NCT02238795

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
1.6 years until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

May 21, 2025

Completed
Last Updated

May 21, 2025

Status Verified

March 1, 2025

Enrollment Period

4.5 years

First QC Date

September 10, 2014

Results QC Date

October 8, 2021

Last Update Submit

May 19, 2025

Conditions

Sepsis

Keywords

Purpura fulminans, Sepsis, Epidemiology, Morbidity, Therapy

Outcome Measures

Primary Outcomes (1)

  • Mortality

    All-cause in-hospital mortality

    during hospital stay (estimated up to 3 months)

Secondary Outcomes (9)

  • Hospital Stay

    duration of hospital stay, up to 3 months

  • Extent and Severity of Purpura Fulminans Lesions

    7 days

  • Mean Total Sepsis-related Organ Failure Assessment (SOFA) Score

    day 7

  • Protein C

    until day 7

  • Duration of ICU Stay

    during ICU stay (estimated up to 3 months)

  • +4 more secondary outcomes

Other Outcomes (3)

  • Vasopressor Days

    during ICU stay (estimated up to 3 months)

  • Ventilator-free Days

    during ICU stay (estimated up to 3 months)

  • Renal Replacement Therapy

    during ICU stay (estimated up to 3 months)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with sepsis-associated Purpura fulminans

You may qualify if:

  • Diagnosis of sepsis and Purpura fulminans
  • Signed informed consent

You may not qualify if:

  • Premature neonates (below gestational age of 36 weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital Jena, Klinik für Anästhesiologie und Intensivmedizin

Jena, Germany

Location

University Hospital Jena, Klinik für Kinder- und Jugendmedizin

Jena, Germany

Location

Klinikum der Universität München

Munich, 80337, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25348051BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma

MeSH Terms

Conditions

SepsisPurpura Fulminans

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhageSkin ManifestationsSigns and Symptoms

Results Point of Contact

Title
Prof. Dr. Frank M. Brunkhorst
Organization
Jena University Hospital, Center for Clinical Studies
frank.brunkhorst@med.uni-jena.de
+49 3641 939

Study Officials

  • Frank M Brunkhorst, MD

    Center for Clinical Studies, Jena University Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2014

First Posted

September 12, 2014

Study Start

April 1, 2016

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

May 21, 2025

Results First Posted

May 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)