SepsisSAPFIRENCT02238795
Sepsis-Associated Purpura Fulminans International Registry - Europe
An observational study of Sepsis, run by Jena University Hospital at 3 sites in Germany.
Trial summary
Sepsis-associated Purpura fulminans (SAPF) is a rare life-threatening condition. It is characterized by multiple skin lesions which rapidly progress to necrosis and gangrene. SAPF is a manifestation of widespread clot formation in small blood vessels which emerges secondarily to severe bacterial and viral infections. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis
- How many people
- 28 participants
- Where
- 3 sitesGermany
- Study dates
- Apr 2016to 30 Sep 2020
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with sepsis-associated Purpura fulminans
Who may be able to join
- Diagnosis of sepsis and Purpura fulminans
- Signed informed consent
Who cannot join
- Premature neonates (below gestational age of 36 weeks)
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University Hospital Jena, Klinik für Anästhesiologie und Intensivmedizin
Jena
University Hospital Jena, Klinik für Kinder- und Jugendmedizin
Jena
Klinikum der Universität München
Munich, 80337
About this study
Sepsis-associated Purpura fulminans (SAPF) is a rare life-threatening condition. It is characterized by multiple skin lesions which rapidly progress to necrosis and gangrene. SAPF is a manifestation of widespread clot formation in small blood vessels which emerges secondarily to severe bacterial and viral infections. The clinical presentation of SAPF is dominated by symptoms of severe sepsis and multiple organ failure which are further aggravated by the massive skin lesions.
At present, there are no evidence-based guidelines for the medical management of SAPF. With numerous therapeutic approaches in use, there are no consistent comparisons of their efficacy. Altered role of causal pathogens following the introduction of meningococcal and pneumococcal prophylactic vaccines also remains to be investigated.
The goal of the registry is comprehensive collection and evaluation of information concerning the epidemiology, morbidity, therapy and outcome of SAPF.
Read the detailed description
Purpura fulminans is the clinical manifestation of disseminated thrombosis in dermal and systemic microcirculation. This rare disease is frequently associated with multiple organ failure and represents a life-threatening condition with mortality exceeding 50 %. In the vast proportion of cases, the condition has been shown to emerge secondary to acquired Protein C deficiency associated with severe sepsis, mostly of meningococcal or pneumococcal origin.
A consistent therapeutic approach to sepsis-associated Purpura fulminans (SAPF) has not been established yet. With exaggerated pro-coagulant activity being confirmed as the key pathogenic aspect, several treatment modalities aiming at the balance restoration in the coagulation cascade have been considered.
SAPF causality might have been substantially altered in the wake of widespread meningococcal and pneumococcal vaccination. There are neither evidence-based treatment guidelines nor comparative evaluation of the efficacy of different therapeutic approaches.
The present registry aims at a) large-scale data accumulation and comprehensive evaluation of the incidence, causality and current treatment strategies of SAPF, b) comparative assessment of treatment strategies including or not including protein C supplementation c) identification of patient subgroups of particular eligibility for Protein C treatment, as judged by established criteria of disease severity assessment, d) feedback of aggregated data to registry contributors, thus permitting quality management and standard updates, e) dissemination of data evaluation summaries and recommendations for the use of Protein C formulations in clinical routine, f) elaboration of a framework for SAPF treatment recommendations and guidelines.
The registry comprises prospective, multicentric open-label data collection on the current state of incidence and management of SAPF, regardless of the etiopathogenic background. It will include comprehensive records on diagnosis, morbidity and management of SAPF, supplied in the form of electronic case report forms (eCRFs) by the participating centers over a period of three years.
- Conditions
- Sepsis
- Keywords
- Purpura fulminans, Sepsis, Epidemiology, Morbidity, Therapy
- Medical subject headings
- Sepsis, Purpura Fulminans
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All-cause in-hospital mortality
Measured: during hospital stay (estimated up to 3 months)
Secondary outcomes (9)
Hospital Stay
Hospital stay (in days), patients were observed through hospital stay as long as it took
Measured: duration of hospital stay, up to 3 months
Extent and Severity of Purpura Fulminans Lesions
Extent and severity of Purpura fulminans lesions: Number of lesions with purpura fulminans
Measured: 7 days
Mean Total Sepsis-related Organ Failure Assessment (SOFA) Score
Mean total Sepsis-related organ failure assessment (SOFA) score at day 7, range 0-24 points, higher scores are worse.
The total SOFA score is the sum of the subscores of central nervous system, cardiovascular system, respiratory system, coagulation, liver and renal function. The range of all subscores is from 0 to 4, with 4 points indicating the worst outcome.
Measured: day 7
Protein C
Administration of Protein C
Measured: until day 7
Duration of ICU Stay
Duration of hospitalization in an ICU
Measured: during ICU stay (estimated up to 3 months)
Adverse Drug Reactions: Visual Nerve Damage
Adverse Drug Reaction related to specific PF treatment: Visual nerve damage
Measured: during hospital stay (estimated up to 3 months)
Adverse Drug Reaction: Bleeding
Occurence of Bleeding (Adverse drug reaction)
Measured: during ICU stay
Adverse Drug Reaction: Thrombotic Events
Occurence of thrombotic events (Adverse Drug Reaction)
Measured: during ICU stay
Amputation
Need for amputation
Measured: during ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startApr 2016
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, Medical University of Vienna, University Hospital Tuebingen, University Hospital of Cologne, University Hospital, Essen, Insel Gruppe AG, University Hospital Bern, Hannover Medical School, University Hospital, Basel, Switzerland, Evangelisches Krankenhaus Bielefeld gGmbH, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Sponsor
- Investigators
- Frank M Brunkhorst, MD, Study chair, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238795
- Sponsor's protocol ID
- ZKSJ0065
- Acronym
- SAPFIRE
- Status last verified
- Mar 2025
- First submitted
- 10 Sep 2014
- Last updated
- 21 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Brunkhorst FM, Patchev V. [Sepsis-associated Purpura Fulminans International Registry--Europe (SAPFIRE)]. Med Klin Intensivmed Notfmed. 2014 Nov;109(8):591-5. doi: 10.1007/s00063-014-0402-z. Epub 2014 Oct 29. German.
PubMed 25348051
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sepsis-Associated Purpura Fulminans International Registry - Europe
- ClinicalTrials.gov ID
- NCT02238795
- Acronym / sponsor ID
- SAPFIRE / ZKSJ0065
- Conditions
- Sepsis
- Keywords
- Purpura fulminans, Sepsis, Epidemiology, Morbidity, Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, Medical University of Vienna, University Hospital Tuebingen, University Hospital of Cologne, University Hospital, Essen, Insel Gruppe AG, University Hospital Bern, Hannover Medical School, University Hospital, Basel, Switzerland, Evangelisches Krankenhaus Bielefeld gGmbH, Universitätsklinikum Hamburg-Eppendorf
- Study start
- Apr 2016
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Posted 21 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sepsis-associated Purpura fulminans (SAPF) is a rare life-threatening condition. It is characterized by multiple skin lesions which rapidly progress to necrosis and gangrene. SAPF is a manifestation of widespread clot formation in small blood vessels which emerges secondarily to severe bacterial and viral infections. The clinical presentation of SAPF is dominated by symptoms of severe sepsis and multiple organ failure which are further aggravated by the massive skin lesions.
At present, there are no evidence-based guidelines for the medical management of SAPF. With numerous therapeutic approaches in use, there are no consistent comparisons of their efficacy. Altered role of causal pathogens following the introduction of meningococcal and pneumococcal prophylactic vaccines also remains to be investigated.
The goal of the registry is comprehensive collection and evaluation of information concerning the epidemiology, morbidity, therapy and outcome of SAPF.
Detailed description
Purpura fulminans is the clinical manifestation of disseminated thrombosis in dermal and systemic microcirculation. This rare disease is frequently associated with multiple organ failure and represents a life-threatening condition with mortality exceeding 50 %. In the vast proportion of cases, the condition has been shown to emerge secondary to acquired Protein C deficiency associated with severe sepsis, mostly of meningococcal or pneumococcal origin.
A consistent therapeutic approach to sepsis-associated Purpura fulminans (SAPF) has not been established yet. With exaggerated pro-coagulant activity being confirmed as the key pathogenic aspect, several treatment modalities aiming at the balance restoration in the coagulation cascade have been considered.
SAPF causality might have been substantially altered in the wake of widespread meningococcal and pneumococcal vaccination. There are neither evidence-based treatment guidelines nor comparative evaluation of the efficacy of different therapeutic approaches.
The present registry aims at a) large-scale data accumulation and comprehensive evaluation of the incidence, causality and current treatment strategies of SAPF, b) comparative assessment of treatment strategies including or not including protein C supplementation c) identification of patient subgroups of particular eligibility for Protein C treatment, as judged by established criteria of disease severity assessment, d) feedback of aggregated data to registry contributors, thus permitting quality management and standard updates, e) dissemination of data evaluation summaries and recommendations for the use of Protein C formulations in clinical routine, f) elaboration of a framework for SAPF treatment recommendations and guidelines.
The registry comprises prospective, multicentric open-label data collection on the current state of incidence and management of SAPF, regardless of the etiopathogenic background. It will include comprehensive records on diagnosis, morbidity and management of SAPF, supplied in the form of electronic case report forms (eCRFs) by the participating centers over a period of three years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with sepsis-associated Purpura fulminans
Key inclusion criteria (2 listed)
- Diagnosis of sepsis and Purpura fulminans
- Signed informed consent
Key exclusion criteria (1 listed)
- Premature neonates (below gestational age of 36 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: during hospital stay (estimated up to 3 months)
All-cause in-hospital mortality
9 secondary outcomes
Hospital Stay
Time frame: duration of hospital stay, up to 3 months
Extent and Severity of Purpura Fulminans Lesions
Time frame: 7 days
Mean Total Sepsis-related Organ Failure Assessment (SOFA) Score
Time frame: day 7
Protein C
Time frame: until day 7
Duration of ICU Stay
Time frame: during ICU stay (estimated up to 3 months)
Adverse Drug Reactions: Visual Nerve Damage
Time frame: during hospital stay (estimated up to 3 months)
Adverse Drug Reaction: Bleeding
Time frame: during ICU stay
Adverse Drug Reaction: Thrombotic Events
Time frame: during ICU stay
Amputation
Time frame: during ICU stay
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25348051Brunkhorst FM, Patchev V. [Sepsis-associated Purpura Fulminans International Registry--Europe (SAPFIRE)]. Med Klin Intensivmed Notfmed. 2014 Nov;109(8):591-5. doi: 10.1007/s00063-014-0402-z. Epub 2014 Oct 29. German.
- Registry websiteLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Frank M Brunkhorst, MD study chair
Jena University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Jena University Hospital at 3 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 2 inclusion and 1 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 21 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 3 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mortality (time frame: during hospital stay (estimated up to 3 months)). 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 NCT02238795, which also lists 1 linked publication.
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 21 May 2025.