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Outcomes of Purpura FULminans in Adults - The hOPeFUL Study (hOPeFUL)

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ClinicalTrials.gov Identifier: NCT03216577
Recruitment Status : Completed
First Posted : July 13, 2017
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
Fondation de France
Information provided by (Responsible Party):
Nicolas de Prost, Henri Mondor University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Purpura Fulminans Other: Phone interview measuring health-related quality of life variables

Detailed 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of PF have been well studied in the pediatric setting, the amount of available data for adult PF are scarce, often outdated and mainly limited to patients with meningococcal infections.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).

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Study Type : Observational
Actual Enrollment : 74 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Short and Long-term Outcomes of Purpura Fulminans in Adults
Actual Study Start Date : July 27, 2017
Actual Primary Completion Date : March 8, 2018
Actual Study Completion Date : March 8, 2018

Group/Cohort Intervention/treatment
Exposed to purpura fulminans
Patients who were admitted in the intensive care unit and survived a purpura fulminans episode
Other: Phone interview measuring health-related quality of life variables
A phone interview will be conducted by a dedicated nurse who will be blinded to the exposed/non-exposed status of the patient.

Non-exposed to purpura fulminans
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.
Other: Phone interview measuring health-related quality of life variables
A phone interview will be conducted by a dedicated nurse who will be blinded to the exposed/non-exposed status of the patient.




Primary Outcome Measures :
  1. Hospital mortality [ Time Frame: day 60 ]
    factors associated with hospital mortality (and rate of amputation in the hospital) will be identified using a polytomous logistic regression model

  2. Rate of amputation in the hospital; [ Time Frame: day 60 ]
    factors associated with rate of amputation in the hospital (and hospital mortality) will be identified using a polytomous logistic regression model

  3. Long-term outcome measure: Physical dimension scale of the SF-36 questionnaire [ Time Frame: Within 6 years of hospital discharge ]
    This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans


Secondary Outcome Measures :
  1. Mental component score of the SF-36 score [ Time Frame: Within 6 years of hospital discharge ]
    This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans

  2. Activity of daily living (ADL score) [ Time Frame: Within 6 years of hospital discharge ]
    This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans

  3. Hospital anxiety and depression scale [ Time Frame: Within 6 years of hospital discharge ]
    This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans

  4. Impact of Event Scale [ Time Frame: Within 6 years of hospital discharge ]
    This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans

  5. Physical dimension scale of the SF-36 questionnaire [ Time Frame: Within 6 years of hospital discharge ]
    This variable will be compared between patients with purpura fulminans who were and those who were not amputated

  6. Mental component score of the SF-36 score [ Time Frame: Within 6 years of hospital discharge ]
    This variable will be compared between patients with purpura fulminans who were and those who were not amputated



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted in the intensive care unit between 2010 and 2016 for an infectious purpura fulminans (cases/exposed patients) and discharged alive will be matched (gender, age and SAPS II score) to patients admitted during the same time frame for a septic shock non-related to purpura fulminans (controls/non-exposed pâtients).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216577


Locations
Show Show 26 study locations
Sponsors and Collaborators
Henri Mondor University Hospital
Fondation de France
Investigators
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Principal Investigator: Nicolas de Prost, MD, PhD Henri Mondor Hospital
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nicolas de Prost, MD, PhD, Henri Mondor University Hospital
ClinicalTrials.gov Identifier: NCT03216577    
Other Study ID Numbers: hOPeFUL
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nicolas de Prost, Henri Mondor University Hospital:
health-related quality of life
Additional relevant MeSH terms:
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Purpura
Purpura Fulminans
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations