A retrospective study of cefiderocol real world outcomes & safety in the treatment of patients with Gram-negative bacterial infections in the USA & EU
Objectif(s) de la recherche et intérêt pour la santé publique
Objectifs poursuivis
Domaines médicaux investigués
Bénéfices attendus
This observational study will add to the body of knowledge on the use of cefiderocol in the real world in the United States and the EU. It will also provide the desired safety information in patients treated with cefiderocol at approved doses over time in a real environment. The collection of data at the hospital level makes it possible to establish a link between the diagnostic, medication and microbiology data of hospitalized patients (if applicable); such a link is not taken into account by the secondary health care databases currently available in these countries.
Données utilisées
Catégories de données utilisées
Source de données utilisées
Acteurs finançant et participant à l'étude
Responsable(s) de traitement
Type de responsable de traitement 1
Responsable de traitement 1
Représentant du responsable de traitement 1
Responsable(s) de mise en oeuvre non cités comme responsable de traitement
Responsable de mise en oeuvre non cité comme responsable de traitement 1
Calendrier du projet
Base légale pour accéder aux données
Encadrement réglementaire
Numéro d'autorisation CNIL
Durée de conservation aux fins du projet (en années)
20
Fondement juridique
Article 6 du RGPD (Licéité du traitement)
Article 9 du RGPD (Exception permettant de traiter des données de santé)
Transfert de données personnelles vers un pays hors UE
Only fully anonymised data will be transferred outside the EU.
Droits des personnes
The data for each patient will be entered into the online data entry portal by research staff responsible for the patients care. The data is pseudonymized data with an identification key that is comprised of a site ID number, as generated by the US CRO and a sequential patient ID number as entered by each study site. The patient ID number is assigned by the individual site... . EU data will be uploaded to an EU server and the US data to a US server initially... . Once the Principal Investigator has approved the patient’s chart information and data validation has been completed, the data will undergo encryption and become incorporated into the fully anonymized dataset. This will occur on a patient by patient basis. Fully anonymized data cannot be linked to the original patient nor the site and will no longer be accessible or identifiable to the chart reviewer or the investigator. At the end of the study, all the pseudonymized data within each site’s account on the online portal will be destroyed... . The fully anonymized data will be transferred electronically from each regional server to the data controller's secure server in the US using a secure file transfer protocol. This fully anonymized, pooled data will be the basis for creating the analytic datasets to be used by the data controller for review and analysis... . As per Article 11 of GDPR regulation, the controller will receive fully anonymized data therefore Articles 15 to 20 of the GDPR regulation do not apply.