IDEAL+ V1.1
Research type
Research Study
Full title
IDEntifying pAtients with suspicion of infection in the ED who have Low disease severity using Midregional Proadrenomedullin (MR-proADM) - Pivotal study
IRAS ID
313100
Contact name
Kordo Saeed
Contact email
Sponsor organisation
B·R·A·H·M·S GmbH
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 15 days
Research summary
The aim of this study is to assess MR-proADM as a biomarker that provides accurate prognostic information in the triage and risk assessment of patients in the Emergency Department. MR-proADM together with routine clinical evaluation identifies patients with low disease severity who do not need to be hospitalized.
This multicenter clinical study enrolls patients with a suspicion of infection presenting to the ED of the participating hospitals.
After routine clinical assessment patients who meet all inclusion criteria, do not fulfill any of the exclusion criteria and give their written informed consent are randomly assigned to either a Standard Care arm or a MR-proADM guided arm.
After randomization blood will be drawn from the patients in MR-proADM guided arm as well as in Standard Care arm.
In the MR-proADM guided arm the biomarker will be measured immediately thereafter. Once biomarker results are available and all required medical information is obtained the decision on out-patient treatment will be made considering the MR-proADM measurement result. In case the clinical assessment indicates that further observation of the patient despite a low MR-proADM value (≤0.87 nmol/L) is needed, or clinical assessment indicates discharge patient despite a high MR-proADM value (>0.87 nmol/L), the patient will be monitored on an observational unit for a maximum of 24 hours. During this phase before discharge an additional clinical assessment and blood draw with MR-proADM measurement will be performed for the decision on out-patient treatment. Patients will receive treatment based on usual protocols indicated for the infection of the patients.
In the Standard Care arm, the decision whether a patient needs to be hospitalized or can be treated as out-patient and the respective treatment will be made based on routine clinical assessment and usual protocols. All patients will be followed up 28 days after randomization.REC name
North East - York Research Ethics Committee
REC reference
22/NE/0060
Date of REC Opinion
29 Apr 2022
REC opinion
Further Information Favourable Opinion