Streptococcus InfectionSTREPTO-FASTNCT03976024
Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis Mono- or Multi-microbial Streptococcus Beta-haemolytic
A study testing DHBN-FN arm in people with Streptococcus Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the study is to evaluate streptococcal carriage by swab, pharyngeal, anal and perineal in patients with DHBN-FN, in the entourage living under the same roof as well as patients with erysipelas The main hypothesis is the major role of chronic porting of patients and entourage in DHBN-FN to SBH. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Infection
- What is being tested?
- DHBN-FN arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 1 Nov 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient:
- Major patient hospitalized for a DHBN-FN or erysipelas (clinical diagnosis determined at the entrance).
- Signed informed consent.
- Case contact
- person of major age living under the same roof as a patient who has had a DHBN-FN.
- Signed informed consent
Who cannot join
- Patient:
- Minor patient
- Immunosuppressed patient: active hematology, poorly controlled HIV, neutropenia (PNN <1000 / mm3).
- Patient under guardianship or curatorship
- Patient deprived of liberty by judicial or administrative decision
- Patient not affiliated to a social security scheme and not a beneficiary of such a scheme
Show all 11Show fewer
- Case contact
- Minor person
- Person under tutorship or curatorship
- Person deprived of liberty by judicial or administrative decision
- Person not affiliated with a social security
Trial locations and contacts
1 site in 1 country.
France1 site
Henri Mondor Hospital-AP-HP
Créteil, 94000
Olivier CHOSIDOW, pROFESSOR
Camille HUA, Doctor
About this study
Official title: Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis (DHBN-FN) Mono- or Multi-microbial Streptococcus Beta-haemolytic: Study of Carriage in Patients and Their Entourage
The aim of the study is to evaluate streptococcal carriage by swab, pharyngeal, anal and perineal in patients with DHBN-FN, in the entourage living under the same roof as well as patients with erysipelas
The main hypothesis is the major role of chronic porting of patients and entourage in DHBN-FN to SBH.
Read more
Indeed, the chronic pharyngeal / anal / perineal carriage could be a gateway following a transient bacteremia for a DHBN-FN.
The transmission of germs from the surrounding to the patient plays a major role:
At the gateway level in the case of exogenous DHBN-FN At the origin of chronic carriage in the case of endogenous DHBN-FN Transmission of germs from the patient to the surrounding area also plays an important role in increasing the risk of invasive SBH infections in the surrounding area.
- Conditions
- Streptococcus Infection
- Being tested
- DHBN-FN arm, Control arm (Erysipelas)
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHBN-FN armOther
DHBN-FN will be evaluated by pharyngeal swab, anal and perineal. If the family accepts, the carriage of streptococcus in persons living under the same roof as patients with DHBN-FN will be evaluated by pharyngeal, anal and perineal swab in consultation. These swabs will be made within 10 days of diagnosis of DHBN-FN of the index
Control arm (Erysipelas)Other
The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0 (admission).
| Study group | Role | What they receive |
|---|---|---|
| DHBN-FN arm | Experimental | Recruitment is planned in traditional hospitalization for DHBN-FN patients. Evaluation of streptococcal carriage by swab, pharyngeal, anal and perineal in patients hospitalized for a DHBN-FN at the end of hospitalization and 1 month after discharge from hospital during the reassessment consultation. Swabs made by the dermatologist.
The carriage of streptococcus in patients living under the same roof as patients with DHBN-FN will be evaluated by pharyngeal swab, anal and perineal. If the family accepts, the carriage of streptococcus in persons living under the same roof as patients with DHBN-FN will be evaluated by pharyngeal, anal and perineal swab in consultation. These swabs will be made within 10 days of diagnosis of DHBN-FN of the index Receives: Other: DHBN-FN arm |
| Control arm (Erysipelas) | Active comparator | Recruitment is planned in traditional hospitalization for patients with erysipelas.
The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0 (admission). Receives: Other: Control arm (Erysipelas) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of beta-hemolytic streptococcus in patients with DHBN-FN
Evaluation of streptococcal carriage by swab, pharyngeal, anal and perineal in patients hospitalized for a DHBN-FN . Swabs made by the dermatologist. The detection of beta-hemolytic streptococcus will be made by culture
Measured: Day 0
Rate of beta-hemolytic streptococcus in patients with DHBN-FN
Evaluation of streptococcal carriage by swab, pharyngeal, anal and perineal in patients hospitalized for a DHBN-FN . Swabs made by the dermatologist. The detection of beta-hemolytic streptococcus will be made by culture
Measured: 1 month after hospitalization discharge
Rate of beta-hemolytic streptococcus in patients with DHBN-FN
Evaluation of streptococcal carriage by swab, pharyngeal, anal and perineal in patients hospitalized for a DHBN-FN . Swabs made by the dermatologist. The detection of beta-hemolytic streptococcus will be made by culture
Measured: Day 30
Secondary outcomes (5)
Prevalence of SBH carriage at the time of diagnosis
Measured: Day 0, Day 10
Sites of SBH carriage at the time of diagnosis
Measured: Day 0, Day 10
Rate of beta-hemolytic streptococcus in patients with erysipelas
The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0.
Measured: Day 0
Rate of beta-hemolytic streptococcus in patients living under the same roof as patients with DHBN-FN
The carriage of streptococcus in persons living under the same roof as patients with DHBN-FN will be evaluated by pharyngeal, anal and perineal swab in consultation. These swabs will be made within 10 days of diagnosis of DHBN-FN of the index.
Measured: Up to 10 Days
Main factors of streptococcal virulence
Analyze the main factors of streptococcal virulence by Streptococcal genome sequencing
Measured: Day 0, Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Sep 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier CHOSODOW, Professor, Principal investigator, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976024
- Sponsor's protocol ID
- APHP180348
- Acronym
- STREPTO-FAST
- Status last verified
- Dec 2019
- First submitted
- 15 Mar 2019
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis (DHBN-FN) Mono- or Multi-microbial Streptococcus Beta-haemolytic: Study of Carriage in Patients and Their Entourage
- ClinicalTrials.gov ID
- NCT03976024
- Acronym / sponsor ID
- STREPTO-FAST / APHP180348
- Conditions
- Streptococcus Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 5 Jun 2019 (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.
The aim of the study is to evaluate streptococcal carriage by swab, pharyngeal, anal and perineal in patients with DHBN-FN, in the entourage living under the same roof as well as patients with erysipelas
The main hypothesis is the major role of chronic porting of patients and entourage in DHBN-FN to SBH.
Indeed, the chronic pharyngeal / anal / perineal carriage could be a gateway following a transient bacteremia for a DHBN-FN.
The transmission of germs from the surrounding to the patient plays a major role:
At the gateway level in the case of exogenous DHBN-FN At the origin of chronic carriage in the case of endogenous DHBN-FN Transmission of germs from the patient to the surrounding area also plays an important role in increasing the risk of invasive SBH infections in the surrounding area.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHBN-FN arm | Experimental | Other: DHBN-FN armRecruitment is planned in traditional hospitalization for DHBN-FN patients. Evaluation of streptococcal carriage by swab, pharyngeal, anal and perineal in patients hospitalized for a DHBN-FN at the end of hospitalization and 1 month after discharge from hospital during the reassessment consultation. Swabs made by the dermatologist. The carriage of streptococcus in patients living under the same roof as patients with DHBN-FN will be evaluated by pharyngeal swab, anal and perineal. If the family accepts, the carriage of streptococcus in persons living under the same roof as patients with DHBN-FN will be evaluated by pharyngeal, anal and perineal swab in consultation. These swabs will be made within 10 days of diagnosis of DHBN-FN of the index |
| Control arm (Erysipelas) | Active comparator | Other: Control arm (Erysipelas)Recruitment is planned in traditional hospitalization for patients with erysipelas. The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0 (admission). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient:
- Major patient hospitalized for a DHBN-FN or erysipelas (clinical diagnosis determined at the entrance).
- Signed informed consent.
- Case contact
- person of major age living under the same roof as a patient who has had a DHBN-FN.
Key exclusion criteria (11 listed)
- Patient:
- Minor patient
- Immunosuppressed patient: active hematology, poorly controlled HIV, neutropenia (PNN <1000 / mm3).
- Patient under guardianship or curatorship
- Patient deprived of liberty by judicial or administrative decision
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 |
|---|---|---|
| DHBN-FN armDHBN-FN will be evaluated by pharyngeal swab, anal and perineal. If the family accepts, the carriage of streptococcus in persons living under the same roof as patients with DHBN-FN will be evaluated by pharyngeal, anal and perineal swab in consultation. These swabs will be made within 10 days of diagnosis of DHBN-FN of the index | Other | DHBN-FN arm |
| Control arm (Erysipelas)The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0 (admission). | Other | Control arm (Erysipelas) |
Primary outcome
Rate of beta-hemolytic streptococcus in patients with DHBN-FN
Time frame: Day 0
Evaluation of streptococcal carriage by swab, pharyngeal, anal and perineal in patients hospitalized for a DHBN-FN . Swabs made by the dermatologist. The detection of beta-hemolytic streptococcus will be made by culture
Rate of beta-hemolytic streptococcus in patients with DHBN-FN
Time frame: 1 month after hospitalization discharge
Evaluation of streptococcal carriage by swab, pharyngeal, anal and perineal in patients hospitalized for a DHBN-FN . Swabs made by the dermatologist. The detection of beta-hemolytic streptococcus will be made by culture
Rate of beta-hemolytic streptococcus in patients with DHBN-FN
Time frame: Day 30
Evaluation of streptococcal carriage by swab, pharyngeal, anal and perineal in patients hospitalized for a DHBN-FN . Swabs made by the dermatologist. The detection of beta-hemolytic streptococcus will be made by culture
5 secondary outcomes
Prevalence of SBH carriage at the time of diagnosis
Time frame: Day 0, Day 10
Sites of SBH carriage at the time of diagnosis
Time frame: Day 0, Day 10
Rate of beta-hemolytic streptococcus in patients with erysipelas
Time frame: Day 0
Rate of beta-hemolytic streptococcus in patients living under the same roof as patients with DHBN-FN
Time frame: Up to 10 Days
Main factors of streptococcal virulence
Time frame: Day 0, Day 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Individual participant dataSharing planned: No
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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.
Olivier CHOSODOW, Professor principal investigator
Henri Mondor University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHBN-FN arm in people with Streptococcus Infection, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 11 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 20 May 2020. 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 Olivier CHOSIDOW, Professor (+33(1)49812500, olivier.chosidow@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of beta-hemolytic streptococcus in patients with DHBN-FN (time frame: Day 0). 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?
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 20 May 2020.