécifique, Hôpital Raymond Poincaré, APHP
Garches, 92380, France
Service de Médecine post-urgence, infectiologie, Site de la Roche sur Yon, CHD Vendée
La Roche-sur-Yon, 85025, France
Service de Médecine infectieuse, Hôpital Nord Michallon, CHU de Grenoble
La Tronche, 38700, France
APHP BICETRE - Service des maladies infectieuses et tropicales
Le Kremlin-Bicêtre, 94275, France
Service des Maladies infectieuses et tropicales, CH Le Mans
Le Mans, 72037, France
Unité médicale d'infectiologie, Hôpital Huriez, CHU de Lille
Lille, 59037, France
Clinique de la Sauvegarde
Lyon, 69337, France
Service de Maladies infectieuses et tropicales, Hôpital Hôtel Dieu, CHU Nantes
Nantes, 44093, France
Service d'Infectiologie, Hôpital de l'Archet, CHU de Nice
Nice, 06200, France
Service des Maladies infectieuses, CH de Niort
Niort, 79021, France
Service des Maladies Infectieuses et Tropicales, Hôpital Carémeau, CHU de Nîmes
Nîmes, 30029, France
Service de Maladies infectieuses et tropicales, Hôpital de la Source, CHR Orléans
Orléans, 45100, France
APHP St Antoine
Paris, 75011, France
Service de Microbiologie, Hôpital Européen Georges Pompidou, APHP
Paris, 75015, France
Service de Maladies infectieuses et tropicales, Hôpital Necker, APHP
Paris, 75018, France
Service de Maladies infectieuses, parasitaires et tropicales, Hôpital Bichat, APHP
Paris, 75018, France
Institut Mutualiste Montsouris - Service de médecine interne
Paris, 75674, France
CH PAU - Service de Médecine interne et Maladies infectieuses
Pau, 64000, France
Service de Médecine interne, maladies infectieuses et tropicales, CHU de Poitiers
Poitiers, 86021, France
Infectiologie, médecine interne et médecine des voyages, CH d'Annecy
Pringy, 74374, France
CH QUIMPER - Service d'infectiologie
Quimper, 29107, France
Service de Médecine interne, maladies infectieuses, immunologie clinique, Hôpital R. Debré, CHU de Reims
Reims, 51092, France
Service des maladies infectieuses et réanimation médicale, Hôpital Pontchaillou, CHU de Rennes
Rennes, 35033, France
Service des Maladies infectieuses et tropicales, Hôpital Charles Nicolle, CHU de Rouen
Rouen, 76031, France
CHU St Etienne - Service des maladies infectieuses et tropicales
Saint-Priest-en-Jarez, 42270, France
Service des maladies respiratoires et infectieuses, CH de St Malo
St-Malo, 35403, France
Service des Maladies infectieuses et tropicales, Hôpital de Purpan, CHU de Toulouse
Toulouse, 31059, France
CHU Toulouse (Rangueil) Service de Cardiologie
Toulouse, 31400, France
Service Universitaire des Maladies Infectieuses et du voyageur, CH de Tourcoing
Tourcoing, 59208, France
Service de Médecine interne et maladies infectieuses, Hôpital Bretonneau, CHU de Tours
Tours, 37044, France
Service de Maladies infectieuses et tropicales, Hôpitaux de Brabois, CHU de Nancy
Vandœuvre-lès-Nancy, 54511, France
Consultation de Médecine Interne, maladies infectieuses et tropicales, CH intercommunal de Villeneuve St Georges
Villeneuve-Saint-Georges, 94190, France
Médipôle Lyon Villeurbanne
Villeurbanne, 69625, France
Related Publications (1)
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.
PMID: 32665381DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louis BERNARD, MD,PHD
CHRU TOURS
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2016
First Posted
March 8, 2016
Study Start
February 29, 2016
Primary Completion
August 15, 2024
Study Completion
December 4, 2024
Last Updated
February 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After publication of the main manuscript
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/