Cervical Necrotizing FasciitisNCT02847234
Factors Associated With Complications of Cervical Necrotizing Fasciitis
An observational study of Cervical Necrotizing Fasciitis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Cervical necrotizing fasciitis (CNF) is a rare but severe complication of pharyngeal or dental infections. The infection can rapidly descend into the mediastinum and lead to a life-threatening prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Necrotizing Fasciitis
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Dec 2016
- 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: Patient admitted in ICU for management of cervical necrotizing fasciitis
Who may be able to join
- Patient admitted in ICU for management of cervical necrotizing fasciitis between 2005 and 2016.
Who cannot join
- Patients admitted in ICU for management of cervical abscess without cervical necrotizing fasciitis
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Intensive Care unit, Edouard Herriot Hospital
Lyon, 69003
Myrtille Fouché, resident, (0)613782554 ext. +33, myrtille_fouche@hotmail.com
Thomas Rimmelé, MD, PHD, (0)4 72 11 69 88 ext. +33, thomas.rimmele@chu-lyon.fr
About this study
Cervical necrotizing fasciitis (CNF) is a rare but severe complication of pharyngeal or dental infections. The infection can rapidly descend into the mediastinum and lead to a life-threatening prognosis. Treatment consists of a multidisciplinary approach in intensive care with radiologist and with early and repeated surgical debridement. Anti-inflammatory drugs have been incriminated by authors in the development of necrotizing fasciitis. Recently, a single-center study demonstrated that pharyngeal source of CNF and oral glucocorticoid intake before admission was associated with the occurrence of mediastinitis.
The aim of the study is to assess the incidence and factors associated with CNF complications, in particular mediastinitis. Secondary outcome is to describe patient characteristics, medical and surgical management.
Methods: A retrospective, observational, non-interventional multicentre study is conducted in nine intensive care units in France from January 2005 to December 2016.
- Conditions
- Cervical Necrotizing Fasciitis
- Keywords
- Cervical necrotizing fasciitis, mediastinitis
- Medical subject headings
- Mediastinitis
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of mediastinitis
Computed tomography (CT) is performed at admission. Mediastinitis is described on CT finding.
Measured: At the entry in ICU (Day 1)
Secondary outcomes (1)
factors associated with mediastinitis
Computed tomography (CT) is performed at admission. Mediastinitis is described on CT finding.
Measured: At the entry in ICU (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Necrotizing FasciitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Rimmelé, MD PhD, Principal investigator, Intensive Care unit, Edouard Herriot Hospital, 69003 Lyon, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847234
- Sponsor's protocol ID
- 69HCL16_0500
- Status last verified
- Jul 2016
- First submitted
- 25 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Complications of Cervical Necrotizing Fasciitis
- ClinicalTrials.gov ID
- NCT02847234
- Acronym / sponsor ID
- 69HCL16_0500
- Conditions
- Cervical Necrotizing Fasciitis
- Keywords
- Cervical necrotizing fasciitis, mediastinitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 28 Jul 2016 (estimated)
- 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.
Cervical necrotizing fasciitis (CNF) is a rare but severe complication of pharyngeal or dental infections. The infection can rapidly descend into the mediastinum and lead to a life-threatening prognosis. Treatment consists of a multidisciplinary approach in intensive care with radiologist and with early and repeated surgical debridement. Anti-inflammatory drugs have been incriminated by authors in the development of necrotizing fasciitis. Recently, a single-center study demonstrated that pharyngeal source of CNF and oral glucocorticoid intake before admission was associated with the occurrence of mediastinitis.
The aim of the study is to assess the incidence and factors associated with CNF complications, in particular mediastinitis. Secondary outcome is to describe patient characteristics, medical and surgical management.
Methods: A retrospective, observational, non-interventional multicentre study is conducted in nine intensive care units in France from January 2005 to December 2016.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted in ICU for management of cervical necrotizing fasciitis
Key inclusion criteria (1 listed)
- Patient admitted in ICU for management of cervical necrotizing fasciitis between 2005 and 2016.
Key exclusion criteria (2 listed)
- Patients admitted in ICU for management of cervical abscess without cervical necrotizing fasciitis
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of mediastinitis
Time frame: At the entry in ICU (Day 1)
Computed tomography (CT) is performed at admission. Mediastinitis is described on CT finding.
1 secondary outcome
factors associated with mediastinitis
Time frame: At the entry in ICU (Day 1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
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.
Thomas Rimmelé, MD PhD principal investigator
Intensive Care unit, Edouard Herriot Hospital, 69003 Lyon, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Necrotizing Fasciitis, run by Hospices Civils de Lyon at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Rimmelé, MD PhD ((0)4 72 11 69 88 ext. +33, thomas.rimmele@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of mediastinitis (time frame: At the entry in ICU (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2016.