Outcomes of Purpura FULminans in Adults - The hOPeFUL Study

Henri Mondor University Hospital

Status: Completed

Conditions: Purpura Fulminans

Treatments: Other: Phone interview measuring health-related quality of life variables

Study type: Observational

Funder types: Other

Identifiers

NCT03216577

hOPeFUL

Details and patient eligibility

About

Purpura fulminans (PF) is a rare life-threatening infectious disease characterized by the association of a sudden and extensive purpura together with acute circulatory failure. The mortality of PF has been reported to be as high as 50% in previous adult series. Additionally, patients surviving to the early phase of PF are exposed to a high risk of limb amputation. The hOPeFUL study aims at assessing the short and long term outcomes of adult patients admitted in the intensive care unit for a purpura fulminans.

Full description

Purpura fulminans (PF) is a rare life-threatening infectious disease characterized by the association of a sudden and extensive purpura together with acute circulatory failure. Neisseria meningitidis and Streptococcus pneumoniae are the most frequently involved microorganisms but other species (e.g., Staphylococcus aureus, Streptococcus pyogenes, Haemophilus influenzae...) have also been reported. Despite prompt antibiotics administration and intensive care management, the mortality of PF has been reported to be as high as 50% in previous adult series. Additionally, patients surviving to the early phase of PF are exposed to a high risk of serious sequelae related to extensive skin necrosis and acral symmetrical gangrene, which typically requires limb amputations, a potential source of severe handicap in these previously young and healthy patients. Although the clinical features and outcomes of PF have been well studied in the pediatric setting, the amount of available data for adult PF are scarce, often outdated and mainly limited to patients with meningococcal infections. The current study aims at assessing the short and long-term outcomes of adult patients admitted in the intensive care unit for a purpura fulminans. A large multicenter retrospective cohort will be built in order to assess hospital outcomes (i.e., mortality and amputations). Long-term outcomes, including health-related quality variables, will be prospectively assessed among survivors and compared to septic controls (i.e., patients having septic shock non-related to purpura fulminans).

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients admitted in the intensive care unit between 2010 and 2016 for an infectious purpura fulminans and discharged alive

Exclusion criteria

• Age < 18 years
• Non infectious purpura
• Infective endocarditis

Trial design

74 participants in 2 patient groups

Exposed to purpura fulminans

Description:

Patients who were admitted in the intensive care unit and survived a purpura fulminans episode

Treatment:

Other: Phone interview measuring health-related quality of life variables

Non-exposed to purpura fulminans

Description:

Patients admitted in the intensive care unit for a septic shock unrelated to a purpura fulminans, and matched to exposed patients for age, gender, and severity of illness.

Treatment:

Other: Phone interview measuring health-related quality of life variables