Randomised Controlled Trial of Preventive Treatment of Latent Tuberculosis Infection in Patients with Diabetes Mellitus

Project Information

PROTID

Grant agreement ID: 101145612

DOI

10.3030/101145612

EC signature date 18 May 2024

Start date 1 July 2024

End date 31 December 2026

Funded under

• Health

Total cost

€ 2 337 586,25

EU contribution

€ 2 337 586,25

Coordinated by

STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM
Netherlands

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Deliverables

Documents, reports (10)

Collection of documents related to the status of the clinical trial
Study initiation package

Study initiation package including: •Registration number of the clinical study in a registry meeting WHO Registry criteria •Final version of study protocol as approved by the regulator(s) / ethics committee(s)•Regulatory and ethics (if applicable, institutional) approvals required for the enrolment of the first study participant

Report on the status of posting results for the screening people with DM for TB

Summary results posted in the applicable registry/ies

Population impact

Population Impact of LTBI screening for DM

Midterm recruitment report

The report includes an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.

Annual consortium meetings 1

Plan and hold annual consortium meeting

Performance of CAD4TB system

Evaluation of use of the CAD4TB system for active TB screening

Data sharing policy

Updated Data sharing policy, which will be updated continuously

Plan for dissemination and exploitation, including publication policy

Updated plan for dissemination and exploitation including communication activities

TB, HIV and LTBI prevalence in DM

Prevalence of LTBI, and TB and HIV disease among people with DM

Data Management Plan (1)

Data management plan

Initial data management plan delivered at the start of the project

Websites, patent fillings, videos etc. (1)

Project website

Project website showing all work package leads