An interventional study of DHBN-FN arm and Control arm (Erysipelas) in Streptococcus Infection, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-20.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Prevention
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.
146 studies on the registry are indexed under Streptococcal Infections; 14 are open to participants now.
This study's planned enrollment of 100 is below the median of 270 across 106 interventional studies indexed under Streptococcal Infections.
Browse Streptococcal Infections studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.
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Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: DHBN-FN arm
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).
Other: Control arm (Erysipelas)
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
The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0 (admission).
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
Time frame: 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
Time frame: 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
Time frame: Day 30
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
The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0.
Time frame: 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.
Time frame: Up to 10 Days
Main factors of streptococcal virulence
Analyze the main factors of streptococcal virulence by Streptococcal genome sequencing
Time frame: Day 0, Day 10
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2020; primary completion for Oct 2020, 1 month later.
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This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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