N/A
Completed N=28
Sepsis-Associated Purpura Fulminans International Registry - Europe
Source: ClinicalTrials.gov NCT02238795 ↗Enrolled (actual)
28
Serious AEs
3.9%
Results posted
May 2025
Primary outcomePrimary: Mortality — 11 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality |
11 | — |
| SECONDARY Hospital Stay |
16 | — |
| SECONDARY Extent and Severity of Purpura Fulminans Lesions |
6.3 | — |
| SECONDARY Mean Total Sepsis-related Organ Failure Assessment (SOFA) Score |
12.6 | — |
| SECONDARY Protein C |
8 | — |
| SECONDARY Duration of ICU Stay |
11.5 | — |
| SECONDARY Adverse Drug Reactions: Visual Nerve Damage |
1 | — |
| SECONDARY Adverse Drug Reaction: Bleeding |
— | — |
| SECONDARY Adverse Drug Reaction: Thrombotic Events |
— | — |
| SECONDARY Amputation |
6 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of sepsis and Purpura fulminans
- Signed informed consent
Exclusion Criteria
- Premature neonates (below gestational age of 36 weeks)
Data sourced from ClinicalTrials.gov (NCT02238795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.