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

March 8, 2018 updated by: Nicolas de Prost, Henri Mondor University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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of PF have been well studied in the pediatric setting, the amount of available data for adult PF are scarce, often outdated and mainly limited to patients with meningococcal infections.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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aulnay-sous-Bois, France, 86000
        • Aulnay sous Bois Hospital
      • Caen, France, 14118
        • Caen University Hospital
      • Chartres, France, 28000
        • Chartres Hospital
      • Colombes, France, 92700
        • Louis Mourier Hospital
      • Créteil, France, 94010
        • Henri Mondor Hospital
      • Grenoble, France, 38100
        • Grenoble University Hospital
      • La Roche sur Yon, France, 85925
        • La Roche Sur Yon Hospital
      • Le Chesnay, France, 78150
        • Versailles Hospital
      • Le Havre, France, 76600
        • Le Havre Hospital
      • Lilles, France, 59000
        • Lilles University Hospital
      • Lyon, France, 69003
        • Edouard Herriot Hospital
      • Melun, France, 77000
        • Melun Hospital
      • Nice, France, 6003
        • Nice University Hospital
      • Orléans, France, 45000
        • Orléans Hospital
      • Paris, France, 75014
        • Cochin Hospital
      • Paris, France, 75013
        • Pitié-Salpêtrière Hospital
      • Paris, France, 75010
        • Saint Louis Hospital
      • Paris, France, 75012
        • Saint-Antoine Hospital
      • Paris, France, 75018
        • Bichat University Hospital
      • Poissy, France, 78300
        • Poissy Hospital
      • Poitiers, France, 86000
        • Poitiers University Hospital
      • Quincy-sous-Sénart, France, 91480
        • Clinique Gallien
      • Reims, France, 51100
        • Reims University Hospital
      • Rennes, France, 35000
        • Rennes University Hospital
      • Roubaix, France, 59100
        • Roubaix hospital
      • Tours, France, 37000
        • Tours University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
day 60
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
day 60
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
Within 6 years of hospital discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Within 6 years of hospital discharge
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
Within 6 years of hospital discharge
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
Within 6 years of hospital discharge
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
Within 6 years of hospital discharge
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
Within 6 years of hospital discharge
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
Within 6 years of hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henri Mondor University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fondation de France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicolas de Prost, MD, PhD, Henri Mondor University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 8, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 8, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • hOPeFUL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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