Clinical trial NCT03216577: Outcomes of Purpura FULminans in Adults - The hOPeFUL Study
Official title: Short and Long-term Outcomes of Purpura Fulminans in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Purpura Fulminans
Keywords: health-related quality of life
Lead sponsor: Henri Mondor University Hospital
Sponsor class: OTHER
Collaborators: name: Fondation de France
First posted: 2017-07-13
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

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).

Eligibility 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

Primary outcomes:
measure: Hospital mortality
timeFrame: day 60
measure: Rate of amputation in the hospital;
timeFrame: day 60
measure: Long-term outcome measure: Physical dimension scale of the SF-36 questionnaire
timeFrame: Within 6 years of hospital discharge
Secondary outcomes:
measure: Mental component score of the SF-36 score
timeFrame: Within 6 years of hospital discharge
measure: Activity of daily living (ADL score)
timeFrame: Within 6 years of hospital discharge
measure: Hospital anxiety and depression scale
timeFrame: Within 6 years of hospital discharge
measure: Impact of Event Scale
timeFrame: Within 6 years of hospital discharge
measure: Physical dimension scale of the SF-36 questionnaire
timeFrame: Within 6 years of hospital discharge
measure: Mental component score of the SF-36 score
timeFrame: Within 6 years of hospital discharge
Other outcomes:
Locations:
city: Aulnay-sous-Bois
country: France
facility: Aulnay sous Bois Hospital
city: Caen
country: France
facility: Caen University Hospital
city: Chartres
country: France
facility: Chartres Hospital
city: Colombes
country: France
facility: Louis Mourier Hospital
city: Créteil
country: France
facility: Henri Mondor Hospital
city: Grenoble
country: France
facility: Grenoble University Hospital
city: La Roche sur Yon
country: France
facility: La Roche sur Yon Hospital
city: Le Chesnay
country: France
facility: Versailles Hospital
city: Le Havre
country: France
facility: Le Havre Hospital
city: Lilles
country: France
facility: Lilles University Hospital
city: Lyon
country: France
facility: Edouard Herriot Hospital
city: Melun
country: France
facility: Melun Hospital
city: Nice
country: France
facility: Nice University Hospital
city: Orléans
country: France
facility: Orléans Hospital
city: Paris
country: France
facility: Saint Louis Hospital
city: Paris
country: France
facility: Saint-Antoine Hospital
city: Paris
country: France
facility: Pitié-Salpétrière Hospital
city: Paris
country: France
facility: Cochin Hospital
city: Paris
country: France
facility: Bichat University Hospital
city: Poissy
country: France
facility: Poissy Hospital
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Quincy-sous-Sénart
country: France
facility: Clinique Gallien
city: Reims
country: France
facility: Reims University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Roubaix
country: France
facility: Roubaix Hospital
city: Tours
country: France
facility: Tours University Hospital
Study officials:
affiliation: Henri Mondor University Hospital
name: Nicolas de Prost, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.