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

Primary Purpose

Infective Endocarditis

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Levofloxacin
Rifampicin
Conventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicine
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infective Endocarditis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Service des Maladies infectieuses, Centre Hospitalier du Pays d'Aix
  • Service de court séjour gériatrique - EMG, Centre hospitalier d'Alès
  • Service de Pathologies infectieuses et tropicales, Hôpital Nord, CHU d'AmiensRecruiting
  • CHU ANGERS - Service des maladies infectieuses et tropicalesRecruiting
  • Service des Maladies infectieuses et Tropicales, Hôpital Jean Minjoz, CHU de BesançonRecruiting
  • Service de Maladies infectieuses et tropicales, Hôpital Avicenne, APHP
  • Service de Réanimation médicale, Hôpital St André, CHU de BordeauxRecruiting
  • Service de Médecine interne, Hôpital Ambroise Paré, APHPRecruiting
  • Service de Maladies infectieuses, Hôpital de la Cavale Blanche
  • Service de Cardiologie, Hôpitall Louis Pradel, Hôpitaux Est, Hospices Civils de LyonRecruiting
  • Service Maladies Infectieuses et tropicales, Hôpital Côte de Nacre, CHU de CaenRecruiting
  • Service de Maladies infectieuses et tropicales, médecine interne, CH de ChambéryRecruiting
  • Service des maladies infectieuses et tropicales, Hôpital G. Montpied, CHU de Clermont-FerrandRecruiting
  • APHP Henri-Mondor - Service des maladies infectieuses et tropicales
  • Département d'infectiologie, Complexe Bocage, Hôpital d'enfants, CHU de DijonRecruiting
  • Service de Médecine interne polyvalente et neurologique CH de DouaiRecruiting
  • Service de Médecine aigue spécifique, Hôpital Raymond Poincaré, APHPRecruiting
  • Service de Médecine post-urgence, infectiologie, Site de la Roche sur Yon, CHD VendéeRecruiting
  • Service de Médecine infectieuse, Hôpital Nord Michallon, CHU de GrenobleRecruiting
  • Service de Maladies infectieuses et tropicales, et pathologie VIH
  • APHP BICETRE - Service des maladies infectieuses et tropicales
  • Service des Maladies infectieuses et tropicales, CH Le MansRecruiting
  • Unité médicale d'infectiologie, Hôpital Huriez, CHU de LilleRecruiting
  • Service de Maladies Infectieuses et tropicales, Hôpital Dupuytren, CHU de Limoges
  • Clinique de la SauvegardeRecruiting
  • Service de Maladies infectieuses, Hôpital Gui de CHauliac, CHU de Montpellier
  • Service de Maladies infectieuses et tropicales, Hôpital Hôtel Dieu, CHU NantesRecruiting
  • Service d'Infectiologie, Hôpital de l'Archet, CHU de NiceRecruiting
  • Service des Maladies infectieuses, CH de NiortRecruiting
  • Service des Maladies Infectieuses et Tropicales, Hôpital Carémeau, CHU de NîmesRecruiting
  • Service de Maladies infectieuses et tropicales, Hôpital de la Source, CHR OrléansRecruiting
  • APHP St Antoine
  • Service de Microbiologie, Hôpital Européen Georges Pompidou, APHPRecruiting
  • Service de Maladies infectieuses et tropicales, Hôpital Necker, APHPRecruiting
  • Service de Maladies infectieuses, parasitaires et tropicales, Hôpital Bichat, APHPRecruiting
  • Institut Mutualiste Montsouris - Service de médecine interneRecruiting
  • CH PAU - Service de Médecine interne et Maladies infectieuses
  • Service des Maladies infectieuses et tropicales, CH de Perpignan
  • Service de Médecine interne, maladies infectieuses et tropicales, CHU de PoitiersRecruiting
  • Infectiologie, médecine interne et médecine des voyages, CH d'AnnecyRecruiting
  • CH QUIMPER - Service d'infectiologieRecruiting
  • Service de Médecine interne, maladies infectieuses, immunologie clinique, Hôpital R. Debré, CHU de ReimsRecruiting
  • Service des maladies infectieuses et réanimation médicale, Hôpital Pontchaillou, CHU de RennesRecruiting
  • Service des Maladies infectieuses et tropicales, Hôpital Charles Nicolle, CHU de RouenRecruiting
  • Service des maladies respiratoires et infectieuses, CH de St MaloRecruiting
  • Service des Maladie infectieuses et tropicales, Hôpital d'instruction des armées Bégin
  • CHU St Etienne - Service des maladies infectieuses et tropicalesRecruiting
  • Service des Maladies infectieuses et tropicales, Hôpital de Purpan, CHU de ToulouseRecruiting
  • CHU Toulouse (Rangueil) Service de Cardiologie
  • Service Universitaire des Maladies Infectieuses et du voyageur, CH de TourcoingRecruiting
  • Service de Médecine interne et maladies infectieuses, Hôpital Bretonneau, CHU de ToursRecruiting
  • Service de Maladies infectieuses et tropicales, Hôpitaux de Brabois, CHU de NancyRecruiting
  • Consultation de Médecine Interne, maladies infectieuses et tropicales, CH intercommunal de Villeneuve St GeorgesRecruiting
  • Médipôle Lyon VilleurbanneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral switch treatment

Conventional IV treatment according to european guidelines

Arm Description

Oral switch to the combination of levofloxacin and rifampicin

Conventional IV treatment of staphylococci IE (European guidelines 2015)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

death from all-cause
death from all-cause
number of symptomatic embolic events
secondary osteo-articular, splenic or brain localization
unplanned valvular surgery
unplanned valvular surgery
relapse of positive blood cultures
relapse of positive blood cultures with the primary pathogen
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
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
Catheter related adverse events
Catheter-related AE: infectious (e.g. catheter-related bacteraemia) or non-infectious catheter-related complications (e.g. extravasation).
other healthcare-acquired infections
other healthcare-acquired infections, including urinary tract infections, pneumonia, surgical site infection, Clostridium difficile infections
Number of participants with an antibiotic modification
All change regarding antibiotic treatment administered will be recorded (drug, dose or duration)
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)
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.
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.
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
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.
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.
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.
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).
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).

Full Information

First Posted
January 28, 2016
Last Updated
May 18, 2021
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT02701608
Brief Title
Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Staphylococcus
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 29, 2016 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infective Endocarditis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
324 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral switch treatment
Arm Type
Experimental
Arm Description
Oral switch to the combination of levofloxacin and rifampicin
Arm Title
Conventional IV treatment according to european guidelines
Arm Type
Active Comparator
Arm Description
Conventional IV treatment of staphylococci IE (European guidelines 2015)
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Other Intervention Name(s)
Fluoroquinolones
Intervention Description
levofloxacin 500 mg x1/day (for patients ≤70kg) or levofloxacin 750 mg x1/day (for patients >70kg)
Intervention Type
Drug
Intervention Name(s)
Rifampicin
Intervention Description
rifampicin 600mg x1/day (for patients ≤70kg) or rifampicin 900mg x1/day (for patients >70kg)
Intervention Type
Procedure
Intervention Name(s)
Conventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicine
Intervention Description
Conventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicine
Primary Outcome Measure Information:
Title
Treatment failure
Description
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).
Time Frame
up to 3 months after the end of antibiotic treatment
Secondary Outcome Measure Information:
Title
death from all-cause
Description
death from all-cause
Time Frame
up to 6 months after the end of antibiotic treatment
Title
number of symptomatic embolic events
Description
secondary osteo-articular, splenic or brain localization
Time Frame
up to 6 months after the end of antibiotic treatment
Title
unplanned valvular surgery
Description
unplanned valvular surgery
Time Frame
up to 6 months after the end of antibiotic treatment
Title
relapse of positive blood cultures
Description
relapse of positive blood cultures with the primary pathogen
Time Frame
up to 6 months after the end of antibiotic treatment
Title
microbiological relapse with a different pathogen from the primary pathogen
Description
Relapse of positive blood cultures with a different pathogen within 3 months after the end of antibiotic therapy
Time Frame
up to 6 months after the end of antibiotic treatment
Title
Echocardiography
Description
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
Time Frame
up to 6 months after the end of antibiotic treatment
Title
Catheter related adverse events
Description
Catheter-related AE: infectious (e.g. catheter-related bacteraemia) or non-infectious catheter-related complications (e.g. extravasation).
Time Frame
up to 6 months after the end of antibiotic treatment
Title
other healthcare-acquired infections
Description
other healthcare-acquired infections, including urinary tract infections, pneumonia, surgical site infection, Clostridium difficile infections
Time Frame
up to 6 months after the end of antibiotic treatment
Title
Number of participants with an antibiotic modification
Description
All change regarding antibiotic treatment administered will be recorded (drug, dose or duration)
Time Frame
up to the end of antibiotic treatment
Title
Quality of life
Description
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)
Time Frame
up to 6 months after the end of antibiotic treatment
Title
number of participants with a switch back from oral to IV antibiotic treatment
Description
For experimental group only . An assessment of the need for a return to parenteral antibiotic in the experimental group.
Time Frame
up to the end of antibiotic treatment
Title
Compliance with oral antibiotic treatment
Description
For experimental group only. The assessment of compliance with oral antibiotic treatment will be carried out at each visit during the treatment period.
Time Frame
up to 4 weeks after randomisation
Title
Cost per patient
Description
Analysis using data from three centers (Tours, Rennes, Nancy) to compare both strategy (oral switch vs. pan-IV) for the cost per patient
Time Frame
up to 6 months after the end of antibiotic treatment
Title
Budget impact analysis (BIA)
Description
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.
Time Frame
up to 6 months after the end of antibiotic treatment
Title
Utility score and incremental cost-utility ratio (ICUR)
Description
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.
Time Frame
up to 6 months after the end of antibiotic treatment
Title
Length of hospital stay
Description
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.
Time Frame
up to 6 months after the end of antibiotic treatment
Title
Residual concentration of antibiotics
Description
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).
Time Frame
7 days
Title
Biological collection for further analysis on endocarditis
Description
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).
Time Frame
up to 6 months after the end of antibiotic treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Louis BERNARD, MD, PHD
Email
L.BERNARD@chu-tours.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie MOUSSET
Phone
02.47.47.46.65
Email
e.mousset@chu-tours.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis BERNARD, MD,PHD
Organizational Affiliation
CHRU TOURS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service des Maladies infectieuses, Centre Hospitalier du Pays d'Aix
City
Aix en Provence
ZIP/Postal Code
13616
Country
France
Individual Site Status
Withdrawn
Facility Name
Service de court séjour gériatrique - EMG, Centre hospitalier d'Alès
City
Alès
ZIP/Postal Code
30103
Country
France
Individual Site Status
Withdrawn
Facility Name
Service de Pathologies infectieuses et tropicales, Hôpital Nord, CHU d'Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Phillipe LANOIX, Dr
Phone
03 22 66 88 13
Email
lanoix.jean-philippe@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Jean-Phillipe LANOIX
Facility Name
CHU ANGERS - Service des maladies infectieuses et tropicales
City
Angers
ZIP/Postal Code
49100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DUBEE Vincent, Dr
Phone
06 65 80 70 22
Email
vincent.dubee@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
DUBEE Vincent, Dr
Facility Name
Service des Maladies infectieuses et Tropicales, Hôpital Jean Minjoz, CHU de Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine CHIROUZE, Pr
Phone
03 22 66 88 13
Email
cchirouze@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Catherine CHIROUZE
Facility Name
Service de Maladies infectieuses et tropicales, Hôpital Avicenne, APHP
City
Bobigny
ZIP/Postal Code
93009
Country
France
Individual Site Status
Withdrawn
Facility Name
Service de Réanimation médicale, Hôpital St André, CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice CAMOU, Dr
Phone
05 56 79 58 30
Email
fabrice.camou@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Fabrice CAMOU
Facility Name
Service de Médecine interne, Hôpital Ambroise Paré, APHP
City
Boulogne Billancourt
ZIP/Postal Code
92104
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth ROUVEIX NORDON, Pr
Phone
01 49 09 56 45
Email
elisabeth.rouveix@apr.aphp.fr
First Name & Middle Initial & Last Name & Degree
Elisabeth ROUVEIX NORDON
Facility Name
Service de Maladies infectieuses, Hôpital de la Cavale Blanche
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Withdrawn
Facility Name
Service de Cardiologie, Hôpitall Louis Pradel, Hôpitaux Est, Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François DELAHAYE, Pr
Phone
04 72 35 76 28
Email
francois.delahaye@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
François DELAHAYE
Facility Name
Service Maladies Infectieuses et tropicales, Hôpital Côte de Nacre, CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renaud VERDON, Pr
Phone
02 31 06 47 14
Email
verdon-r@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Renaud VERDON
Facility Name
Service de Maladies infectieuses et tropicales, médecine interne, CH de Chambéry
City
Chambéry
ZIP/Postal Code
73011
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel FORESTIER, Dr
Phone
04 79 96 58 47
Email
emmanuel.forestier@ch-metropole-savoie.fr
First Name & Middle Initial & Last Name & Degree
Emmanuel FORESTIER
Facility Name
Service des maladies infectieuses et tropicales, Hôpital G. Montpied, CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magali VIDAL, Dr
Phone
04 73 75 44 05
Email
mvidal@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Magali VIDAL
Facility Name
APHP Henri-Mondor - Service des maladies infectieuses et tropicales
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LEPEULE Raphael, Dr
Phone
01 49 81 22 11
Email
raphael.lepeule@aphp.fr
First Name & Middle Initial & Last Name & Degree
LEPEULE Raphael, Dr
Facility Name
Département d'infectiologie, Complexe Bocage, Hôpital d'enfants, CHU de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel PIROTH, Pr
Phone
03 80 29 36 31
Email
lionel.piroth@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Lionel PIROTH
Facility Name
Service de Médecine interne polyvalente et neurologique CH de Douai
City
Douai
ZIP/Postal Code
59507
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier LEMAIRE
Phone
03 27 94 74 50
Email
xljhe@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Xavier LEMAIRE
Facility Name
Service de Médecine aigue spécifique, Hôpital Raymond Poincaré, APHP
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélien DINH, Dr
Phone
01 47 10 44 32
Email
aurelien.dinh@aphp.fr
First Name & Middle Initial & Last Name & Degree
Aurélien DINH
Facility Name
Service de Médecine post-urgence, infectiologie, Site de la Roche sur Yon, CHD Vendée
City
La Roche sur Yon
ZIP/Postal Code
85025
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas GUIMARD, Dr
Phone
02 51 44 63 85
Email
thomas.guimard@chd-vendee.fr
First Name & Middle Initial & Last Name & Degree
Thomas GUIMARD
Facility Name
Service de Médecine infectieuse, Hôpital Nord Michallon, CHU de Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier EPAULARD, Pr
Phone
04 76 76 52 91
Email
OEpaulard@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Olivier EPAULARD
Facility Name
Service de Maladies infectieuses et tropicales, et pathologie VIH
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Individual Site Status
Withdrawn
Facility Name
APHP BICETRE - Service des maladies infectieuses et tropicales
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Service des Maladies infectieuses et tropicales, CH Le Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hikombo HITOTO
Phone
02 43 43 26 14
Email
hhitoto@ch-lemans.fr
First Name & Middle Initial & Last Name & Degree
Hikombo HITOTO
Facility Name
Unité médicale d'infectiologie, Hôpital Huriez, CHU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karine FAURE, Pr
Phone
03 20 44 57 43
Email
karine.faure@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
Karine FAURE
Facility Name
Service de Maladies Infectieuses et tropicales, Hôpital Dupuytren, CHU de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Withdrawn
Facility Name
Clinique de la Sauvegarde
City
Lyon
ZIP/Postal Code
69337
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck SIBELLAS, Dr
Phone
04 72 20 28 00
Email
fsibellas@capio.fr
First Name & Middle Initial & Last Name & Degree
Franck SIBELLAS
Facility Name
Service de Maladies infectieuses, Hôpital Gui de CHauliac, CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Withdrawn
Facility Name
Service de Maladies infectieuses et tropicales, Hôpital Hôtel Dieu, CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David BOUTOILLE, Pr
Phone
02 40 08 33 55
Email
David.Boutoille@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
David BOUTOILLE
Facility Name
Service d'Infectiologie, Hôpital de l'Archet, CHU de Nice
City
Nice
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisa DEMONCHY, Dr
Phone
04 92 03 54 61
Email
demonchy.e@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Elisa DEMONCHY
Facility Name
Service des Maladies infectieuses, CH de Niort
City
Niort
ZIP/Postal Code
79021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon SUNDER, Dr
Phone
05 49 78 30 75
Email
simon.sunder@ch-niort.fr
First Name & Middle Initial & Last Name & Degree
Simon SUNDER
Facility Name
Service des Maladies Infectieuses et Tropicales, Hôpital Carémeau, CHU de Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine LECHICHE, Dr
Phone
04 66 68 41 49
Email
catherine.lechiche@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Catherine LECHICHE
Facility Name
Service de Maladies infectieuses et tropicales, Hôpital de la Source, CHR Orléans
City
Orléans
ZIP/Postal Code
45100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent HOCQUELOUX, Dr
Phone
02 38 22 95 88
Email
laurent.hocqueloux@chr-orleans.fr
First Name & Middle Initial & Last Name & Degree
Laurent HOCQUELOUX
Facility Name
APHP St Antoine
City
Paris
ZIP/Postal Code
75011
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KRAUSE Jessica, Dr
Email
Jessica.krause@aphp.fr
First Name & Middle Initial & Last Name & Degree
KRAUSE Jessica, Dr
Facility Name
Service de Microbiologie, Hôpital Européen Georges Pompidou, APHP
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Luc MAINARDI, Pr
Phone
01 56 09 22 54
Email
jean-luc.mainardi@egp.aphp.fr
First Name & Middle Initial & Last Name & Degree
Jean-Luc MAINARDI
Facility Name
Service de Maladies infectieuses et tropicales, Hôpital Necker, APHP
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline CHARLIER, Dr
Phone
01 44 49 52 62
Email
caroline.charlier@nck.aphp.fr
First Name & Middle Initial & Last Name & Degree
Caroline CHARLIER
Facility Name
Service de Maladies infectieuses, parasitaires et tropicales, Hôpital Bichat, APHP
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Marie DUVAL, Dr
Phone
01 40 25 88 92
Email
xavier.duval@bch.aphp.fr
First Name & Middle Initial & Last Name & Degree
Xavier Marie DUVAL
Facility Name
Institut Mutualiste Montsouris - Service de médecine interne
City
Paris
ZIP/Postal Code
75674
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RICHAUD Clémence, Dr
Phone
01 56 61 67 70
Email
Clemence.Richaud@imm.fr
First Name & Middle Initial & Last Name & Degree
RICHAUD Clémence, Dr
Facility Name
CH PAU - Service de Médecine interne et Maladies infectieuses
City
Pau
ZIP/Postal Code
64000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Service des Maladies infectieuses et tropicales, CH de Perpignan
City
Perpignan
ZIP/Postal Code
66000
Country
France
Individual Site Status
Withdrawn
Facility Name
Service de Médecine interne, maladies infectieuses et tropicales, CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume BERAUD, Dr
Phone
05 49 44 40 04
Email
beraudguillaume@gmail.com
First Name & Middle Initial & Last Name & Degree
Guillaume BERAUD
Facility Name
Infectiologie, médecine interne et médecine des voyages, CH d'Annecy
City
Pringy
ZIP/Postal Code
74374
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginie VITRAT, Dr
Phone
04 50 63 66 02
Email
vvitrat@ch-annecygenevois.fr
First Name & Middle Initial & Last Name & Degree
Virginie VITRAT
Facility Name
CH QUIMPER - Service d'infectiologie
City
Quimper
ZIP/Postal Code
29107
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lydie KHATCHATOURIAN, Dr
Phone
02 90 94 41 12
Email
l.khatchatourian@ch-cornouaille.fr
First Name & Middle Initial & Last Name & Degree
Lydie KHATCHATOURIAN, Dr
Facility Name
Service de Médecine interne, maladies infectieuses, immunologie clinique, Hôpital R. Debré, CHU de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Firouzé BANI SADR, Pr
Phone
03 26 78 71 89
Email
fbanisadr@chu-reims.fr
First Name & Middle Initial & Last Name & Degree
Firouzé BANI SADR
Facility Name
Service des maladies infectieuses et réanimation médicale, Hôpital Pontchaillou, CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre TATTEVIN, Pr
Phone
02 99 28 95 64
Email
pierre.tattevin@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Pierre TATTEVIN
Facility Name
Service des Maladies infectieuses et tropicales, Hôpital Charles Nicolle, CHU de Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire CHAPUZET, Dr
Phone
02 32 88 87 39
Email
claire.chapuzet@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Claire CHAPUZET
Facility Name
Service des maladies respiratoires et infectieuses, CH de St Malo
City
Saint Malo
ZIP/Postal Code
35403
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu DUPONT, Dr
Phone
02 99 21 21 70
Email
m.dupont@ch-stmalo.fr
First Name & Middle Initial & Last Name & Degree
Mathieu DUPONT
Facility Name
Service des Maladie infectieuses et tropicales, Hôpital d'instruction des armées Bégin
City
Saint-Mande
ZIP/Postal Code
94163
Country
France
Individual Site Status
Withdrawn
Facility Name
CHU St Etienne - Service des maladies infectieuses et tropicales
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth BOTELHO NEVERS, Dr
Phone
04 77 12 77 89
Email
elisabeth.botelho-nevers@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Elisabeth BOTELHO NEVERS, Dr
Facility Name
Service des Maladies infectieuses et tropicales, Hôpital de Purpan, CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lydie PORTE, Dr
Phone
05 61 77 91 17
Email
porte.l@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Lydie PORTE
Facility Name
CHU Toulouse (Rangueil) Service de Cardiologie
City
Toulouse
ZIP/Postal Code
31400
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PORTE Lydie, Dr
Email
porte.l@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
PORTE Lydie, Dr
Facility Name
Service Universitaire des Maladies Infectieuses et du voyageur, CH de Tourcoing
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric SENNEVILLE, Pr
Phone
03 20 69 48 48
Email
esenneville@ch-tourcoing.fr
First Name & Middle Initial & Last Name & Degree
Eric SENNEVILLE
Facility Name
Service de Médecine interne et maladies infectieuses, Hôpital Bretonneau, CHU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis BERNARD, Pr
Phone
02 18 37 06 44
Email
L.BERNARD@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Louis BERNARD
Facility Name
Service de Maladies infectieuses et tropicales, Hôpitaux de Brabois, CHU de Nancy
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François GOEHRINGER, Dr
Phone
03 83 15 40 98
Email
f.goehringer@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
François GOEHRINGER
Facility Name
Consultation de Médecine Interne, maladies infectieuses et tropicales, CH intercommunal de Villeneuve St Georges
City
Villeneuve St Georges
ZIP/Postal Code
94190
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier PATEY, Dr
Phone
01 43 86 20 81
Email
Olivier.patey@chiv.fr
First Name & Middle Initial & Last Name & Degree
Olivier PATEY
Facility Name
Médipôle Lyon Villeurbanne
City
Villeurbanne
ZIP/Postal Code
69625
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand ISSARTEL, Dr
Phone
08 26 10 12 01
Email
bertrand.issartel@vaccination-lyon.com
First Name & Middle Initial & Last Name & Degree
Bertrand ISSARTEL

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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/
IPD Sharing Time Frame
After publication of the main manuscript
Citations:
PubMed Identifier
32665381
Citation
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.
Results Reference
derived

Learn more about this trial

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

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