Purpura FulminanshOPeFULNCT03216577
Outcomes of Purpura FULminans in Adults - The hOPeFUL Study
An observational study of Purpura Fulminans, run by Henri Mondor University Hospital at 26 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Purpura Fulminans
- What is being tested?
- Phone interview measuring health-related quality of life variables
- How many people
- 74 participants
- Where
- 26 sitesFrance
- Study dates
- 27 Jul 2017to 8 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Patients admitted in the intensive care unit between 2010 and 2016 for an infectious purpura fulminans and discharged alive
Who cannot join
- Age < 18 years
- Non infectious purpura
- Infective endocarditis
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
Aulnay sous Bois Hospital
Aulnay-sous-Bois, 86000
Caen University Hospital
Caen, 14118
Chartres Hospital
Chartres, 28000
Louis Mourier Hospital
Colombes, 92700
Henri Mondor Hospital
Créteil, 94010
Grenoble University Hospital
Grenoble, 38100
La Roche sur Yon Hospital
La Roche-sur-Yon, 85925
Versailles Hospital
Le Chesnay, 78150
Le Havre Hospital
Le Havre, 76600
Lilles University Hospital
Lilles, 59000
Edouard Herriot Hospital
Lyon, 69003
Melun Hospital
Melun, 77000
Nice University Hospital
Nice, 6003
Orléans Hospital
Orléans, 45000
Saint Louis Hospital
Paris, 75010
Saint-Antoine Hospital
Paris, 75012
Pitié-Salpétrière Hospital
Paris, 75013
Cochin Hospital
Paris, 75014
Bichat University Hospital
Paris, 75018
Poissy Hospital
Poissy, 78300
Poitiers University Hospital
Poitiers, 86000
Clinique Gallien
Quincy-sous-Sénart, 91480
Reims University Hospital
Reims, 51100
Rennes University Hospital
Rennes, 35000
Roubaix Hospital
Roubaix, 59100
Tours University Hospital
Tours, 37000
About this study
Official title: Short and Long-term Outcomes of Purpura Fulminans in Adults
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.
Read the 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).
- Conditions
- Purpura Fulminans
- Being tested
- Phone interview measuring health-related quality of life variables
- Keywords
- health-related quality of life
- Medical subject headings
- Purpura Fulminans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone interview measuring health-related quality of life variablesOther
A phone interview will be conducted by a dedicated nurse who will be blinded to the exposed/non-exposed status of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Exposed to purpura fulminans | Patients who were admitted in the intensive care unit and survived a purpura fulminans episode Receives: Other: Phone interview measuring health-related quality of life variables | |
| 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. Receives: Other: Phone interview measuring health-related quality of life variables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
factors associated with hospital mortality (and rate of amputation in the hospital) will be identified using a polytomous logistic regression model
Measured: 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
Measured: 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
Measured: Within 6 years of hospital discharge
Secondary outcomes (6)
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
Measured: Within 6 years of hospital discharge
Activity of daily living (ADL score)
This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Within 6 years of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start27 Jul 2017
- Primary completion8 Mar 2018
- Study completion8 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Purpura FulminansStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henri Mondor University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France
- Responsible party
- Principal investigator, Nicolas de Prost, Henri Mondor University Hospital
- Investigators
- Nicolas de Prost, MD, PhD, Principal investigator, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216577
- Sponsor's protocol ID
- hOPeFUL
- Acronym
- hOPeFUL
- Status last verified
- Mar 2018
- First submitted
- 7 Jul 2017
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 1992958Lerolle 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.
PubMed 23924269Contou 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.
PubMed 30335142Contou 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.
PubMed 30128591
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long-term Outcomes of Purpura Fulminans in Adults
- ClinicalTrials.gov ID
- NCT03216577
- Acronym / sponsor ID
- hOPeFUL / hOPeFUL
- Conditions
- Purpura Fulminans
- Keywords
- health-related quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Henri Mondor University HospitalUniversity, hospital or other
- Collaborators
- Fondation de France
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 8 Mar 2018 (actual)
- Study completion
- 8 Mar 2018 (actual)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed to purpura fulminans | – | Other: Phone interview measuring health-related quality of life variablesPatients who were admitted in the intensive care unit and survived a purpura fulminans episode |
| Non-exposed to purpura fulminans | – | Other: Phone interview measuring health-related quality of life variablesPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Patients admitted in the intensive care unit between 2010 and 2016 for an infectious purpura fulminans and discharged alive
Key exclusion criteria (3 listed)
- Age < 18 years
- Non infectious purpura
- Infective endocarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone interview measuring health-related quality of life variablesA phone interview will be conducted by a dedicated nurse who will be blinded to the exposed/non-exposed status of the patient. | Other | Exposed to purpura fulminans, Non-exposed to purpura fulminans |
Primary outcome
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
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
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
6 secondary outcomes
Mental component score of the SF-36 score
Time frame: Within 6 years of hospital discharge
Activity of daily living (ADL score)
Time frame: Within 6 years of hospital discharge
Hospital anxiety and depression scale
Time frame: Within 6 years of hospital discharge
Impact of Event Scale
Time frame: Within 6 years of hospital discharge
Physical dimension scale of the SF-36 questionnaire
Time frame: Within 6 years of hospital discharge
Mental component score of the SF-36 score
Time frame: Within 6 years of hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Results publication: PubMed 1992958Giraud 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.
- Results publication: PubMed 23924269Lerolle 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.
- Derived from this study: PubMed 30335142Contou 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.
- Derived from this study: PubMed 30128591Contou 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas de Prost, MD, PhD principal investigator
Henri Mondor University Hospital
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Purpura Fulminans, run by Henri Mondor University Hospital at 26 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital mortality (time frame: day 60). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03216577, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.