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.
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.
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.
- Conditions
- Infection, Bacterial, Burns, Inflammation
- 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.
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)
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
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
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.
- First posted20 May 2021
- Study start1 Apr 2021
- Primary completion30 Jun 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bohumil Bakalar MD, Charles University, Czech Republic
- Investigators
- Helena Lahoda Brodská, MD, PhD, Principal investigator, Ústav lékařské biochemie a laboratorní diagnostiky 1. LF UK a Všeobecné fakultní nemocnice Praha
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 27384242Nierhaus 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 22280231Weimann 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intensive Care Infection Score in Adult and Paediatric Burns in Comparison to Other Inflammatory Markers
- ClinicalTrials.gov ID
- NCT04894500
- Acronym / sponsor ID
- ICARUS / 0402021
- Conditions
- Infection, Bacterial, Burns, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 20 May 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted for burn injuries.
Key inclusion criteria (1 listed)
- All patients hospitalized on Prague Burn Centre, Czech Republic, for more than 3 days.
Key exclusion criteria (2 listed)
- Refusal to sign informed consent or withdrawal of already signed consent;
- Patient in palliative care.
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 |
|---|---|---|
| Flow fluorescence cytometryAlso: CRP, PCT, Presepsin, IL-6Level of inflammatory markers in body fluid samples | Diagnostic test | – |
Primary outcome
The Intensive Care Infection Score is not inferior to selected inflammatory markers in detection of bacterial infection
Time frame: 15 days
Comparison of the ICIS to CRP, PCT, IL-6, WBC, TNF-α, and Presepsin
3 secondary outcomes
The Intensive Care Infection Score is a suitable biomarker for distinguishing bacterial infection from systemic inflammatory response syndrome (SIRS)
Time frame: 30 days
The Intensive Care Infection Score does not depend on the extend and depth of the burn area
Time frame: 5 days
The Intensive Care Infection Score is a suitable marker of bacterial infection in children with burns
Time frame: 10 days
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 7 Jan 2026.
- Background: PubMed 27384242van 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.
- Background: PubMed 22280231Nierhaus 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.
- Background: PubMed 25850686Weimann 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.
- Individual participant dataSharing planned: Undecided. We plan to allow access to a database created on Google
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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.
Helena Lahoda Brodská, MD, PhD principal investigator
Ústav lékařské biochemie a laboratorní diagnostiky 1. LF UK a Všeobecné fakultní nemocnice Praha
1 site in 1 country: see every site and its status.
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.