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Infection, BacterialICARUSNCT04894500

ICIS in Burn Patients Compared to Other Inflammatory Markers

An observational study of Infection, Bacterial and Burns, run by Charles University, Czech Republic at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The current markers of inflammation that govern antibiotic treatment have their significant limitations, especially in patients with burns. According to previously published data, the newly proposed marker of infectious inflammation, the Intensive Care Infection Score (ICIS), appears to be a suitable diagnostic tool… Read more about this study

Who is it for?
Ages 6 months to 100 years
Conditions the study is for
Infection, Bacterial, Burns, Inflammation
What is being tested?
Flow fluorescence cytometry
How many people
97 participants
Where
1 siteCzechia
Study dates
1 Apr 2021to 31 Oct 2024
Phase
Observational
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 6 months to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients admitted for burn injuries.

Who may be able to join

  • All patients hospitalized on Prague Burn Centre, Czech Republic, for more than 3 days.

Who cannot join

  • Refusal to sign informed consent or withdrawal of already signed consent;
  • Patient in palliative care.

Trial locations and contacts

1 site in 1 country.

Czechia1 site
  • University Hospital Kralovske Vinohrady

    Prague, 10034

Other trials in Czechia

About this study

Official title: The Intensive Care Infection Score in Adult and Paediatric Burns in Comparison to Other Inflammatory Markers

The current markers of inflammation that govern antibiotic treatment have their significant limitations, especially in patients with burns. According to previously published data, the newly proposed marker of infectious inflammation, the Intensive Care Infection Score (ICIS), appears to be a suitable diagnostic tool in distinguishing between inflammation of infectious and non-infectious origin in these patients. The other advantage is its low price.

This study aims to compare ICIS with other used indicators of inflammation in patients with burns both children and adults.

Read the detailed description

Improving the use of antibiotics is an important patient and public health issue. The misuse of antibiotics has contributed to the growing problem of antibiotic resistance, which has become one of the most serious and growing threats to public health.

The prompt initiation of antibiotics to treat infections has been proven to reduce morbidity and save lives, however, up to 30% of all antibiotics prescribed in ITUs are either unnecessary or inappropriate. One of the key problems is early and reliable detection of infection. Specificity of clinical signs and routine laboratory markers is low and they usually cannot distinguish among changes caused by the primary insult, inflammatory reaction, and infection.

The gold standard of systemic bacterial and fungal infection, i.e. positive blood culture, has a sensitivity of less than 75 per cent and its contamination has been found in up to one third of results. Sputum and urine cultures are contaminated even more. Moreover, culture results are usually not known earlier than after 48 hours and antibiotic treatment should be started earlier in many cases, especially in the case of septic shock.

New diagnostic modalities have been developed to sort out difficulties with early and reliable diagnosis of a presence of infection, for example measurement of Procalcitonin (PCT) or Presepsin level, matrix-assisted laser desorption ionization time-of-flight detector mass spectrometry (MALDI TOF MS), DNA hybridisation, and polymerase chain reaction (PCR) tests, eventually polymerase chain reaction electrospray ionization mass spectrometry (PCR ESI-MS).

PCT examination is the most used laboratory test from the modalities mentioned above. Despite many positive characteristics (i.e. fast dynamics of plasma changes, higher sensitivity and specificity than C-reactive protein, ability to distinguish between G+ and G- infection), PCT specificity drops in patients with ARDS, burns, multiple injuries, rhabdomyolysis, lysis of lymphocytes, extreme metabolic situations, organ perfusion failure and after large surgical procedures. It is also worth mentioning the relatively high cost of this examination, limiting the use of this marker for routine screening, especially in low- and middle-income countries.

The limiting factor for the use of the other diagnostic methods mentioned above is their availability and price, or the fact that they are not reimbursed by health insurance companies. Thus, the need for a reliable, cost-effective and available marker to facilitate antibiotic therapy continues to be a burning problem, especially in intensive care, where the development of SIRS is part of the disease in many patients.

Intensive Care Infection Score (ICIS) has been proposed as a suitable diagnostic indicator for the presence of infection in these patients. Five parameters are used to calculate this score:

  • Number of neutrophil segments
  • The number of immature granulocytes
  • Mean fluorescence intensity of neutrophil segments
  • Difference in haemoglobin concentration of mature and young cells
  • Number of antibody secreting lymphocytes These parameters characterize the early innate immune response. The maximum ICIS value is 20. ICIS changes occur in the order of hours and are capable of detecting early local and systemic infection prior to the development of clinical symptoms. The advantages are the low cost of the examination which can be used to routinely screen patients, the speed of results (up to 15 min), sensitivity, assessment of the severity of infection, and the fact that no extra blood sample is needed. Measurements are done from a blood sample taken for differential blood count by flow fluorescence cytometry.

Nevertheless, ICIS suitability and accurance in both adult and pediatric burn patients has not been proved yet. This study is aimed to investigate ICIS reliability in burns.

Being tested
Flow fluorescence cytometry
Medical subject headings
Bacterial Infections, Burns, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flow fluorescence cytometryDiagnostic test

    Also called CRP, PCT, Presepsin, IL-6

    Level of inflammatory markers in body fluid samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Intensive Care Infection Score is not inferior to selected inflammatory markers in detection of bacterial infection

    Comparison of the ICIS to CRP, PCT, IL-6, WBC, TNF-α, and Presepsin

    Measured: 15 days

Secondary outcomes (3)
  1. The Intensive Care Infection Score is a suitable biomarker for distinguishing bacterial infection from systemic inflammatory response syndrome (SIRS)

    Comparison of the ICIS to microbial results

    Measured: 30 days

  2. The Intensive Care Infection Score does not depend on the extend and depth of the burn area

    Comparison of the ICIS and burn characteristics

    Measured: 5 days

  3. The Intensive Care Infection Score is a suitable marker of bacterial infection in children with burns

    Suitability of the ICIS in pediatric patients with thermic injury

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2021
  2. Study start1 Apr 2021
  3. Primary completion30 Jun 2024
  4. Study completion31 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04894500
Sponsor's protocol ID
0402021
Acronym
ICARUS
Status last verified
Aug 2023
First submitted
16 May 2021
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We plan to allow access to a database created on Google

Publications

  • van der Geest PJ, Mohseni M, Linssen J, Duran S, de Jonge R, Groeneveld AB. The intensive care infection score - a novel marker for the prediction of infection and its severity. Crit Care. 2016 Jul 7;20(1):180. doi: 10.1186/s13054-016-1366-6.

    PubMed 27384242
  • Nierhaus A, Linssen J, Wichmann D, Braune S, Kluge S. Use of a weighted, automated analysis of the differential blood count to differentiate sepsis from non-infectious systemic inflammation: the intensive care infection score (ICIS). Inflamm Allergy Drug Targets. 2012 Apr;11(2):109-15. doi: 10.2174/187152812800392841.

    PubMed 22280231
  • Weimann K, Zimmermann M, Spies CD, Wernecke KD, Vicherek O, Nachtigall I, Tafelski S, Weimann A. Intensive Care Infection Score--A new approach to distinguish between infectious and noninfectious processes in intensive care and medicosurgical patients. J Int Med Res. 2015 Jun;43(3):435-51. doi: 10.1177/0300060514557711. Epub 2015 Apr 7.

    PubMed 25850686

Questions about this trial

What is this clinical trial studying?

An observational study of Infection, Bacterial and Burns, run by Charles University, Czech Republic at 1 site in Czechia.

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 1 inclusion and 2 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 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. 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?

The Intensive Care Infection Score is not inferior to selected inflammatory markers in detection of bacterial infection (time frame: 15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04894500, which also lists 3 linked publications.

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 7 Jan 2026.

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