N° F20211018122133

A retrospective study of cefiderocol real world outcomes & safety in the treatment of patients with Gram-negative bacterial infections in the USA & EU

Partager

Objectifs de l'étude

Prévention et traitement
Sécurité des patients

Domaines médicaux

Maladies infectieuses

Catégories des données utilisées

Les données personnelles de santé que vous utilisez portent sur les caractéristiques suivantes des bénéficiaires :
Pathologies

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.

Eléments de méthode

The study will not interact with patients. This is a multi-country, retrospective patient treatment review of existing medical records in patients treated with cefiderocol for the first time. It is designed and will be conducted according to the requirements of the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP)[ENCePP, 2015] and International Society for Pharmacoepidemiology (ISPE) guidance [ISPE, 2015] and ICH GCP as

appropriate.

One electronic study questionnaire will be completed for each eligible patient at each participating site.

Origine des données

Dossiers médicaux

Population concernée

This is a multi-site, retrospective chart review of existing medical records in patients prescribed cefiderocol for at least 72 hours for the first time.

At each site, a specific chart reviewer with access to patient records will identify sequential patients who received their first cefiderocol treatment for a Gram-negative bacterial infection (GNBI) during hospitalization. At each 6-month study interval in a 2-month data collection ‘wave’, following assessment of the patient’s eligibility for the study, the reviewer will extract the following data for each eligible patient: demographics, clinical characteristics, microbiological results, antibiotic susceptibility, antibiotic usage, clinical outcome of the indicated GNBI and in-hospital mortality or discharge status from the medical charts. The reviewer will enter the extracted data, excluding any patient identifiers, into a secure, password-protected online portal. The principal study investigator will review the data and make the final submission to the online portal.

Organismes parties au projet

Type de responsable de traitement

Industriel santé

Responsable de traitement

Shionogi B.V.

UK Office, 5th Floor, 33 Kingsway, Holborn WC2B 6UF London

Délégué à la Protection des Données

Shionogi BV

UK Office, 5th Floor, 33 Kingsway, Holborn WC2B 6UF London

clare.shepherd@shionogi.eu

Représentant du responsable de traitement (si hors UE)

Non renseigné

Responsable de mise en œuvre différent du responsable de traitement

Oui
Tailored Clinical Research Solutions Ltd

5 Chancery Lane EC4A 1BL London

Calendrier et statut d'avancement

Terminé
Date de début : 01/11/2021 – Date de fin : 30/06/2023
Etape 1 : Dépôt du projet
18/10/2021
Etape 2 : Complétude
Non renseigné
?
Etape 3 : Transmission CEREES/CESREES
Non renseigné
?
Etape 4 : Statut CEREES/CESREES
Non renseigné
?
Etape 5 : Sens avis CEREES/CESREES
Non renseigné
?
Etape 6 : Avis CEREES/CESREES
Non renseigné
?
Etape 7 : Dépôt CNIL
Non renseigné
?
Etape 8 : Statut CNIL
Non renseigné
?

Décision
Non renseigné
?
Etape 9 : Entité mettant à disposition
Tiers 

Informations réglementaires

Destinataire(s) des données

Non renseigné

Durée de conservation des données aux fins du projet

20

Encadrement réglementaire

Méthodologie de référence
Numéro d’autorisation / MR : 004

Existence d’une prise de décision automatisée

Non renseigné

Base juridique

(1)(e) exécution d’une mission d’intérêt public(2)(j) archives, recherche scientifique ou historique, ou statistiques

Transfert hors UE

  Non

Garanties transfert

Only fully anonymised data will be transferred outside the EU.

Variables sensibles utilisées

Non renseigné

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.

Vous souhaitez en savoir plus sur ce projet ?

Contactez-nous