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CompletedNCT03770533IDEALUpdated Dec 12, 2019

Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using MR-proADM - Pilot Study

An interventional study of MR-proADM guided in Patients Presenting With Suspicion of Infection to the ED, sponsored by Brahms AG. Completed at 4 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-12.

Sponsored by Brahms AG · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Emergency departments (ED) are becoming increasingly over-crowded, with patients facing prolonged waiting times. Therefore, a safe and rapid assessment that identifies patients with low severity that could be treated as outpatients is essential for improving the workflow within the ED.

The rationale of this IDEAL study is to provide guidance to safely decrease the number of hospital admissions through identification of low risk patients with the biomarker MR-proADM. This will be tested in a pilot study first.

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Conditions studied

  • Patients Presenting With Suspicion of Infection to the ED
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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 200 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Brahms AG is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Consecutive patients presenting to the ED with suspicion of infection
  • Age ≥18 years
  • Written Informed Consent obtained

Exclusion criteria

Exclusion Criteria:

  • Recent major trauma or surgery
  • End stage renal failure requiring dialysis
  • Terminal disease and/or very severe medical co-morbidity where death has to be expected in the next 6 months, e.g. due to malignancy, cardiac, renal or hepatic failure
  • Patients those source of infection always requires hospital admission or never requires hospital admission.
  • Patients who cannot be discharged for other than medical reasons
  • Patient participates in any other interventional clinical trial
  • Patients with active intravenous drug use
  • Pregnant or lactating women
  • Patients who are institutionalized by official or judicial order
  • Dependents of the sponsor, the CRO, the study site or the investigator
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Other
    MR-proADM guided

    Other: MR-proADM guided

  • No intervention
    Standard Care

Interventions

  • OtherMR-proADM guided

    MR-proADM value together with routine clinical evaluation identifies patients with a low 14 day mortality risk who do not need to be hospitalized

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What researchers measure

Primary outcomes

  1. Rate of patients admitted to the hospital

    Time frame: 14 days

Secondary outcomes

  1. 28 days all-cause hospital re-admission (corrected for mortality)

    Time frame: 28 days

  2. Number of patients re-presenting to the ED within 28 days

    Time frame: 28 days

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Study locations

4 sites
  • Hospital Universitario Central de Asturias
    Oviedo, Asturias 33011, Spain
  • Hospital Universitario de Bellvitge
    Barcelona, 08907, Spain
  • Hospital Clínico San Carlos
    Madrid, 28040, Spain
  • Hospital Virgen Macarena
    Sevilla, 41009, Spain
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References and documents

Publications

  • Gonzalez Del Castillo J, Clemente-Callejo C, Llopis F, Irimia A, Oltra-Hostalet F, Rechner C, Schwabe A, Fernandez-Rodriguez V, Sanchez-Mora C, Giol-Amich J, Prieto-Garcia B, Bardes-Robles I, Ortega-de Heredia MD, Garcia-Lamberechts EJ, Navarro-Bustos C; INFURG-SEMES investigators. Midregional proadrenomedullin safely reduces hospitalization in a low severity cohort with infections in the ED: a randomized controlled multi-centre interventional pilot study. Eur J Intern Med. 2021 Jun;88:104-113. doi: 10.1016/j.ejim.2021.03.041. Epub 2021 Apr 24. PubMed 33906810 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03770533
Lead sponsor
Brahms AG
Responsible party
Sponsor
First posted
Dec 10, 2018
Start date
Dec 14, 2018
Primary completion
Dec 11, 2019
Completion
Dec 11, 2019
Last update
Dec 12, 2019

Study contacts

Juan Gonzalez del Castillo
principal investigator · Hospital Clinico San Carlos

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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