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| Name | Class |
|---|---|
| Fondation de France | OTHER |
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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.
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of PF have been well studied in the pediatric setting, the amount of available data for adult PF are scarce, often outdated and mainly limited to patients with meningococcal infections.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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed to purpura fulminans | Patients who were admitted in the intensive care unit and survived a purpura fulminans episode |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phone interview measuring health-related quality of life variables | Other | A phone interview will be conducted by a dedicated nurse who will be blinded to the exposed/non-exposed status of the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital mortality | factors associated with hospital mortality (and rate of amputation in the hospital) will be identified using a polytomous logistic regression model | day 60 |
| Rate of amputation in the hospital; | factors associated with rate of amputation in the hospital (and hospital mortality) will be identified using a polytomous logistic regression model | day 60 |
| Long-term outcome measure: Physical dimension scale of the SF-36 questionnaire | This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans | Within 6 years of hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Mental component score of the SF-36 score | This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans | Within 6 years of hospital discharge |
| Activity of daily living (ADL score) |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas de Prost, MD, PhD | Henri Mondor University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aulnay sous Bois Hospital | Aulnay-sous-Bois | 86000 | France | |||
| Caen University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1992958 | Result | Giraud T, Dhainaut JF, Schremmer B, Regnier B, Desjars P, Loirat P, Journois D, Lanore JJ. Adult overwhelming meningococcal purpura. A study of 35 cases, 1977-1989. Arch Intern Med. 1991 Feb;151(2):310-6. | |
| 23924269 | Result | Lerolle N, Carlotti A, Melican K, Aubey F, Pierrot M, Diehl JL, Caille V, Hekimian G, Gandrille S, Mandet C, Bruneval P, Dumenil G, Borgel D. Assessment of the interplay between blood and skin vascular abnormalities in adult purpura fulminans. Am J Respir Crit Care Med. 2013 Sep 15;188(6):684-92. doi: 10.1164/rccm.201302-0228OC. |
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This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans |
| Within 6 years of hospital discharge |
| Hospital anxiety and depression scale | This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans | Within 6 years of hospital discharge |
| Impact of Event Scale | This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans | Within 6 years of hospital discharge |
| Physical dimension scale of the SF-36 questionnaire | This variable will be compared between patients with purpura fulminans who were and those who were not amputated | Within 6 years of hospital discharge |
| Mental component score of the SF-36 score | This variable will be compared between patients with purpura fulminans who were and those who were not amputated | Within 6 years of hospital discharge |
| Caen |
| 14118 |
| France |
| Chartres Hospital | Chartres | 28000 | France |
| Louis Mourier Hospital | Colombes | 92700 | France |
| Henri Mondor Hospital | Créteil | 94010 | France |
| Grenoble University Hospital | Grenoble | 38100 | France |
| La Roche sur Yon Hospital | La Roche-sur-Yon | 85925 | France |
| Versailles Hospital | Le Chesnay | 78150 | France |
| Le Havre Hospital | Le Havre | 76600 | France |
| Lilles University Hospital | Lilles | 59000 | France |
| Edouard Herriot Hospital | Lyon | 69003 | France |
| Melun Hospital | Melun | 77000 | France |
| Nice University Hospital | Nice | 6003 | France |
| Orléans Hospital | Orléans | 45000 | France |
| Saint Louis Hospital | Paris | 75010 | France |
| Saint-Antoine Hospital | Paris | 75012 | France |
| Pitié-Salpétrière Hospital | Paris | 75013 | France |
| Cochin Hospital | Paris | 75014 | France |
| Bichat University Hospital | Paris | 75018 | France |
| Poissy Hospital | Poissy | 78300 | France |
| Poitiers University Hospital | Poitiers | 86000 | France |
| Clinique Gallien | Quincy-sous-Sénart | 91480 | France |
| Reims University Hospital | Reims | 51100 | France |
| Rennes University Hospital | Rennes | 35000 | France |
| Roubaix Hospital | Roubaix | 59100 | France |
| Tours University Hospital | Tours | 37000 | France |
| 30335142 | Derived | Contou D, Canoui-Poitrine F, Coudroy R, Preau S, Cour M, Barbier F, Terzi N, Schnell G, Galbois A, Zafrani L, Zuber B, Ehrmann S, Gelisse E, Colling D, Schmidt M, Jaber S, Conia A, Sonneville R, Colin G, Guerin L, Roux D, Jochmans S, Kentish-Barnes N, Audureau E, Layese R, Alves A, Ouedraogo R, Brun-Buisson C, Mekontso Dessap A, de Prost N; Hopeful Study Group. Long-term Quality of Life in Adult Patients Surviving Purpura Fulminans: An Exposed-Unexposed Multicenter Cohort Study. Clin Infect Dis. 2019 Jul 2;69(2):332-340. doi: 10.1093/cid/ciy901. |
| 30128591 | Derived | Contou D, Sonneville R, Canoui-Poitrine F, Colin G, Coudroy R, Pene F, Tadie JM, Cour M, Beduneau G, Marchalot A, Guerin L, Jochmans S, Ehrmann S, Terzi N, Preau S, Barbier F, Schnell G, Roux D, Leroy O, Pichereau C, Gelisse E, Zafrani L, Layese R, Brun-Buisson C, Mekontso Dessap A, de Prost N; Hopeful Study Group. Clinical spectrum and short-term outcome of adult patients with purpura fulminans: a French multicenter retrospective cohort study. Intensive Care Med. 2018 Sep;44(9):1502-1511. doi: 10.1007/s00134-018-5341-3. Epub 2018 Aug 20. |
| ID | Term |
|---|---|
| D055665 | Purpura Fulminans |
| ID | Term |
|---|---|
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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