Patients Presenting With Suspicion of Infection to the EDNCT05108883
Risk Stratification Using Midregional Proadrenomedullin in the ED
A study testing MR-proADM KRYPTOR in people with Patients Presenting With Suspicion of Infection to the ED, run by Brahms AG at 9 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Presenting With Suspicion of Infection to the ED
- What is being tested?
- MR-proADM KRYPTOR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 463 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 14 Oct 2021to 7 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients presenting to the ED with suspicion of infection
- Age ≥18 years
- Written Informed Consent obtained
Who cannot join
- Patients with SARS-COV-2 infection
- 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 whose source of infection always requires hospital admission or never requires hospital admission.
- Patients who cannot be discharged for other than medical reasons
Show all 11Show fewer
- Patient participates in any other interventional clinical trial
- Patients with active abusive 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
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Spain4 sites
Hospital Clinic
Barcelona, 08036
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Principality of Asturias, 33011
Hospital Virgen de la Macarena
Seville, 41009
Italy2 sites
Policlinico Tor Vergata
Roma, 00133
Hospital Santa Maria della Misericordia
Udine, 33100
United Kingdom2 sites
Hampshire Hospitals NHS Foundation Trust
Basingstoke, RG24 9NA
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
About this study
Official title: IDEntifying pAtients With Suspicion of Infection in the ED Who Have Low Disease Severity Using Midregional Proadrenomedullin (MR-proADM) - Pivotal Study
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 safely decrease the number of hospital admissions through identification of low risk patients with the biomarker MR-proADM. This will has already been tested in the IDEAL - pilot study and results should be confirmed with this IDEAL+ study.
- Being tested
- MR-proADM KRYPTOR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-proADM KRYPTORDevice
MR-proADM ≤ 0.87 nmol/L together with routine clinical evaluation identifies patients with low disease severity who do not need to be hospitalized
| Study group | Role | What they receive |
|---|---|---|
| standard care arm | No intervention | decision whether a patient will be hospitalized or be treated as out-patient is based on routine clinical assessment and usual protocols |
| MR-proADM guided arm | Experimental | decision whether a patient will be hospitalized or be treated as out-patient is based on routine clinical assessment, usual protocols and MR-proADM levels Receives: Device: MR-proADM KRYPTOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of out-patients re-presenting to the ED
Number of out-patients re-presenting to the ED
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start14 Oct 2021
- Primary completion7 Nov 2023
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Presenting With Suspicion of Infection to the EDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brahms AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108883
- Sponsor's protocol ID
- IDEAL+ Study
- Status last verified
- Mar 2025
- First submitted
- 18 Oct 2021
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IDEntifying pAtients With Suspicion of Infection in the ED Who Have Low Disease Severity Using Midregional Proadrenomedullin (MR-proADM) - Pivotal Study
- ClinicalTrials.gov ID
- NCT05108883
- Acronym / sponsor ID
- IDEAL+ Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Brahms AGIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 safely decrease the number of hospital admissions through identification of low risk patients with the biomarker MR-proADM. This will has already been tested in the IDEAL - pilot study and results should be confirmed with this IDEAL+ study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care arm | No intervention | –decision whether a patient will be hospitalized or be treated as out-patient is based on routine clinical assessment and usual protocols |
| MR-proADM guided arm | Experimental | Device: MR-proADM KRYPTORdecision whether a patient will be hospitalized or be treated as out-patient is based on routine clinical assessment, usual protocols and MR-proADM levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consecutive patients presenting to the ED with suspicion of infection
- Age ≥18 years
- Written Informed Consent obtained
Key exclusion criteria (11 listed)
- Patients with SARS-COV-2 infection
- 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 whose source of infection always requires hospital admission or never requires hospital admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-proADM KRYPTORMR-proADM ≤ 0.87 nmol/L together with routine clinical evaluation identifies patients with low disease severity who do not need to be hospitalized | Device | MR-proADM guided arm |
Primary outcome
Number of out-patients re-presenting to the ED
Time frame: 5 days
Number of out-patients re-presenting to the ED
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-proADM KRYPTOR in people with Patients Presenting With Suspicion of Infection to the ED, run by Brahms AG at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, Italy, United Kingdom, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of out-patients re-presenting to the ED (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025; AzTrials last refreshed its copy on 1 Nov 2026.