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

May 18, 2021 updated by: University Hospital, Tours

Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus (Relais Oral Dans le Traitement Des Endocardites à Streptocoques Multi-sensibles)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

324

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Aix en Provence, France, 13616
        • Withdrawn
        • Service des maladies infectieuses, Centre Hospitalier du Pays d'Aix
      • Alès, France, 30103
        • Withdrawn
        • Service de court séjour gériatrique - EMG, Centre hospitalier d'Alès
      • Amiens, France, 80054
        • Recruiting
        • Service de Pathologies infectieuses et tropicales, Hôpital Nord, CHU d'Amiens
        • Contact:
        • Principal Investigator:
          • Jean-Phillipe LANOIX
      • Angers, France, 49100
        • Recruiting
        • CHU ANGERS - Service des maladies infectieuses et tropicales
        • Contact:
        • Principal Investigator:
          • DUBEE Vincent, Dr
      • Besançon, France, 25030
        • Recruiting
        • Service des Maladies infectieuses et Tropicales, Hôpital Jean Minjoz, CHU de Besançon
        • Contact:
      • Bobigny, France, 93009
        • Withdrawn
        • Service de maladies infectieuses et tropicales, Hôpital Avicenne, APHP
      • Bordeaux, France, 33000
        • Recruiting
        • Service de Réanimation médicale, Hôpital St André, CHU de Bordeaux
        • Contact:
        • Principal Investigator:
          • Fabrice CAMOU
      • Boulogne Billancourt, France, 92104
        • Recruiting
        • Service de médecine interne, Hôpital Ambroise Paré, APHP
        • Contact:
        • Principal Investigator:
          • Elisabeth ROUVEIX NORDON
      • Brest, France, 29609
        • Withdrawn
        • Service de Maladies infectieuses, Hôpital de la Cavale Blanche, CHU Brest
      • Bron, France, 69677
        • Recruiting
        • Service de Cardiologie, Hôpitall Louis Pradel, Hôpitaux Est, Hospices Civils de Lyon
        • Contact:
        • Principal Investigator:
          • François DELAHAYE
      • Caen, France, 14033
        • Recruiting
        • Service Maladies Infectieuses et tropicales, Hôpital Côte de Nacre, CHU de Caen
        • Contact:
        • Principal Investigator:
          • Renaud VERDON
      • Chambéry, France, 73011
        • Recruiting
        • Service de Maladies infectieuses et tropicales médecine interne, CH Métropole Savoie
        • Contact:
        • Principal Investigator:
          • Emmanuel FORESTIER
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • Service des maladies infectieuses et tropicales, Hôpital G. Montpied, CHU de Clermont-Ferrand
        • Contact:
        • Principal Investigator:
          • Magali Vidal
      • Créteil, France, 94010
        • Not yet recruiting
        • APHP Henri-Mondor - Service des maladies infectieuses et tropicales
        • Contact:
        • Principal Investigator:
          • LEPEULE Raphael, Dr
      • Dijon, France, 21079
        • Recruiting
        • Département d'infectiologie, Complexe Bocage, Hôpital d'enfants, CHU de Dijon
        • Contact:
        • Principal Investigator:
          • Lionel PIROTH
      • Douai, France, 59507
        • Recruiting
        • Service de Médecine interne polyvalente et neurologique CH de Douai
        • Principal Investigator:
          • Xavier LEMAIRE
        • Contact:
          • Xavier LEMAIRE, Dr
          • Phone Number: 03 27 94 74 50
          • Email: xljhe@yahoo.fr
      • Garches, France, 92380
        • Recruiting
        • Service de médecine aigue spécifique, Hôpital Raymond Poincaré, APHP
        • Contact:
        • Principal Investigator:
          • Aurélien DINH
      • La Roche sur Yon, France, 85025
        • Recruiting
        • Service de médecine post-urgence, infectiologie, Site de la Roche sur Yon, CHD Vendée
        • Contact:
      • La Tronche, France, 38700
        • Recruiting
        • Service de Médecine infectieuse, Hôpital Nord Michallon, CHU de Grenoble
        • Contact:
        • Principal Investigator:
          • OLIVIER epaulard
      • Le Chesnay, France, 78150
        • Withdrawn
        • Service de Maladies infectieuses et tropicales, et pathologie VIH, Hôpital A Mignot, CH de Versailles
      • Le Kremlin-Bicêtre, France, 94275
        • Recruiting
        • APHP BICETRE - Service des maladies infectieuses et tropicales
        • Contact:
        • Principal Investigator:
          • ESCAUT Lelia, Dr
      • Le Mans, France, 72037
        • Recruiting
        • Service des Maladies infectieuses et tropicales, CH Le Mans
        • Contact:
        • Principal Investigator:
          • Hikombo HITOTO
      • Lille, France, 59037
        • Recruiting
        • Unité médicale d'infectiologie, Hôpital Huriez, CHU de Lille
        • Contact:
        • Principal Investigator:
          • Karine FAURE
      • Limoges, France, 87042
        • Withdrawn
        • Service de Maladies Infectieuses et tropicales, Hôpital Dupuytren, CHU de Limoges
      • Lyon, France, 69337
        • Recruiting
        • Clinique de la Sauvegarde
        • Contact:
        • Principal Investigator:
          • Franck SIBELLAS
      • Montpellier, France, 34295
        • Withdrawn
        • Service de Maladies infectieuses, Hôpital Gui de CHauliac, CHU de Montpellier
      • Nantes, France, 44093
        • Recruiting
        • Service de Maladies infectieuses et tropicales, Hôpital Hôtel Dieu, CHU Nantes
        • Contact:
      • Nice, France, 06200
        • Recruiting
        • Service d'Infectiologie, Hôpital de l'Archet, CHU de Nice
        • Contact:
        • Principal Investigator:
          • Elisa DEMONCHY
      • Niort, France, 79021
        • Recruiting
        • Service des Maladies infectieuses, CH de Niort
        • Contact:
        • Principal Investigator:
          • Simon SUNDER
      • Nîmes, France, 30029
        • Recruiting
        • Service des Maladies Infectieuses et Tropicales, Hôpital Carémeau, CHU de Nîmes
        • Contact:
        • Principal Investigator:
          • Catherine LECHICHE
      • Orléans, France, 45100
        • Recruiting
        • Service de Maladies infectieuses et tropicales, Hôpital de la Source, CHR Orléans
        • Contact:
        • Principal Investigator:
          • Laurent HOCQUELOUX
      • Paris, France, 75011
        • Not yet recruiting
        • APHP St Antoine
        • Contact:
        • Principal Investigator:
          • KRAUSE Jessica, Dr
      • Paris, France, 75015
        • Recruiting
        • Service de Microbiologie, Hôpital Européen Georges Pompidou, APHP
        • Contact:
        • Principal Investigator:
          • Jean-Luc MAINARDI
      • Paris, France, 75018
        • Recruiting
        • Service de maladies infectieuses et tropicales, Hôpital Necker, APHP
        • Contact:
        • Principal Investigator:
          • Caroline CHARLIER
      • Paris, France, 75018
        • Recruiting
        • Service de maladies infectieuses, parasitaires et tropicales, Hôpital Bichat, APHP
        • Principal Investigator:
          • Xavier Marie DUVAL
        • Contact:
      • Paris, France, 75674
        • Recruiting
        • Institut Mutualiste Montsouris - Service de médecine interne
        • Contact:
        • Principal Investigator:
          • RICHAUD Clémence, Dr
      • Pau, France, 64000
        • Recruiting
        • CH PAU - Service de Médecine interne et Maladies infectieuses
        • Contact:
          • DUMONDIN Gilles, Dr
        • Principal Investigator:
          • DUMONDIN Gilles, Dr
      • Perpignan, France, 66000
        • Withdrawn
        • Service des Maladies infectieuses et tropicales, CH de Perpignan
      • Poitiers, France, 86021
        • Recruiting
        • Service de Médecine interne, maladies infectieuses et tropicales, CHU de Poitiers
        • Contact:
        • Principal Investigator:
          • Guillaume BERAUD
      • Pringy, France, 74374
        • Recruiting
        • Infectiologie, médecine interne et médecine des voyages, CH d'Annecy
        • Contact:
      • Quimper, France, 29107
        • Recruiting
        • CH QUIMPER - Service d'infectiologie
        • Contact:
        • Principal Investigator:
          • Lydie KHATCHATOURIAN, Dr
      • Reims, France, 51092
        • Recruiting
        • Service de Médecine interne, maladies infectieuses, immunologie clinique, Hôpital R. Debré, CHU de Reims
        • Contact:
        • Principal Investigator:
          • Firouzé BANI SADR
      • Rennes, France, 35033
        • Recruiting
        • Service des maladies infectieuses et réanimation médicale, Hôpital Pontchaillou, CHU de Rennes
        • Contact:
        • Principal Investigator:
          • Pierre TATTEVIN
      • Rouen, France, 76031
        • Recruiting
        • Service des Maladies infectieuses et tropicales, Hôpital Charles Nicolle, CHU de Rouen
        • Contact:
        • Principal Investigator:
          • Claire CHAPUZET
      • Saint Malo, France, 35403
        • Recruiting
        • Service des maladies respiratoires et infectieuses, CH de St Malo
        • Contact:
        • Principal Investigator:
          • Mathieu DUPONT
      • Saint-Mande, France, 94163
        • Withdrawn
        • Service des Maladie infectieuses et tropicales, Hôpital d'instruction des armées Bégin
      • Saint-Priest-en-Jarez, France, 42270
        • Recruiting
        • CHU St Etienne - Service des maladies infectieuses et tropicales
        • Contact:
        • Principal Investigator:
          • Elisabeth BOTELHO NEVERS, Dr
      • Toulouse, France, 31059
        • Recruiting
        • Service des Maladies infectieuses et tropicales, Hôpital de Purpan, CHU de Toulouse
        • Contact:
        • Principal Investigator:
          • Lydie PORTE
      • Toulouse, France
        • Not yet recruiting
        • CHU Toulouse (Rangueil) Service de Cardiologie
        • Contact:
        • Principal Investigator:
          • PORTE Lydie, Dr
      • Tourcoing, France, 59208
        • Recruiting
        • Service Universitaire des Maladies Infectieuses et du voyageur, CH de Tourcoing
        • Contact:
      • Tours, France, 37044
        • Recruiting
        • Service de Médecine interne et maladies infectieuses, Hôpital Bretonneau, CHU de Tours
        • Contact:
      • Vandoeuvre les Nancy, France, 54511
        • Recruiting
        • Service de Maladies infectieuses et tropicales, Hôpitaux de Brabois, CHU de Nancy
        • Contact:
        • Principal Investigator:
          • François GOEHRINGER
      • Villeneuve St Georges, France, 94190
        • Recruiting
        • Consultation de Médecine Interne, maladies infectieuses et tropicales, CH intercommunal de Villeneuve St Georges
        • Contact:
        • Principal Investigator:
          • Olivier PATEY
      • Villeurbanne, France, 69625

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Left-sided IE (Defined according to Duke criteria) on native or prosthetic valve
  • due to one isolate of Streptococcus/Enterococcus sp. susceptible to amoxicillin (MCI ≤ 0.5 mg/l)
  • in an adult ≥18 year old
  • appropriate parenteral antibiotics treatment received for at least 10 days
  • in case of valvular surgery, appropriate parenteral antibiotics treatment received for at least 10 days after valvular surgery
  • planned duration of antibiotics will extend for at least 14 days at the time of randomisation i.e. a potential switch to oral treatment between Day 10 and Day 28 thus ensuring to have at least 14 days of oral therapy remaining in the experimental group
  • apyrexia (temperature < 38°C) at each time point during the last 48 hours (at least two measures/day) at the time of randomisation
  • blood cultures have been sterile for at least 5 days at the time of randomisation
  • informed, written consent obtained from patient
  • subject covered by or having the rights to French social security

Exclusion Criteria:

  • body mass index <15 kg/m² or > 40 kg/m²
  • glomerular filtration rate < 30 ml/min/1,73m²
  • patient unable or unwilling to take oral treatment (digestive intolerance, significant malabsorption) at the time of randomisation
  • expected difficulties regarding compliance with oral antibiotic treatment or follow-up (e.g. severe cognitive impairment, severe psychiatric disease...)
  • patient without entourage to support and watch him at discharge
  • valvular surgery planned within the next 6 months
  • for patients with cardiac devices (pace-maker, implantable cardiac defibrillator) and suspected device-related IE (vegetation on the leads) if removal of the device was not performed
  • breast feeding or pregnant women, or women on childbearing age without effective contraception
  • expected duration of follow-up < 7 months at the time of randomisation (e.g. expected life expectancy < 7 months, patient living abroad...)
  • past medical history of IE in the last 3 months
  • other infection requiring parenteral antibiotic therapy
  • taking of an estrogen-progesterone treatment interacting with rifampicin
  • patient with contra-indication to oral antibiotics administered in the experimental arm (i.e. amoxicillin) - including anticipated non-manageable drug interactions, and allergy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
up to 6 months after the end of antibiotic treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of symptomatic embolic events
Time Frame: up to 6 months after the end of antibiotic treatment
secondary osteo-articular, splenic or brain localization
up to 6 months after the end of antibiotic treatment
unplanned valvular surgery
Time Frame: up to 6 months after the end of antibiotic treatment
unplanned valvular surgery
up to 6 months after the end of antibiotic treatment
relapse of positive blood cultures
Time Frame: up to 6 months after the end of antibiotic treatment
relapse of positive blood cultures with the primary pathogen
up to 6 months after the end of antibiotic treatment
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
up to 6 months after the end of antibiotic treatment
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
up to 6 months after the end of antibiotic treatment
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)
up to the end of antibiotic treatment
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)
up to 6 months after the end of antibiotic treatment
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
up to 6 months after the end of antibiotic treatment
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.
up to 6 months after the end of antibiotic treatment
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).
7 days
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).
up to 6 months after the end of antibiotic treatment
Death from all-cause
Time Frame: up to 6 months after the end of antibiotic treatment
death from all-causes
up to 6 months after the end of antibiotic treatment
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
up to 6 months after the end of antibiotic treatment]
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)
up to 6 months after the end of antibiotic treatment
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.
up to the end of antibiotic treatment
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.
up to 4 weeks after randomisation
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
up to 6 months after the end of antibiotic treatment
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
up to 6 months after the end of antibiotic treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Louis BERNARD, MD,PHD, CHRU Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2016

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

January 28, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 8, 2016

Study Record Updates

Last Update Posted (Actual)

May 19, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RODEO 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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