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Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus

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ClinicalTrials.gov Identifier: NCT02701595
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

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 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.


Condition or disease Intervention/treatment Phase
Infective Endocarditis Drug: Amoxicillin Procedure: Conventional IV treatment of streptococci/enterococci IE following European guidelines 2015 including amoxicillin, gentamicin, amicillin, vancomycin, penicillin G, ceftriaxone, netilmicin Phase 3

Detailed Description:

The RODEO 2 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 Streptococcus-Enterococcus IE who have received at least 10 days of IV antibiotic treatment with or without valvular surgery, a switch to an oral combination of amoxicillin 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus (Relais Oral Dans le Traitement Des Endocardites à Streptocoques Multi-sensibles)
Study Start Date : March 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis

Arm Intervention/treatment
Experimental: Oral switch treatment
Oral switch to amoxicillin
Drug: Amoxicillin
amoxicillin 1500 mg x3/day (for patients ≤70kg) or 2000 mg x3/day (for patients >70kg)

Active Comparator: Conventional IV treatment according to european guidelines
Conventional IV treatment of streptococci/enterococci IE (European guidelines 2015)
Procedure: Conventional IV treatment of streptococci/enterococci IE following European guidelines 2015 including amoxicillin, gentamicin, amicillin, vancomycin, penicillin G, ceftriaxone, netilmicin
Conventional IV treatment of streptococci/enterococci IE following European guidelines 2015 including amoxicillin, gentamicin, amicillin, vancomycin, penicillin G, ceftriaxone, netilmicin




Primary Outcome Measures :
  1. Treatment failure [ Time Frame: up to 6 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).


Secondary Outcome Measures :
  1. Death from all-cause [ Time Frame: up to 6 months after the end of antibiotic treatment ]
    death from all-causes

  2. number of symptomatic embolic events [ Time Frame: up to 6 months after the end of antibiotic treatment ]
    secondary osteo-articular, splenic or brain localization

  3. unplanned valvular surgery [ Time Frame: up to 6 months after the end of antibiotic treatment ]
    unplanned valvular surgery

  4. relapse of positive blood cultures [ Time Frame: up to 6 months after the end of antibiotic treatment ]
    relapse of positive blood cultures with the primary pathogen

  5. microbiological relapse with a different pathogen from the primary pathogen [ Time Frame: up to 6 months after the end of antibiotic treatment] ]
    Relapse of positive blood cultures with a different pathogen within 3 months after the end of antibiotic therapy

  6. Echocardiography [ Time Frame: up to 6 months after the end of antibiotic treatment ]
    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

  7. Catheter related adverse events [ Time Frame: up to 6 months after the end of antibiotic treatment ]
    Catheter-related AE: infectious (e.g. catheter-related bacteraemia) or non-infectious catheter-related complications (e.g. extravasation)

  8. other healthcare-acquired infections [ Time Frame: up to 6 months after the end of antibiotic treatment ]
    other healthcare-acquired infections, including urinary tract infections, pneumonia, surgical site infection, Clostridium difficile infections

  9. Number of participants with an antibiotic modification [ Time Frame: up to the end of antibiotic treatment ]
    All change regarding antibiotic treatment administered will be recorded (drug, dose or duration)

  10. Quality of life [ Time Frame: up to 6 months after the end of antibiotic treatment ]
    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)

  11. numer of participants with a switch back from oral to IV antibiotic treatment [ Time Frame: up to the end of antibiotic treatment ]
    For experimental group only . An assessment of the need for a return to parenteral antibiotic in the experimental group.

  12. Compliance with oral antibiotic treatment [ Time Frame: up to 4 weeks after randomisation ]

    For experimental group only. The assessment of compliance with oral antibiotic treatment will be carried out at each visit during the treatment period though a "patient book" which will permit to note take/omissions of treatment; and though the return of the treatments to the pharmacy of the investigational site.

    Calculation of the duration and cumulative dose of antibiotic treatment actually received will be performed, and compared to the regimen prescribed.


  13. Cost per patient [ Time Frame: up to 6 months after the end of antibiotic treatment ]
    Analysis using data from three centers (Tours, Rennes, Nancy) to compare both strategy (oral switch vs. pan-IV) for the cost per patient

  14. Budget impact analysis (BIA) [ Time Frame: up to 6 months after the end of antibiotic treatment ]
    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.

  15. Utility score and incremental cost-utility ratio (ICUR) [ Time Frame: up to 6 months after the end of antibiotic treatment ]
    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

  16. Length of hospital stay [ Time Frame: up to 6 months after the end of antibiotic treatment ]
    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

  17. Residual concentration of antibiotics [ Time Frame: 7 days ]
    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).

  18. Biological collection for further analysis on endocarditis [ Time Frame: up to 6 months after the end of antibiotic treatment ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≤ 0.125 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

Exclusion Criteria:

  • body mass index <15 kg/m² or > 40 kg/m²
  • glomerular filtration rate < 60 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701595


Contacts
Contact: Louis BERNARD, MD, PHD L.BERNARD@chu-tours.fr
Contact: Aurélie DARMAILLACQ 02.47.47.46.38 a.darmaillacq@chu-tours.fr

Locations
France
Service des maladies infectieuses, Centre Hospitalier du Pays d'Aix Not yet recruiting
Aix en Provence, France, 13616
Contact: Laurence MAULIN, Dr    04 42 33 90 13    lmaulin@ch-aix.fr   
Principal Investigator: Laurence MAULIN         
Service de court séjour gériatrique - EMG, Centre hospitalier d'Alès Not yet recruiting
Alès, France, 30103
Contact: Thibaut FRAISSE, Dr    04 66 78 31 56    dr.fraisse@ch-ales.fr   
Principal Investigator: Thibaut FRAISSE         
Service de Pathologies infectieuses et tropicales, Hôpital Nord, CHU d'Amiens Recruiting
Amiens, France, 80054
Contact: Jean-Phillipe LANOIX, Dr    03 22 66 88 13    lanoix.jean-philippe@chu-amiens.fr   
Principal Investigator: Jean-Phillipe LANOIX         
Service des Maladies infectieuses et Tropicales, Hôpital Jean Minjoz, CHU de Besançon Recruiting
Besançon, France, 25030
Contact: Catherine CHIROUZE, Pr    03 22 66 88 13    cchirouze@chu-besancon.fr   
Principal Investigator: Catherine CHIROUZE         
Service de maladies infectieuses et tropicales, Hôpital Avicenne, APHP Not yet recruiting
Bobigny, France, 93009
Contact: Frédéric MECHAI, Dr    01 48 95 78 13    frederic.mechai@avc.aphp.fr   
Principal Investigator: Frédéric MECHAI         
Service de Réanimation médicale, Hôpital St André, CHU de Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Fabrice CAMOU, Dr    05 56 79 58 30    fabrice.camou@chu-bordeaux.fr   
Principal Investigator: Fabrice CAMOU         
Service de médecine interne, Hôpital Ambroise Paré, APHP Not yet recruiting
Boulogne Billancourt, France, 92104
Contact: Elisabeth ROUVEIX NORDON, Pr    01 49 09 56 45    elisabeth.rouveix@apr.aphp.fr   
Principal Investigator: Elisabeth ROUVEIX NORDON         
Service de Maladies infectieuses, Hôpital de la Cavale Blanche, CHU Brest Not yet recruiting
Brest, France, 29609
Contact: Séverine ANSART, Pr    02 98 34 71 91    severine.ansart@chu-brest.fr   
Service de Cardiologie, Hôpitall Louis Pradel, Hôpitaux Est, Hospices Civils de Lyon Not yet recruiting
Bron, France, 69677
Contact: François DELAHAYE, Pr    04 72 35 76 28    francois.delahaye@chu-lyon.fr   
Principal Investigator: François DELAHAYE         
Service Maladies Infectieuses et tropicales, Hôpital Côte de Nacre, CHU de Caen Recruiting
Caen, France, 14033
Contact: Renaud VERDON, Pr    02 31 06 47 14    verdon-r@chu-caen.fr   
Principal Investigator: Renaud VERDON         
Service de Maladies infectieuses et tropicales médecine interne, CH Métropole Savoie Not yet recruiting
Chambéry, France, 73011
Contact: Emmanuel FORESTIER, Dr    04 79 96 58 47    emmanuel.forestier@ch-metropole-savoie.fr   
Principal Investigator: Emmanuel FORESTIER         
Service des maladies infectieuses et tropicales, Hôpital G. Montpied, CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Magali VIDAL, Dr    04 73 75 44 05    mvidal@chu-clermontferrand.fr   
Principal Investigator: Magali VIDAL         
Département d'infectiologie, Complexe Bocage, Hôpital d'enfants, CHU de Dijon Not yet recruiting
Dijon, France, 21079
Contact: Lionel PIROTH, Pr    03 80 29 36 31    lionel.piroth@chu-dijon.fr   
Principal Investigator: Lionel PIROTH         
Service de Médecine interne polyvalente et neurologique CH de Douai Not yet recruiting
Douai, France, 59507
Contact: Xavier LEMAIRE, Dr    03 27 94 74 50    xljhe@yahoo.fr   
Principal Investigator: Xavier LEMAIRE         
Service de médecine aigue spécifique, Hôpital Raymond Poincaré, APHP Recruiting
Garches, France, 92380
Contact: Aurélien DINH, Dr    01 47 10 44 32    aurelien.dinh@aphp.fr   
Principal Investigator: Aurélien DINH         
Service de médecine post-urgence, infectiologie, Site de la Roche sur Yon, CHD Vendée Not yet recruiting
La Roche sur Yon, France, 85025
Contact: Thomas GUIMARD, Dr    02 51 44 63 85    thomas.guimard@chd-vendee.fr   
Principal Investigator: Thomas GUIMARD         
Service de Médecine infectieuse, Hôpital Nord Michallon, CHU de Grenoble Recruiting
La Tronche, France, 38700
Contact: Olivier EPAULARD, Pr    04 76 76 52 91    OEpaulard@chu-grenoble.fr   
Principal Investigator: Olivier EPAULARD         
Service de Maladies infectieuses et tropicales, et pathologie VIH, Hôpital A Mignot, CH de Versailles Not yet recruiting
Le Chesnay, France, 78150
Contact: Alix GREDER-BELAN    01 39 63 80 10    agreder@ch-versailles.fr   
Principal Investigator: Alix GREDER-BELAN         
Service des Maladies infectieuses et tropicales, CH Le Mans Recruiting
Le Mans, France, 72037
Contact: Hikombo HITOTO    02 43 43 26 14    hhitoto@ch-lemans.fr   
Principal Investigator: Hikombo HITOTO         
Unité médicale d'infectiologie, Hôpital Huriez, CHU de Lille Not yet recruiting
Lille, France, 59037
Contact: Karine FAURE, Pr    03 20 44 57 43    karine.faure@chru-lille.fr   
Principal Investigator: Karine FAURE         
Service de Maladies Infectieuses et tropicales, Hôpital Dupuytren, CHU de Limoges Not yet recruiting
Limoges, France, 87042
Contact: Hélène DUROX, Dr    05 55 05 66 44    helene.durox@chu-limoges.fr   
Principal Investigator: Hélène DUROX         
Clinique de la sauvegarde Not yet recruiting
Lyon, France, 69337
Contact: Franck SIBELLAS, Dr    04 72 20 28 00    fsibellas@capio.fr   
Principal Investigator: Franck SIBELLAS         
Service de Maladies infectieuses, Hôpital Gui de CHauliac, CHU de Montpellier Not yet recruiting
Montpellier, France, 34295
Contact: Vincent Le Moing, Pr    04 67 33 77 14    v-le_moing@chu-montpellier.fr   
Principal Investigator: Vincent Le Moing         
Service de Maladies infectieuses et tropicales, Hôpital Hôtel Dieu, CHU Nantes Recruiting
Nantes, France, 44093
Contact: David BOUTOILLE, Pr    02 40 08 33 55    David.Boutoille@chu-nantes.fr   
Principal Investigator: David BOUTOILLE         
Service d'Infectiologie, Hôpital de l'Archet, CHU de Nice Recruiting
Nice, France, 06200
Contact: Elisa DEMONCHY, Dr    04 92 03 54 61    demonchy.e@chu-nice.fr   
Principal Investigator: Elisa DEMONCHY         
Service des Maladies infectieuses, CH de Niort Recruiting
Niort, France, 79021
Contact: Simon SUNDER, Dr    05 49 78 30 75    simon.sunder@ch-niort.fr   
Principal Investigator: Simon SUNDER         
Service des Maladies Infectieuses et Tropicales, Hôpital Carémeau, CHU de Nîmes Recruiting
Nîmes, France, 30029
Contact: Catherine LECHICHE, Dr    04 66 68 41 49    catherine.lechiche@chu-nimes.fr   
Principal Investigator: Catherine LECHICHE         
Service de Maladies infectieuses et tropicales, Hôpital de la Source, CHR Orléans Recruiting
Orléans, France, 45100
Contact: Laurent HOCQUELOUX, Dr    02 38 22 95 88    laurent.hocqueloux@chr-orleans.fr   
Principal Investigator: Laurent HOCQUELOUX         
Service de Microbiologie, Hôpital Européen Georges Pompidou, APHP Recruiting
Paris, France, 75015
Contact: Jean-Luc MAINARDI, Pr    01 56 09 22 54    jean-luc.mainardi@egp.aphp.fr   
Principal Investigator: Jean-Luc MAINARDI         
Service de maladies infectieuses et tropicales, Hôpital Necker, APHP Recruiting
Paris, France, 75018
Contact: Caroline CHARLIER, Dr    01 44 49 52 62    caroline.charlier@nck.aphp.fr   
Principal Investigator: Caroline CHARLIER         
Service de maladies infectieuses, parasitaires et tropicales, Hôpital Bichat, APHP Not yet recruiting
Paris, France, 75018
Contact: Xavier Marie DUVAL, Pr    01 40 25 88 92    xavier.duval@bch.aphp.fr   
Principal Investigator: Xavier Marie DUVAL         
Service des Maladies infectieuses et tropicales, CH de Perpignan Not yet recruiting
Perpignan, France, 66000
Contact: Aurélia EDEN, Dr    05 49 78 30 75    aurelia.eden@ch-perpignan.fr   
Principal Investigator: Aurélia EDEN         
Service de Médecine interne, maladies infectieuses et tropicales, CHU de Poitiers Recruiting
Poitiers, France, 86021
Contact: Guillaume BERAUD, Dr    05 49 44 40 04    beraudguillaume@gmail.com   
Principal Investigator: Guillaume BERAUD         
Infectiologie, médecine interne et médecine des voyages, CH d'Annecy Recruiting
Pringy, France, 74374
Contact: Jean-Pierre BRU, Dr    04 50 63 66 02    jpbru@ch-annecygenevois.fr   
Principal Investigator: Jean-Pierre BRU         
Service de Médecine interne, maladies infectieuses, immunologie clinique, Hôpital R. Debré, CHU de Reims Recruiting
Reims, France, 51092
Contact: Firouzé BANI SADR, Pr    03 26 78 71 89    fbanisadr@chu-reims.fr   
Principal Investigator: Firouzé BANI SADR         
Service des maladies infectieuses et réanimation médicale, Hôpital Pontchaillou, CHU de Rennes Not yet recruiting
Rennes, France, 35033
Contact: Pierre TATTEVIN, Pr    02 99 28 95 64    pierre.tattevin@chu-rennes.fr   
Principal Investigator: Pierre TATTEVIN         
Service des Maladies infectieuses et tropicales, Hôpital Charles Nicolle, CHU de Rouen Not yet recruiting
Rouen, France, 76031
Contact: Claire CHAPUZET, Dr    02 32 88 87 39    claire.chapuzet@chu-rouen.fr   
Principal Investigator: Claire CHAPUZET         
Service des maladies respiratoires et infectieuses, CH de St Malo Recruiting
Saint Malo, France, 35403
Contact: Mathieu DUPONT, Dr    02 99 21 21 70    m.dupont@ch-stmalo.fr   
Principal Investigator: Mathieu DUPONT         
Service des Maladie infectieuses et tropicales, Hôpital d'instruction des armées Bégin Not yet recruiting
Saint-Mande, France, 94163
Contact: Christophe RAPP, Pr    01 43 98 48 37    Rappchristophe5@gmail.com   
Principal Investigator: Christophe RAPP         
Service des Maladies infectieuses et tropicales, Hôpital de Purpan, CHU de Toulouse Not yet recruiting
Toulouse, France, 31059
Contact: Lydie PORTE, Dr    05 61 77 91 17    porte.l@chu-toulouse.fr   
Principal Investigator: Lydie PORTE         
Service Universitaire des Maladies Infectieuses et du voyageur, CH de Tourcoing Not yet recruiting
Tourcoing, France, 59208
Contact: Eric SENNEVILLE, Pr    03 20 69 48 48    esenneville@ch-tourcoing.fr   
Principal Investigator: Eric SENNEVILLE         
Service de Médecine interne et maladies infectieuses, Hôpital Bretonneau, CHU de Tours Recruiting
Tours, France, 37044
Contact: Louis BERNARD, Pr    02 18 37 06 44    L.BERNARD@chu-tours.fr   
Principal Investigator: Louis BERNARD         
Service de Maladies infectieuses et tropicales, Hôpitaux de Brabois, CHU de Nancy Recruiting
Vandoeuvre les Nancy, France, 54511
Contact: François GOEHRINGER, Dr    03 83 15 40 98    f.goehringer@chu-nancy.fr   
Principal Investigator: François GOEHRINGER         
Consultation de Médecine Interne, maladies infectieuses et tropicales, CH intercommunal de Villeneuve St Georges Not yet recruiting
Villeneuve St Georges, France, 94190
Contact: Olivier PATEY, Dr    01 43 86 20 81    Olivier.patey@chiv.fr   
Principal Investigator: Olivier PATEY         
Clinique du Tonkin Not yet recruiting
Villeurbanne, France, 69626
Contact: Bertrand ISSARTEL, Dr    08 26 10 12 01    bertrand.issartel@vaccination-lyon.com   
Principal Investigator: Bertrand ISSARTEL         
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Louis BERNARD, MD,PHD CHRU TOURS

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02701595     History of Changes
Other Study ID Numbers: RODEO 2
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Bacterial
Bacterial Infections
Cardiovascular Infections
Infection
Anti-Bacterial Agents
Heart Diseases
Cardiovascular Diseases
Amoxicillin
Vancomycin
Gentamicins
Ceftriaxone
Penicillins
Penicillin G
Penicillin G Benzathine
Penicillin G Procaine
Netilmicin
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action