Necrotizing FasciitisNCT02169128
Severe Soft Tissue Infections: Perspectives of Patients and Significant Others
An observational study of Necrotizing Fasciitis, run by Göteborg University at 3 sites in 2 countries.
Trial summary
Severe necrotizing soft tissue infection (NSTI), including necrotizing fasciitis, is a life threatening infection that spreads quickly to cutis, sub-cutis, fasciae and muscles. Approximately 40% of all patients with infections caused by S. Pyogenes develop a streptococcal toxic-shock syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotizing Fasciitis
- How many people
- 30 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2014to Dec 2019
- 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 treated for necrotizing fasciitis at the three study sites
Who may be able to join
- Patients diagnosed with necrotizing fasciitis and their significant others
- Age above 18 yrs
Who cannot join
- Persons with dementia or severe psychiatric illness
- Persons that do not master the Scandinavian language
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska University hospital
Gothenburg, 416 85
Sven-Egron Thörn, MD, ass prof, +46313434000, sven-egron.thorn@vgregion.se
Annette Erichsen Andersson, RN, PhD
- Recruiting
Karolinska Universitetssjukhuset
Solna, 171 64
Folke Lind, MD, PhD, +46851775557, folke.lind@karolinska.se
Ann-Mari Fagerdahl, RN, PhD
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 4131
Ingrid Egerod, RN, prof, ingrid.egerod@regionh.dk
Martin Bruun Madsen, MD
About this study
Severe necrotizing soft tissue infection (NSTI), including necrotizing fasciitis, is a life threatening infection that spreads quickly to cutis, sub-cutis, fasciae and muscles. Approximately 40% of all patients with infections caused by S. Pyogenes develop a streptococcal toxic-shock syndrome. In these cases the mortality rates exceed 40% in spite of adequate treatment with antimicrobials. Due to the rapid progress, the extensive damage on soft tissues and high risk of death, the microbes are called "flesh-eating bacteria". The present study is a spin-off of the larger EU funded INFECT study, looking at the experiences of patient and family to understand the impact on every day life. The present prospective mixed methods study has the potential to provide important knowledge regarding the occurrence of early signs and symptoms of NSTI, quality of life 6 and 24 months after diagnosis, and how the care and treatment can be optimized and organized in a person/patient and family centered way. The study also aims at validate the SF 36 questionnaire for this group of patients.
- Conditions
- Necrotizing Fasciitis
- Medical subject headings
- Fasciitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients and their significant others | Patients affected by necrotizing fasciitis and their significant others |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Quantitative - health related quality of life Qualitative - patient experience
Measured: 6 months
Quality of life
Quantitative - health related quality of life Qualitative - patient experience
Measured: 24 months
Secondary outcomes (2)
Quality of life of significant others
Quantitative - health related quality of life Qualitative - experience of significant others
Measured: 6 months
Quality of life of significant others
Quantitative - health related quality of life Qualitative - experience of significant others
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing FasciitisStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Karolinska Institutet, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
- Investigators
- Sven-Egron Thörn, MD, ass prof, Study director, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169128
- Sponsor's protocol ID
- SSTI
- Status last verified
- Aug 2018
- First submitted
- 19 Jun 2014
- Last updated
- 14 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Soft Tissue Infections: Perspectives of Patients and Significant Others
- ClinicalTrials.gov ID
- NCT02169128
- Acronym / sponsor ID
- SSTI
- Conditions
- Necrotizing Fasciitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Karolinska Institutet, Copenhagen University Hospital, Rigshospitalet
- Study start
- Jan 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 Jun 2014 (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.
Severe necrotizing soft tissue infection (NSTI), including necrotizing fasciitis, is a life threatening infection that spreads quickly to cutis, sub-cutis, fasciae and muscles. Approximately 40% of all patients with infections caused by S. Pyogenes develop a streptococcal toxic-shock syndrome. In these cases the mortality rates exceed 40% in spite of adequate treatment with antimicrobials. Due to the rapid progress, the extensive damage on soft tissues and high risk of death, the microbes are called "flesh-eating bacteria". The present study is a spin-off of the larger EU funded INFECT study, looking at the experiences of patient and family to understand the impact on every day life. The present prospective mixed methods study has the potential to provide important knowledge regarding the occurrence of early signs and symptoms of NSTI, quality of life 6 and 24 months after diagnosis, and how the care and treatment can be optimized and organized in a person/patient and family centered way. The study also aims at validate the SF 36 questionnaire for this group of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients and their significant others | – | –Patients affected by necrotizing fasciitis and their significant others |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for necrotizing fasciitis at the three study sites
Key inclusion criteria (2 listed)
- Patients diagnosed with necrotizing fasciitis and their significant others
- Age above 18 yrs
Key exclusion criteria (2 listed)
- Persons with dementia or severe psychiatric illness
- Persons that do not master the Scandinavian language
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
Quality of life
Time frame: 6 months
Quantitative - health related quality of life Qualitative - patient experience
Quality of life
Time frame: 24 months
Quantitative - health related quality of life Qualitative - patient experience
2 secondary outcomes
Quality of life of significant others
Time frame: 6 months
Quality of life of significant others
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
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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.
Sven-Egron Thörn, MD, ass prof study director
Sahlgrenska University Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Fasciitis, run by Göteborg University at 3 sites in 2 countries.
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 2 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 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden, Denmark. 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 Annette Erichsen Andersson, RN, PhD (+46737250458, annette.erichsen.andersson@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 6 months). The study lists 2 primary outcomes in all. 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 14 Aug 2018.