Informations générales (source: ClinicalTrials.gov)
Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus (Relais Oral Dans le Traitement Des Endocardites à Streptocoques Multi-sensibles)
Interventional
Phase 3
University Hospital, Tours (Voir sur ClinicalTrials)
février 2016
septembre 2024
07 septembre 2024
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
Streptococcus-Enterococcus 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 2 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 amoxicillin 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 streptococci, and enterococci IE with a benefit regarding costs.
The RODEO 2 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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Avicenne | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Bicêtre | ESCAUT Lelia, Dr | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Bichat | Xavier Marie DUVAL, Pr | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Europeen Georges Pompidou | Jean-Luc MAINARDI, Pr | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | LEPEULE Raphael, Dr | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Necker-Enfants Malades | Caroline CHARLIER, Dr | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Saint Antoine | KRAUSE Jessica, Dr | Contact (sur clinicalTrials) | |||
| CH DE VERSAILLES SITE ANDRE MIGNOT | Contact (sur clinicalTrials) | ||||
| IFSI DU CHI DE VILLENEUVE-ST-GEORGES | Olivier PATEY, Dr | Contact (sur clinicalTrials) | |||
| INSTITUT MUTUALISTE MONTSOURIS | RICHAUD Clémence, Dr | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH PAU - Service de Médecine interne et Maladies infectieuses - 64000 - Pau - France | DUMONDIN Gilles, Dr | Contact (sur clinicalTrials) | |||
| CH QUIMPER - Service d'infectiologie - 29107 - Quimper - France | Lydie KHATCHATOURIAN, Dr | Contact (sur clinicalTrials) | |||
| CHU St Etienne - Service des maladies infectieuses et tropicales - 42270 - Saint-Priest-en-Jarez - France | Elisabeth BOTELHO NEVERS, Dr | Contact (sur clinicalTrials) | |||
| Clinique de la sauvegarde - 69337 - Lyon - France | Franck SIBELLAS, Dr | Contact (sur clinicalTrials) | |||
| Département d'infectiologie, Complexe Bocage, Hôpital d'enfants, CHU de Dijon - 21079 - Dijon - France | Lionel PIROTH, Pr | Contact (sur clinicalTrials) | |||
| Service de Cardiologie, Hôpitall Louis Pradel, Hôpitaux Est, Hospices Civils de Lyon - 69677 - Bron - France | François DELAHAYE, Pr | Contact (sur clinicalTrials) | |||
| Service de Maladies infectieuses et tropicales médecine interne, CH Métropole Savoie - 73011 - Chambéry - France | Emmanuel FORESTIER, Dr | Contact (sur clinicalTrials) | |||
| Service de Maladies infectieuses et tropicales, Hôpital de la Source, CHR Orléans - 45100 - Orléans - France | Laurent HOCQUELOUX, Dr | Contact (sur clinicalTrials) | |||
| Service de Maladies Infectieuses et tropicales, Hôpital Dupuytren, CHU de Limoges - 87042 - Limoges - France | Contact (sur clinicalTrials) | ||||
| Service de Maladies infectieuses et tropicales, Hôpital Hôtel Dieu, CHU Nantes - 44093 - Nantes - France | David BOUTOILLE, Pr | Contact (sur clinicalTrials) | |||
| Service de Maladies infectieuses et tropicales, Hôpitaux de Brabois, CHU de Nancy - 54511 - Vandoeuvre les Nancy - France | François GOEHRINGER, Dr | Contact (sur clinicalTrials) | |||
| Service de Maladies infectieuses, Hôpital de la Cavale Blanche, CHU Brest - 29609 - Brest - France | Contact (sur clinicalTrials) | ||||
| Service de Maladies infectieuses, Hôpital Gui de CHauliac, CHU de Montpellier - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Service de Médecine infectieuse, Hôpital Nord Michallon, CHU de Grenoble - 38700 - La Tronche - France | Olivier EPAULARD, Pr | Contact (sur clinicalTrials) | |||
| Service de Médecine interne et maladies infectieuses, Hôpital Bretonneau, CHU de Tours - 37044 - Tours - France | Louis BERNARD, Pr | Contact (sur clinicalTrials) | |||
| Service de Médecine interne polyvalente et neurologique CH de Douai - 59507 - Douai - France | Xavier LEMAIRE, Dr | Contact (sur clinicalTrials) | |||
| Service de Médecine interne, maladies infectieuses et tropicales, CHU de Poitiers - 86021 - Poitiers - France | Guillaume BERAUD, Dr | Contact (sur clinicalTrials) | |||
| Service de Médecine interne, maladies infectieuses, immunologie clinique, Hôpital R. Debré, CHU de Reims - 51092 - Reims - France | Firouzé BANI SADR, Pr | Contact (sur clinicalTrials) | |||
| Service de médecine post-urgence, infectiologie, Site de la Roche sur Yon, CHD Vendée - 85025 - La Roche sur Yon - France | Thomas GUIMARD, Dr | Contact (sur clinicalTrials) | |||
| Service de Réanimation médicale, Hôpital St André, CHU de Bordeaux - 33000 - Bordeaux - France | Fabrice CAMOU, Dr | Contact (sur clinicalTrials) | |||
| Service des Maladie infectieuses et tropicales, Hôpital d'instruction des armées Bégin - 94163 - Saint-Mande - France | Contact (sur clinicalTrials) | ||||
| Service des Maladies infectieuses et tropicales, CH de Perpignan - 66000 - Perpignan - France | Contact (sur clinicalTrials) | ||||
| Service des Maladies Infectieuses et Tropicales, Hôpital Carémeau, CHU de Nîmes - 30029 - Nîmes - France | Catherine LECHICHE, Dr | Contact (sur clinicalTrials) | |||
| Service des Maladies infectieuses et tropicales, Hôpital Charles Nicolle, CHU de Rouen - 76031 - Rouen - France | Claire CHAPUZET, Dr | Contact (sur clinicalTrials) | |||
| Service des Maladies infectieuses et tropicales, Hôpital de Purpan, CHU de Toulouse - 31059 - Toulouse - France | Lydie PORTE, Dr | Contact (sur clinicalTrials) | |||
| Service des maladies infectieuses et tropicales, Hôpital G. Montpied, CHU de Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Magali VIDAL, Dr | Contact (sur clinicalTrials) | |||
| Service des maladies infectieuses, Centre Hospitalier du Pays d'Aix - 13616 - Aix en Provence - France | Contact (sur clinicalTrials) | ||||
| Service des maladies respiratoires et infectieuses, CH de St Malo - 35403 - Saint Malo - France | Mathieu DUPONT, Dr | Contact (sur clinicalTrials) | |||
| Service d'Infectiologie, Hôpital de l'Archet, CHU de Nice - 06200 - Nice - France | Elisa DEMONCHY, Dr | Contact (sur clinicalTrials) | |||
| Service Maladies Infectieuses et tropicales, Hôpital Côte de Nacre, CHU de Caen - 14033 - Caen - France | Renaud VERDON, Pr | Contact (sur clinicalTrials) | |||
| Unité médicale d'infectiologie, Hôpital Huriez, CHU de Lille - 59037 - Lille - France | Karine FAURE, Pr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU ANGERS - Service des maladies infectieuses et tropicales - 49100 - Angers - France | DUBEE Vincent, Dr | Contact (sur clinicalTrials) | |||
| CHU Toulouse (Rangueil) Service de Cardiologie - Toulouse - France | PORTE Lydie, Dr | Contact (sur clinicalTrials) | |||
| Infectiologie, médecine interne et médecine des voyages, CH d'Annecy - 74374 - Pringy - France | Virginie VITRAT, Dr | Contact (sur clinicalTrials) | |||
| Medipôle Lyon-Villeurbanne - 69625 - Villeurbanne - France | Bertrand ISSARTEL, Dr | Contact (sur clinicalTrials) | |||
| Service de court séjour gériatrique - EMG, Centre hospitalier d'Alès - 30103 - Alès - France | Contact (sur clinicalTrials) | ||||
| Service de médecine aigue spécifique, Hôpital Raymond Poincaré, APHP - 92380 - Garches - France | Aurélien DINH, Dr | Contact (sur clinicalTrials) | |||
| Service de médecine interne, Hôpital Ambroise Paré, APHP - 92104 - Boulogne Billancourt - France | Elisabeth ROUVEIX NORDON, Pr | Contact (sur clinicalTrials) | |||
| Service de Pathologies infectieuses et tropicales, Hôpital Nord, CHU d'Amiens - 80054 - Amiens - France | Jean-Phillipe LANOIX, Dr | Contact (sur clinicalTrials) | |||
| Service des maladies infectieuses et réanimation médicale, Hôpital Pontchaillou, CHU de Rennes - 35033 - Rennes - France | Pierre TATTEVIN, Pr | Contact (sur clinicalTrials) | |||
| Service des Maladies infectieuses et tropicales, CH Le Mans - 72037 - Le Mans - France | Hikombo HITOTO | Contact (sur clinicalTrials) | |||
| Service des Maladies infectieuses et Tropicales, Hôpital Jean Minjoz, CHU de Besançon - 25030 - Besançon - France | Catherine CHIROUZE, Pr | Contact (sur clinicalTrials) | |||
| Service des Maladies infectieuses, CH de Niort - 79021 - Niort - France | Simon SUNDER, Dr | Contact (sur clinicalTrials) | |||
| Service Universitaire des Maladies Infectieuses et du voyageur, CH de Tourcoing - 59208 - Tourcoing - France | Eric SENNEVILLE, Pr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Left-sided IE (Defined according to Duke criteria) on native or prosthetic valve
- due to one isolate of Streptococcus/Enterococcus sp. susceptible to amoxicillin (MCI
≤ 0.5 mg/l)
- 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
- Left-sided IE (Defined according to Duke criteria) on native or prosthetic valve
- due to one isolate of Streptococcus/Enterococcus sp. susceptible to amoxicillin (MCI
≤ 0.5 mg/l)
- 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
- body mass index <15 kg/m² or > 40 kg/m²
- glomerular filtration rate < 30 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
- for 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. amoxicillin) - including anticipated non-manageable drug interactions, and
allergy.