Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-04 @ 8:39 PM
Study NCT ID:
NCT02701595
Status:
UNKNOWN
Last Update Posted:
2021-05-19
First Post:
2016-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004696', 'term': 'Endocarditis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D005839', 'term': 'Gentamicins'}, {'id': 'D014640', 'term': 'Vancomycin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D002443', 'term': 'Ceftriaxone'}, {'id': 'D009428', 'term': 'Netilmicin'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002439', 'term': 'Cefotaxime'}, {'id': 'D002505', 'term': 'Cephacetrile'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D012853', 'term': 'Sisomicin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 324}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2016-01-28', 'studyFirstSubmitQcDate': '2016-03-02', 'lastUpdatePostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment failure', 'timeFrame': 'up to 6 months after the end of antibiotic treatment', '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).'}], 'secondaryOutcomes': [{'measure': 'Death from all-cause', 'timeFrame': 'up to 6 months after the end of antibiotic treatment', 'description': 'death from all-causes'}, {'measure': 'number of symptomatic embolic events', 'timeFrame': 'up to 6 months after the end of antibiotic treatment', 'description': 'secondary osteo-articular, splenic or brain localization'}, {'measure': 'unplanned valvular surgery', 'timeFrame': 'up to 6 months after the end of antibiotic treatment', 'description': 'unplanned valvular surgery'}, {'measure': 'relapse of positive blood cultures', 'timeFrame': 'up to 6 months after the end of antibiotic treatment', 'description': 'relapse of positive blood cultures with the primary pathogen'}, {'measure': 'microbiological relapse with a different pathogen from the primary pathogen', 'timeFrame': 'up to 6 months after the end of antibiotic treatment]', 'description': 'Relapse of positive blood cultures with a different pathogen within 3 months after the end of antibiotic therapy'}, {'measure': 'Echocardiography', 'timeFrame': 'up to 6 months after the end of antibiotic treatment', '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'}, {'measure': 'Catheter related adverse events', 'timeFrame': 'up to 6 months after the end of antibiotic treatment', 'description': 'Catheter-related AE: infectious (e.g. catheter-related bacteraemia) or non-infectious catheter-related complications (e.g. extravasation)'}, {'measure': 'other healthcare-acquired infections', 'timeFrame': 'up to 6 months after the end of antibiotic treatment', 'description': 'other healthcare-acquired infections, including urinary tract infections, pneumonia, surgical site infection, Clostridium difficile infections'}, {'measure': 'Number of participants with an antibiotic modification', 'timeFrame': 'up to the end of antibiotic treatment', 'description': 'All change regarding antibiotic treatment administered will be recorded (drug, dose or duration)'}, {'measure': 'Quality of life', 'timeFrame': 'up to 6 months after the end of antibiotic treatment', '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)"}, {'measure': 'numer of participants with a switch back from oral to IV antibiotic treatment', 'timeFrame': 'up to the end of antibiotic treatment', 'description': 'For experimental group only . An assessment of the need for a return to parenteral antibiotic in the experimental group.'}, {'measure': 'Compliance with oral antibiotic treatment', 'timeFrame': 'up to 4 weeks after randomisation', 'description': '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.\n\nCalculation of the duration and cumulative dose of antibiotic treatment actually received will be performed, and compared to the regimen prescribed.'}, {'measure': 'Cost per patient', 'timeFrame': 'up to 6 months after the end of antibiotic treatment', 'description': 'Analysis using data from three centers (Tours, Rennes, Nancy) to compare both strategy (oral switch vs. pan-IV) for the cost per patient'}, {'measure': 'Budget impact analysis (BIA)', 'timeFrame': 'up to 6 months after the end of antibiotic treatment', '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.'}, {'measure': 'Utility score and incremental cost-utility ratio (ICUR)', 'timeFrame': 'up to 6 months after the end of antibiotic treatment', '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'}, {'measure': 'Length of hospital stay', 'timeFrame': 'up to 6 months after the end of antibiotic treatment', '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'}, {'measure': 'Residual concentration of antibiotics', 'timeFrame': '7 days', '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).'}, {'measure': 'Biological collection for further analysis on endocarditis', 'timeFrame': 'up to 6 months after the end of antibiotic treatment', '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).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Infective Endocarditis']}, 'referencesModule': {'references': [{'pmid': '32665381', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': "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.\n\nA 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.\n\nThese 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.\n\nThere 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.\n\nThe RODEO 2 project is an unprecedented opportunity to bring back evidence-based medicine in the field of IE.\n\nMost 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.\n\nIt'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.\n\nThe 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.", 'detailedDescription': '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.\n\nNationwide, noninferiority, multicenter, randomized, controlled, open-label trials.\n\nRandomisation 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.\n\nRandomisation 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.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Left-sided IE (Defined according to Duke criteria) on native or prosthetic valve\n* due to one isolate of Streptococcus/Enterococcus sp. susceptible to amoxicillin (MCI ≤ 0.5 mg/l)\n* in an adult ≥18 year old\n* appropriate parenteral antibiotics treatment received for at least 10 days\n* in case of valvular surgery, appropriate parenteral antibiotics treatment received for at least 10 days after valvular surgery\n* 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\n* apyrexia (temperature \\< 38°C) at each time point during the last 48 hours (at least two measures/day) at the time of randomisation\n* blood cultures have been sterile for at least 5 days at the time of randomisation\n* informed, written consent obtained from patient\n* subject covered by or having the rights to French social security\n\nExclusion Criteria:\n\n* body mass index \\<15 kg/m² or \\> 40 kg/m²\n* glomerular filtration rate \\< 30 ml/min/1,73m²\n* patient unable or unwilling to take oral treatment (digestive intolerance, significant malabsorption) at the time of randomisation\n* expected difficulties regarding compliance with oral antibiotic treatment or follow-up (e.g. severe cognitive impairment, severe psychiatric disease...)\n* patient without entourage to support and watch him at discharge\n* valvular surgery planned within the next 6 months\n* 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\n* breast feeding or pregnant women, or women on childbearing age without effective contraception\n* expected duration of follow-up \\< 7 months at the time of randomisation (e.g. expected life expectancy \\< 7 months, patient living abroad...)\n* past medical history of IE in the last 3 months\n* other infection requiring parenteral antibiotic therapy\n* taking of an estrogen-progesterone treatment interacting with rifampicin\n* patient with contra-indication to oral antibiotics administered in the experimental arm (i.e. amoxicillin) - including anticipated non-manageable drug interactions, and allergy.'}, 'identificationModule': {'nctId': 'NCT02701595', 'briefTitle': 'Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus (Relais Oral Dans le Traitement Des Endocardites à Streptocoques Multi-sensibles)', 'orgStudyIdInfo': {'id': 'RODEO 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral switch treatment', 'description': 'Oral switch to amoxicillin', 'interventionNames': ['Drug: Amoxicillin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional IV treatment according to european guidelines', 'description': 'Conventional IV treatment of streptococci/enterococci IE (European guidelines 2015)', 'interventionNames': ['Procedure: Conventional IV treatment of streptococci/enterococci IE following European guidelines 2015 including amoxicillin, gentamicin, amicillin, vancomycin, penicillin G, ceftriaxone, netilmicin']}], 'interventions': [{'name': 'Amoxicillin', 'type': 'DRUG', 'description': 'amoxicillin 1500 mg x3/day (for patients ≤70kg) or 2000 mg x3/day (for patients \\>70kg)', 'armGroupLabels': ['Oral switch treatment']}, {'name': 'Conventional IV treatment of streptococci/enterococci IE following European guidelines 2015 including amoxicillin, gentamicin, amicillin, vancomycin, penicillin G, ceftriaxone, netilmicin', 'type': 'PROCEDURE', 'description': 'Conventional IV treatment of streptococci/enterococci IE following European guidelines 2015 including amoxicillin, gentamicin, amicillin, vancomycin, penicillin G, ceftriaxone, netilmicin', 'armGroupLabels': ['Conventional IV treatment according to european guidelines']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13616', 'city': 'Aix-en-Provence', 'status': 'WITHDRAWN', 'country': 'France', 'facility': "Service des maladies infectieuses, Centre Hospitalier du Pays d'Aix", 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '30103', 'city': 'Alès', 'status': 'WITHDRAWN', 'country': 'France', 'facility': "Service de court séjour gériatrique - EMG, Centre hospitalier d'Alès", 'geoPoint': {'lat': 44.12489, 'lon': 4.08082}}, {'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Phillipe LANOIX, Dr', 'role': 'CONTACT', 'email': 'lanoix.jean-philippe@chu-amiens.fr', 'phone': '03 22 66 88 13'}, {'name': 'Jean-Phillipe LANOIX', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Service de Pathologies infectieuses et tropicales, Hôpital Nord, CHU d'Amiens", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49100', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'DUBEE Vincent, Dr', 'role': 'CONTACT', 'email': 'vincent.dubee@chu-angers.fr', 'phone': '06 65 80 70 22'}, {'name': 'DUBEE Vincent, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU ANGERS - Service des maladies infectieuses et tropicales', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25030', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine CHIROUZE, Pr', 'role': 'CONTACT', 'email': 'cchirouze@chu-besancon.fr', 'phone': '03 22 66 88 13'}, {'name': 'Catherine CHIROUZE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service des Maladies infectieuses et Tropicales, Hôpital Jean Minjoz, CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '93009', 'city': 'Bobigny', 'status': 'WITHDRAWN', 'country': 'France', 'facility': 'Service de maladies infectieuses et tropicales, Hôpital Avicenne, APHP', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '33000', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabrice CAMOU, Dr', 'role': 'CONTACT', 'email': 'fabrice.camou@chu-bordeaux.fr', 'phone': '05 56 79 58 30'}, {'name': 'Fabrice CAMOU', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de Réanimation médicale, Hôpital St André, CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '92104', 'city': 'Boulogne-Billancourt', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elisabeth ROUVEIX NORDON, Pr', 'role': 'CONTACT', 'email': 'elisabeth.rouveix@apr.aphp.fr', 'phone': '01 49 09 56 45'}, {'name': 'Elisabeth ROUVEIX NORDON', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de médecine interne, Hôpital Ambroise Paré, APHP', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '29609', 'city': 'Brest', 'status': 'WITHDRAWN', 'country': 'France', 'facility': 'Service de Maladies infectieuses, Hôpital de la Cavale Blanche, CHU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '69677', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François DELAHAYE, Pr', 'role': 'CONTACT', 'email': 'francois.delahaye@chu-lyon.fr', 'phone': '04 72 35 76 28'}, {'name': 'François DELAHAYE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de Cardiologie, Hôpitall Louis Pradel, Hôpitaux Est, Hospices Civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '14033', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Renaud VERDON, Pr', 'role': 'CONTACT', 'email': 'verdon-r@chu-caen.fr', 'phone': '02 31 06 47 14'}, {'name': 'Renaud VERDON', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service Maladies Infectieuses et tropicales, Hôpital Côte de Nacre, CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '73011', 'city': 'Chambéry', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel FORESTIER, Dr', 'role': 'CONTACT', 'email': 'emmanuel.forestier@ch-metropole-savoie.fr', 'phone': '04 79 96 58 47'}, {'name': 'Emmanuel FORESTIER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de Maladies infectieuses et tropicales médecine interne, CH Métropole Savoie', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Magali VIDAL, Dr', 'role': 'CONTACT', 'email': 'mvidal@chu-clermontferrand.fr', 'phone': '04 73 75 44 05'}, {'name': 'Magali VIDAL', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service des maladies infectieuses et tropicales, Hôpital G. Montpied, CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '94010', 'city': 'Créteil', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'LEPEULE Raphael, Dr', 'role': 'CONTACT', 'email': 'raphael.lepeule@aphp.fr', 'phone': '01 49 81 22 11'}, {'name': 'LEPEULE Raphael, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP Henri-Mondor - Service des maladies infectieuses et tropicales', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '21079', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lionel PIROTH, Pr', 'role': 'CONTACT', 'email': 'lionel.piroth@chu-dijon.fr', 'phone': '03 80 29 36 31'}, {'name': 'Lionel PIROTH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Département d'infectiologie, Complexe Bocage, Hôpital d'enfants, CHU de Dijon", 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '59507', 'city': 'Douai', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier LEMAIRE, Dr', 'role': 'CONTACT', 'email': 'xljhe@yahoo.fr', 'phone': '03 27 94 74 50'}, {'name': 'Xavier LEMAIRE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de Médecine interne polyvalente et neurologique CH de Douai', 'geoPoint': {'lat': 50.37069, 'lon': 3.07922}}, {'zip': '92380', 'city': 'Garches', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aurélien DINH, Dr', 'role': 'CONTACT', 'email': 'aurelien.dinh@aphp.fr', 'phone': '01 47 10 44 32'}, {'name': 'Aurélien DINH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de médecine aigue spécifique, Hôpital Raymond Poincaré, APHP', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'zip': '85025', 'city': 'La Roche-sur-Yon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thomas GUIMARD, Dr', 'role': 'CONTACT', 'email': 'thomas.guimard@chd-vendee.fr', 'phone': '02 51 44 63 85'}, {'name': 'Thomas GUIMARD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de médecine post-urgence, infectiologie, Site de la Roche sur Yon, CHD Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '38700', 'city': 'La Tronche', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier EPAULARD, Pr', 'role': 'CONTACT', 'email': 'OEpaulard@chu-grenoble.fr', 'phone': '04 76 76 52 91'}, {'name': 'Olivier EPAULARD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de Médecine infectieuse, Hôpital Nord Michallon, CHU de Grenoble', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '78150', 'city': 'Le Chesnay', 'status': 'WITHDRAWN', 'country': 'France', 'facility': 'Service de Maladies infectieuses et tropicales, et pathologie VIH, Hôpital A Mignot, CH de Versailles', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'ESCAUT Lelia, Dr', 'role': 'CONTACT', 'email': 'lelia.escaut@bct.aphp.fr', 'phone': '01 45 21 74 26'}, {'name': 'ESCAUT Lelia, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP BICETRE - Service des maladies infectieuses et tropicales', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '72037', 'city': 'Le Mans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hikombo HITOTO', 'role': 'CONTACT', 'email': 'hhitoto@ch-lemans.fr', 'phone': '02 43 43 26 14'}, {'name': 'Hikombo HITOTO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service des Maladies infectieuses et tropicales, CH Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Karine FAURE, Pr', 'role': 'CONTACT', 'email': 'karine.faure@chru-lille.fr', 'phone': '03 20 44 57 43'}, {'name': 'Karine FAURE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Unité médicale d'infectiologie, Hôpital Huriez, CHU de Lille", 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'status': 'WITHDRAWN', 'country': 'France', 'facility': 'Service de Maladies Infectieuses et tropicales, Hôpital Dupuytren, CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69337', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Franck SIBELLAS, Dr', 'role': 'CONTACT', 'email': 'fsibellas@capio.fr', 'phone': '04 72 20 28 00'}, {'name': 'Franck SIBELLAS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique de la sauvegarde', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'WITHDRAWN', 'country': 'France', 'facility': 'Service de Maladies infectieuses, Hôpital Gui de CHauliac, CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David BOUTOILLE, Pr', 'role': 'CONTACT', 'email': 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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.\n\nOpen 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/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}