Sepsis, SeverePhase 2ReActiF-ICENCT05442710
Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy
A Phase 2 study testing ARTICE in people with Sepsis, Severe, run by Artcline GmbH at 20 sites in Germany.
Trial summary
Evaluation of a novel therapy approach for severe sepsis patients. Subjects randomized into the treatment arm receive treatment with an immune cell perfusion system on top of standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Severe
- What is being tested?
- ARTICE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 20 sitesGermany
- Study dates
- 24 Jul 2022to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Adult subjects
- ≥ 18 years of age
- with septic shock, defined as those with septic shock according to" Sepsis-3-Definition" who additionally require norepinephrine at a dose of ≥ 0.15 mcg/kg/min (and/or vasopressin at any dose) for a minimum of 6 hours (within the last 48 hours), to maintain a MAP ≥65 mmHg
- Subjects ≥ 80 years of age shall have a Clinical Frailty Scale of <5 to be enrolled.
- Fulfillment of the definition of septic shock, not longer than 48h before randomization. I.e. the 48h start at the end of the 6h period.
- Blood lactate >2 mmol/L despite adequate volume resuscitation during the current sepsis episode
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- Source control achieved / in progress in the judgement of the investigator
- Subjects are required to have central venous access and an arterial line, and these are expected to remain present for at least the initial 48 hours of study.
- Subjects must have received adequate volume replacement in the judgement of the investigator.
- Subject or legal surrogate is willing and able to provide written informed consent and comply with all protocol requirements or confirmation of the urgency of participation in the clinical trial and the possible benefit to the subject by an independent consultant or the implementation of other established procedures according to the local regulations of the contributing centre to include subjects who are unable to provide informed consent.
Who cannot join
- Acute or chronic leukemia,
- Bilirubin ≥ 2 mg/dL (≥33 µmol/L),
- Ongoing (concomitant) or prior within the last 6 month any chemotherapy or radiotherapy for malignancy,
- Autoimmune disease with systemic medication of ≥10 mg prednisolone equivalent,
- Previous transplantation,
- Subjects receiving interferon therapy (14 days prior randomisation),
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- Acute pulmonary embolism within the last 72 hours,
- Ischemic stroke or intracranial bleeding within the last 3 months
- Suspicion of concomitant acute coronary syndrome based on clinical symptoms and/or ECG within the last 72 hours,
- Cardiopulmonary resuscitation within last 7 days,
- Moribund subject (life expectancy <72 hours), in the judgement of the investigator
- Presence of a do-not-resuscitate or do-not-intubate order,
- Known HIV infection or chronic viral hepatitis,
- Isolated Urosepsis,
- Pregnancy/nursing period,
- Primary cause of hypotension not due to sepsis (e.g. major trauma including traumatic brain injury, haemorrhage, burns, or congestive heart failure/cardiogenic shock),
- Previous sepsis with ICU admission within this hospital stay,
- Known/suspected acute mesenteric ischaemia,
- Chronic mechanical ventilation for any reason OR severe COPD requiring either continuous daily oxygen use during the preceding 30 days or mechanical ventilation (for acute exacerbation of COPD) during the preceding 30 days,
- Decision to limit full care taken before obtaining informed consent,
- Prior enrolment in the trial,
- Prior use of an investigational medicinal product within the last month OR planned or concurrent participation in a clinical trial for any investigational drug or device,
- multiple injuries including polytrauma and burn >20% TBSA (2° or 3°),
- Diagnosed and documented pre-existing dementia,
- Severe Covid-Pneumonia
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
Germany20 sites, 19 recruiting
- Recruiting
Helios Klinikum Aue
Aue, Saxony, 08280
Katrin Baumann, RN, +493771583614, Katrin.Baumann2@helios-gesundheit.de
Jan Wallenborn, PD Dr. med.
- Recruiting
Charité Berlin, Klinik mit Schwerpunkt Nephrologie und internistische Intensivmedizin
Berlin, 10117
Philipp Enghard, Prof Dr., +4930450614016, philipp.enghard@charite.de
Daniel Zickler, PD Dr., +4930450614016, daniel.zickler@charite.de
- Recruiting
Universitätsklinikum Bonn, Klinik und Poliklinik für Anästhesiologie und Operative Intensivmedizin
Bonn, North Rhine-Westphalia, 53127
Ute Lohmer, RN, +4922828719069, ute.lohmer@ukbonn.de
Christian Putensen, Prof. Dr.
- Recruiting
Klinikum Braunschweig, Medizinische Klinik V
Braunschweig, 38126
Jan Kielstein, Prof. Dr., +495315952 ext. 381, j.kielstein@klinikum-braunschweig.de
Manuela Winkler, RN, +495315952 ext. 855, m.winkler@klinikum-braunschweig.de
- Recruiting
Universitätsklinikum Köln, Klinik für Anästhesiologie und Operative Intensivmedizin
Cologne, North Rhine-Westphalia
Melanie Walther, +4922147842 ext. 113, melanie.walther@uk-koeln.de
Fabian Dusse, PD Dr.
- Recruiting
Universitätsklinikum Essen, Klinik für Nephrologie
Essen, 45147
Katharina Graf-Rach, RN, +49 201723 ext. 83293, Katharina.Graf-Rach@uk-essen.de
Raffalea Kirchmeyer, RN, +49 201723 ext. 83293, Raffaela.Kirchmeyer@uk-essen.de
- Not yet recruiting
University Hospital Frankfurt, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy
Frankfurt, 69590
Anna Carina Materna, RN, +49 69 6301-86714, AnnaCarina.Materna@unimedizin-ffm.de
Kai Zacharowski, Prof Dr. Dr.
- Withdrawn
Universitätsklinikum Freiburg, Interdisziplinäre Medizinische Intensivtherapie (IMIT)
Freiburg im Breisgau, Baden-Wurttemberg, 79106
- Recruiting
Universitätsklinikum Halle (Saale), Universitätsklinik für Anästhesiologie und Operative Intensivmedizin
Halle, Saxony-Anhalt, 06120
Annett Christel, RN, 00493455572 ext. 115, Annett.christel@uk-halle.de
Daniel Ebert, MD
- Recruiting
Helios Klinikum HIldesheim
Hildesheim, 31135
Christian Theis, MD, +49 5121 894 3302, Christian.Theis@helios-gesundheit.de
Christian Theis, MD
- Recruiting
UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, 24105
Nina Schulz-Ruhtenberg, RN, 0431 500 20 ext. 975, Nina.Schulz-Ruhtenberg@uksh.de
Corinna Buchholz, RN, 043150020 ext. 975, Corinna.Buchholz@uksh.de
- Recruiting
Universitätsklinikum Leipzig, Klinik und PK für Anästhesiologie und Intensivtherapie
Leipzig, Saxony, 04103
Antje Seidel, RN, +49 341 97 17 ext. 136, Antje.Seidel@medizin.uni-leipzig.de
Falk Fichtner, MD
- Recruiting
Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin
Magdeburg, 39130
Martin Sauer, Pof. Dr., +49391791 ext. 3105, martin.sauer@klinikum-magdeburg.de
Brigitte Specht, RN, +49391791 ext. 7839, brigitte.specht@klinikum-magdeburg.de
- Recruiting
University Medical Center Mainz, Study center for Anesthesiology
Mainz, 55131
Christine Ziegelmayer, RN, +49 6131 17 ext. 2816, christine.ziegelmayer@unimedizin-mainz.de
Marc Bodenstein, Prof. Dr.
- Recruiting
Universitätsklinikum Mannheim
Mannheim, 69167
Amanda Schölch, RN, +49 621 383-1492, Amanda.Schoelch@umm.de
Simon Lindner, MD
- Recruiting
University Hospital Minden, Departmenr of Anaesthesiology, intensive and emergency care
Minden, 32429
Anja Diekmann, +49 0571 790 ext. 4401, Anaesthesie-Minden@muehlenkreiskliniken.de
Gerrit Jansen, PD Dr. med.
- Recruiting
Klinikum Oldenburg, Universitätsklinik für Anästhesiologie/ Intensivmedizin
Oldenburg, 26133
Simon Schäfer, Prof. Dr., +4944140370 ext. 773, Guenther.Ulf@klinikum-oldenburg.de
Anja Diers, RN, +4944140377 ext. 745, Diers.Anja@klinikum-oldenburg.de
- Recruiting
Universitätsklinikum Regensburg, Klinik für Anästhesiologie
Regensburg, Bavaria, 93053
Yvonne Depta, RN, Yvonne.Depta@klinik.uni-regensburg.de
Alexander Dejaco, Dr. med
- Recruiting
Universitätsmedizin Rostock, Abteilung KAI
Rostock
Daniel Reuter, Prof. Dr., +49381-494 ext. 6401, Daniel.Reuter@med.uni-rostock.de
Heike Lösecke, RN, +49381494 ext. 146447, Heike.Loesecke@med.uni-rostock.de
- Recruiting
Helios Kliniken Schwerin, Department for intensive care
Schwerin, 19055
Daniela Schumann, RN, +49 385 520 ext. 7372, Daniela.Schumann@helios-gesundheit.de
Maren Burmeister, MD
About this study
Evaluation of a novel therapy approach for severe sepsis patients. Subjects randomized into the treatment arm receive treatment with an immune cell perfusion system on top of standard care.
This may contribute to the improvement of the impaired organ function of septic shock patients by assisting the impaired immune system (immune competence enhancement = ARTICE)
- Conditions
- Sepsis, Severe
- Being tested
- ARTICE
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTICEBiological
Extracorporal treatment with purified granulocyte concentrate
| Study group | Role | What they receive |
|---|---|---|
| ARTICE Treatment Group | Experimental | Subjects with septic shock treated with immune cell extracorporeal therapy on top of standard of care Receives: Biological: ARTICE |
| Control Group | No intervention | Subjects with septic shock receiving standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of the ARTICE therapy, composed of new onset of serious adverse events from re-evaluation on Day 2 through Day 28
The number [n] of new onsets of serious adverse events (SAEs) from re-evaluation-Day 2 through Day 28 will be counted in both arms and the difference between groups will be compared.
Measured: From re-evaluation on Day 2 through Day 28
Secondary outcomes (23)
All cause mortality through Day 28
The difference in all-cause mortality from re-evaluation on Day 2 through Day 28 will be measured by time to event and Relative risk as well as Kaplan-Meier estimates with 95%-CI will be calculated through day 28
Measured: From re-evaluation on Day 2 through Day 28
All cause mortality through Day 90
The difference in all-cause mortality from re-evaluation on Day 2 through Day 90 will be measured by time to event and Relative risk as well as Kaplan-Meier estimates with 95%-CI will be calculated through day 90
Measured: From re-evaluation on Day 2 through Day 90
All-cause in-hospital mortality
The difference in all-cause mortality from re-evaluation on Day 2 through hospital discharge will be measured by time to event and Relative risk as well as Kaplan-Meier estimates with 95%-CI will be calculated through hospital discharge.
Measured: From re-evaluation on Day 2 through until hospital discharge
Daily changes in total SOFA and SOFA sub-scores
The SOFA (Sequential organ failure assessment score) Score URL"Sequential Organ Failure Assessment (SOFA) Score - MDCalc" is measured by addition of 6 Subscores for each of the 6 Organs between 1 and 4 [n]. The Change from Baseline (COBL) inbetween groups will be compared daily until day 10.
Total score ranges from 0 (best) to 24 (worst); Subscores range from 0 (best) to 4 (worst)
Measured: Until Day 10
Time course of key inflammatory/ immunological markers in between the two groups.
Time course of key inflammatory/ immunological markers including mHLA-DR and cytokines, measured by their concentration in plasma in pg/mL or in % (HLA-DR) until day 28. Their plasma concentration will be compared by each day inbetween groups.
Measured: From re-evaluation on Day 2 until Day 28
Time to complete organ failure resolution
The Time to complete organ failure resolution of the 6 organs of the SOFA system (measured as the time from a Baseline value>1 until the score/subscore is 0) through Day 14 and Day 21 will be measured and the time to resolution for all failed organs as a Kaplan Meier Model.
Measured: From re-evaluation on Day 2 until Day 28 with special focus on D14 an D21
ICU length of stay Measured / Confirmed on day 28 retrospectively. Units: Days
ICU length of stay (through Day 28) will be measured as days [n] in the ICU and compared in between the groups
Measured: Until Day 28
Number of hospital-free days. Measured / Confirmed on day 28 retrospectively. Units: Days
Hospital length of stay and number of hospital-free days (through Day 28), measured by number of days [n] will be compared between groups Units: Days
Measured: Until Day 28
Number of ICU-free days Measured / Confirmed on day 28 retrospectively. Units: Days
ICU length of stay and number of ICU-free days (through Day 28), measured by number of days [n] will be compared between groups Units: Days
Measured: Until day 28
Number of vasopressor- free days
Number of vasopressor- free days [n], until Day 28 Measured / Confirmed on day 28 retrospectively. Units: Days
Measured: From re-evaluation on Day 2 until Day 28
Number of mechanical-ventilator-free days
Number of mechanical-ventilator-free days [n], until Day 28 Measured / Confirmed on day 28 retrospectively. Units: Days
Measured: From re-evaluation on Day 2 until Day 28
Number of renal-replacement-free days
Number of renal-replacement-free days [n] until Day 28. Measured / Confirmed on day 28 retrospectively. Units: Days
Measured: From re-evaluation on Day 2 until Day 28
Number of days without antimicrobial therapy
Number of days [n] without antimicrobial therapy, until Day 28. Measured / Confirmed on day 28 retrospectively. Units: Days
Measured: From re-evaluation on Day 2 until Day 28
Frequency of secondary infections
Frequency of secondary infections [n], until Day 28. Measured / Confirmed on day 28 retrospectively. Units: total number and days
Measured: From re-evaluation on Day 2 until Day 28
Antibiotic exposure days until hospital discharge
Antibiotic exposure days [n] until hospital discharge (maximum until Day 28). Measured / Confirmed on day 28 retrospectively. Units: Days
Measured: From re-evaluation on Day 2 until Day 28
Days [n] alive without antibiotics until hospital discharge
Days alive without antibiotics until hospital discharge (maximum until Day 28). Measured / Confirmed on day 28 retrospectively. Units: Days
Measured: From re-evaluation on Day 2 until Day 28
Total daily dose of noradrenalin (NA) administered on each day
Total daily dose of noradrenalin (NA) administered on each day measured in mg/kg between Day 2 and Day 10 will be compared in between groups.
Measured: From re-evaluation on Day 2 until Day 10
Maximum daily dose of noradrenalin administration on treatment days
Maximum daily dose of noradrenalin administration on treatment days between Day 2 and Day 10 (applied for a minimum of 30 min) will be measured as µg/kg/min and compared between the groups for each day until day 10.
Measured: From re-evaluation on Day 2 until Day 10
Occurrence of virus induced inflammation episodes
Occurrence of virus induced inflammation episodes, especially reactivation of CMV, HSV etc. will be counted as an (S)AE until 28 and the number [n] will be compared between groups.
Measured / Confirmed on day 28 retrospectively.
Measured: From re-evaluation on Day 2 until Day 28
Quality of life assessment
Quality of life assessed at baseline, Day 28 and Day 90 using EQ-5D-5L Score [n] and compared between the groups.
EQ-5D-5L' is not an abbreviation, it can be described as "EuroQuol - 5 Dimensions - 5 Levels". It considers five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression at 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers result in a 1-digit number for each dimension. The digits (1= no problem to 5=extreme problems) can be combined into a 5-digit number that describes the patient's health state. 11111 indicates no problems on any of the five dimensions.
The EQ VAS visual analogue scale records the patient's self-rated health. The endpoints are labelled 'The best health you can imagine' (=100) and 'The worst health you can imagine' (=0).
Measured: Until day 90
Occurrence of cognitive decline
Occurrence of cognitive decline at Day 90 compared with baseline and between groups (measured by IQCODE (Questionnaire on cognitive decline in the elderly); [n]) will be compared between groups.
The IQCODE is scored by averaging the ratings across 26 everyday situations. A person without cognitive decline will have an average score of 3, while scores above 3 indicate that some decline has occurred
Measured: Until day 90
Time course of key biomarkers of neuroaxonal injury
Time course of key biomarkers of neuroaxonal injury (pg/ml) will be measured in the blood of study patients at predefined time points to assess changes in biomarker levels longitudinally over the course of the disease by comparing them in between groups daily.
Measured: Until day 28
Inflammatory mRNA profiling analysis
In patients, giving extra informed consent, inflammatory mRNA profiling measured by mRNA occurrence will be analyzed at Day 2 and Day 10 and compared in between Groups.
Measured: until day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start24 Jul 2022
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis, SevereStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, randomized, controlled parallel-group study
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artcline GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zentrum für Klinische Studien Jena, RQM+
- Responsible party
- Sponsor
- Investigators
- Daniel Reuter, Prof.Dr., Principal investigator, University Hospital Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442710
- Sponsor's protocol ID
- ReActIF-ICE_ZKSJ0124
- Acronym
- ReActiF-ICE
- Status last verified
- May 2025
- First submitted
- 7 Jun 2022
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy
- ClinicalTrials.gov ID
- NCT05442710
- Acronym / sponsor ID
- ReActiF-ICE / ReActIF-ICE_ZKSJ0124
- Conditions
- Sepsis, Severe
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Artcline GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Zentrum für Klinische Studien Jena, RQM+
- Study start
- 24 Jul 2022 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 5 Jul 2022 (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.
Evaluation of a novel therapy approach for severe sepsis patients. Subjects randomized into the treatment arm receive treatment with an immune cell perfusion system on top of standard care.
This may contribute to the improvement of the impaired organ function of septic shock patients by assisting the impaired immune system (immune competence enhancement = ARTICE)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicenter, randomized, controlled parallel-group study
| Arm | Type | Receives |
|---|---|---|
| ARTICE Treatment Group | Experimental | Biological: ARTICESubjects with septic shock treated with immune cell extracorporeal therapy on top of standard of care |
| Control Group | No intervention | –Subjects with septic shock receiving standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult subjects
- Fulfillment of the definition of septic shock, not longer than 48h before randomization. I.e. the 48h start at the end of the 6h period.
- Blood lactate >2 mmol/L despite adequate volume resuscitation during the current sepsis episode
- Source control achieved / in progress in the judgement of the investigator
- Subjects are required to have central venous access and an arterial line, and these are expected to remain present for at least the initial 48 hours of study.
Key exclusion criteria (25 listed)
- Acute or chronic leukemia,
- Bilirubin ≥ 2 mg/dL (≥33 µmol/L),
- Ongoing (concomitant) or prior within the last 6 month any chemotherapy or radiotherapy for malignancy,
- Autoimmune disease with systemic medication of ≥10 mg prednisolone equivalent,
- Previous transplantation,
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 |
|---|---|---|
| ARTICEExtracorporal treatment with purified granulocyte concentrate | Biological | ARTICE Treatment Group |
Primary outcome
Safety and tolerability of the ARTICE therapy, composed of new onset of serious adverse events from re-evaluation on Day 2 through Day 28
Time frame: From re-evaluation on Day 2 through Day 28
The number [n] of new onsets of serious adverse events (SAEs) from re-evaluation-Day 2 through Day 28 will be counted in both arms and the difference between groups will be compared.
23 secondary outcomes
All cause mortality through Day 28
Time frame: From re-evaluation on Day 2 through Day 28
All cause mortality through Day 90
Time frame: From re-evaluation on Day 2 through Day 90
All-cause in-hospital mortality
Time frame: From re-evaluation on Day 2 through until hospital discharge
Daily changes in total SOFA and SOFA sub-scores
Time frame: Until Day 10
Time course of key inflammatory/ immunological markers in between the two groups.
Time frame: From re-evaluation on Day 2 until Day 28
Time to complete organ failure resolution
Time frame: From re-evaluation on Day 2 until Day 28 with special focus on D14 an D21
ICU length of stay Measured / Confirmed on day 28 retrospectively. Units: Days
Time frame: Until Day 28
Number of hospital-free days. Measured / Confirmed on day 28 retrospectively. Units: Days
Time frame: Until Day 28
Number of ICU-free days Measured / Confirmed on day 28 retrospectively. Units: Days
Time frame: Until day 28
Number of vasopressor- free days
Time frame: From re-evaluation on Day 2 until Day 28
Number of mechanical-ventilator-free days
Time frame: From re-evaluation on Day 2 until Day 28
Number of renal-replacement-free days
Time frame: From re-evaluation on Day 2 until Day 28
Number of days without antimicrobial therapy
Time frame: From re-evaluation on Day 2 until Day 28
Frequency of secondary infections
Time frame: From re-evaluation on Day 2 until Day 28
Antibiotic exposure days until hospital discharge
Time frame: From re-evaluation on Day 2 until Day 28
Days [n] alive without antibiotics until hospital discharge
Time frame: From re-evaluation on Day 2 until Day 28
Total daily dose of noradrenalin (NA) administered on each day
Time frame: From re-evaluation on Day 2 until Day 10
Maximum daily dose of noradrenalin administration on treatment days
Time frame: From re-evaluation on Day 2 until Day 10
Occurrence of virus induced inflammation episodes
Time frame: From re-evaluation on Day 2 until Day 28
Quality of life assessment
Time frame: Until day 90
Occurrence of cognitive decline
Time frame: Until day 90
Time course of key biomarkers of neuroaxonal injury
Time frame: Until day 28
Inflammatory mRNA profiling analysis
Time frame: until day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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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.
Daniel Reuter, Prof.Dr. principal investigator
University Hospital Rostock
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARTICE in people with Sepsis, Severe, run by Artcline GmbH at 20 sites in Germany.
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 10 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens Altrichter, MD (+49 381-440-703 ext. 0, jens.altrichter@artcline.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of the ARTICE therapy, composed of new onset of serious adverse events from re-evaluation on Day 2 through Day 28 (time frame: From re-evaluation on Day 2 through Day 28). 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 25 May 2025.