Invasive GAS InfectionStreptoPediaNCT02010294
Invasive Group A Streptococcus (GAS) Infection in Children: Bacterial Virulence Factors and Detection of Host Immunological and/or Genetic Factors of Predisposition to Infections
An observational study of Invasive GAS Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective of the study is to characterize the virulence factors of SGA and identify immunological and / or genetic factors predisposing to infections in children hospitalized with invasive GAS infection. Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Invasive GAS Infection
- What is being tested?
- DNA samples, GAS strains
- How many people
- 223 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2014to 20 Jul 2018
- 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 1 month to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children hospitalized for invasive or non invasive GAS infection
Who may be able to join
- Age ≥ 1 month to <15 years at the time of inclusion
- Group 1 : Children hospitalized for invasive GAS infection
- Subgroup 1A ( N = 75 ): Children with invasive infection without known risk factor .
- Subgroup 1B (N = 75) : Children with invasive infection with known risk factor .
- GAS Invasive infections are defined by:
- Proved infection : Bacteriological isolation of S. pyogenes from a liquid or a normally sterile site, except from a blister of a simple erysipelas, without necrosis . This is sometimes associated with a shock with multiorgan failure (streptococcal toxic shock syndrome ( STSS )) b ) Probable infection :
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- . Bacteriological isolation of S. pyogenes from a normally non-sterile site ( eg skin, upper respiratory tract ) associated with extensive soft tissue necrosis
- . Bacteriological isolation of S. pyogenes a site or a biological sample usually non-sterile ( eg skin , upper respiratory tract ) associated with a evocative shock syndrome STSS and no other cause found .
- Contributing factors for invasive infection are defined by:
- cutaneous effraction (wounds , burn , chicken pox ), the use of corticosteroids or other treatment, immunosuppressive and recent surgery
- Group 2: non-invasive infection such as pharyngitis , tonsillitis, proctitis or skin infection diagnosed by a positive test for rapid diagnosis of GAS performed at the site of infection with a positive GAS culture.
Who cannot join
- Group 1: Children with a known immune deficiency unrelated to the risk factors described above.
- Group 2: Children with a known immune deficiency.
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of the study is to characterize the virulence factors of SGA and identify immunological and / or genetic factors predisposing to infections in children hospitalized with invasive GAS infection.
Read the detailed description
The group A streptococcus (GAS) or Streptococcus pyogenes is a strictly human pathogen , which can cause a wide variety of infections. These range from a simple asymptomatic carriage up to 20 % of children , or minor illnesses such as sore throat or impetigo, to severe conditions such as necrotizing fasciitis and toxic shock syndrome .
The pathophysiological mechanisms of invasive GAS infections are poorly understood. These mechanisms could involve not only virulence factors of the bacterium ( M protein determines the emm genotype , but also super- antigenic exotoxins SpeA , Spe C, Ssa, Sme z or other virulence genes , SilC , ... Sic ), but also in some cases, factors associated with host immunity in particular in the absence of risk factors for invasive skin infection such as cutaneous effraction ( wound , burn , chicken pox ) , corticosteroids or other immunosuppressive therapy and recent surgery .
The investigators assume that in some invasive GAS infections, especially in children without risk factors, Mendelian susceptibility to infection may be involved . This hypothesis could be tested by studying the molecular characteristics of strains isolated SGA and innate and adaptive immunity in children hospitalised for invasive GAS infection with or without identified risk factors for infection.
This study could not only lead to a better understanding of the pathophysiological mechanisms of invasive GAS infections but also to detect in children who underwent invasive GAS genetic susceptibility to infections requiring specific care . Finally, it could also identify specific strains of SGA or molecular profiles, whose detection in practice, lead to a suspicion of hereditary immune deficiency.
- Conditions
- Invasive GAS Infection
- Being tested
- DNA samples, GAS strains
- Keywords
- Invasive GAS infection, emm genotypes, Bacterial virulence factors, Mendelian susceptibility to infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA samples, GAS strainsGenetic
DNA samples,GAS strains
| Study group | Role | What they receive |
|---|---|---|
| Children hospitalized for invasive GAS infection | Children hospitalized for invasive GAS infection Receives: Genetic: DNA samples, GAS strains | |
| Children with non-invasive infection | Children with non-invasive infection such as pharyngitis, tonsillitis, proctitis or skin infection diagnosed by a positive test for rapid diagnosis of GAS performed at the site of infection with a positive GAS culture Receives: Genetic: DNA samples, GAS strains |
What is being measured
The primary outcome is the main question the study is designed to answer.
virulence factors of GAS
characterize the virulence factors of GAS
Measured: up to 3 years
Secondary outcomes (3)
Assess the frequency and type of hereditary immune deficiency or Mendelian susceptibility to infections associated with invasive GAS infections in children without risk factors
frequency and type of hereditary immune deficiency or Mendelian susceptibility to infections associated with invasive GAS infections
Measured: up to 3 years
describe and compare the GAS emm genotypes and virulence factors with the profiles of strains isolated with invasive GAS infection with known risk factors and with the profile of strains isolated with a non-invasive GAS infections
describe and compare the GAS emm genotypes and virulence factors profile of GAS associated with an inherited immune deficiency, or a Mendelian susceptibility to infection, with the profiles of strains isolated in children with invasive GAS infection with known risk factors (use of steroids, varicella, wounds…) and with the profile of strains isolated in children with a non-invasive GAS infections
Measured: up to 3 years
compare GAS emm genotypes and profiles of virulence strains responsible for invasive SGA infections with strains causing noninvasive infections
compare GAS emm genotypes and profiles of virulence strains responsible for invasive SGA infections with strains causing noninvasive infections
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study start10 Feb 2014
- Primary completion10 Feb 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive GAS 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Albert FAYE, MD, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010294
- Sponsor's protocol ID
- P120136
- Acronym
- StreptoPedia
- Status last verified
- Feb 2018
- First submitted
- 21 Nov 2013
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Group A Streptococcus (GAS) Infection in Children: Bacterial Virulence Factors and Detection of Host Immunological and/or Genetic Factors of Predisposition to Infections
- ClinicalTrials.gov ID
- NCT02010294
- Acronym / sponsor ID
- StreptoPedia / P120136
- Conditions
- Invasive GAS Infection
- Keywords
- Invasive GAS infection, emm genotypes, Bacterial virulence factors, Mendelian susceptibility to infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 10 Feb 2014 (actual)
- Primary completion
- 10 Feb 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 12 Dec 2013 (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.
The main objective of the study is to characterize the virulence factors of SGA and identify immunological and / or genetic factors predisposing to infections in children hospitalized with invasive GAS infection.
Detailed description
The group A streptococcus (GAS) or Streptococcus pyogenes is a strictly human pathogen , which can cause a wide variety of infections. These range from a simple asymptomatic carriage up to 20 % of children , or minor illnesses such as sore throat or impetigo, to severe conditions such as necrotizing fasciitis and toxic shock syndrome .
The pathophysiological mechanisms of invasive GAS infections are poorly understood. These mechanisms could involve not only virulence factors of the bacterium ( M protein determines the emm genotype , but also super- antigenic exotoxins SpeA , Spe C, Ssa, Sme z or other virulence genes , SilC , ... Sic ), but also in some cases, factors associated with host immunity in particular in the absence of risk factors for invasive skin infection such as cutaneous effraction ( wound , burn , chicken pox ) , corticosteroids or other immunosuppressive therapy and recent surgery .
The investigators assume that in some invasive GAS infections, especially in children without risk factors, Mendelian susceptibility to infection may be involved . This hypothesis could be tested by studying the molecular characteristics of strains isolated SGA and innate and adaptive immunity in children hospitalised for invasive GAS infection with or without identified risk factors for infection.
This study could not only lead to a better understanding of the pathophysiological mechanisms of invasive GAS infections but also to detect in children who underwent invasive GAS genetic susceptibility to infections requiring specific care . Finally, it could also identify specific strains of SGA or molecular profiles, whose detection in practice, lead to a suspicion of hereditary immune deficiency.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children hospitalized for invasive GAS infection | – | Genetic: DNA samples, GAS strainsChildren hospitalized for invasive GAS infection |
| Children with non-invasive infection | – | Genetic: DNA samples, GAS strainsChildren with non-invasive infection such as pharyngitis, tonsillitis, proctitis or skin infection diagnosed by a positive test for rapid diagnosis of GAS performed at the site of infection with a positive GAS culture |
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children hospitalized for invasive or non invasive GAS infection
Key inclusion criteria (11 listed)
- Age ≥ 1 month to <15 years at the time of inclusion
- Group 1 : Children hospitalized for invasive GAS infection
- Proved infection : Bacteriological isolation of S. pyogenes from a liquid or a normally sterile site, except from a blister of a simple erysipelas, without necrosis . This is sometimes associated with a shock with multiorgan failure (streptococcal toxic shock syndrome ( STSS )) b ) Probable infection :
- . Bacteriological isolation of S. pyogenes from a normally non-sterile site ( eg skin, upper respiratory tract ) associated with extensive soft tissue necrosis
- . Bacteriological isolation of S. pyogenes a site or a biological sample usually non-sterile ( eg skin , upper respiratory tract ) associated with a evocative shock syndrome STSS and no other cause found .
Key exclusion criteria (2 listed)
- Group 1: Children with a known immune deficiency unrelated to the risk factors described above.
- Group 2: Children with a known immune deficiency.
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 |
|---|---|---|
| DNA samples, GAS strainsDNA samples,GAS strains | Genetic | Children hospitalized for invasive GAS infection, Children with non-invasive infection |
Primary outcome
virulence factors of GAS
Time frame: up to 3 years
characterize the virulence factors of GAS
3 secondary outcomes
Assess the frequency and type of hereditary immune deficiency or Mendelian susceptibility to infections associated with invasive GAS infections in children without risk factors
Time frame: up to 3 years
describe and compare the GAS emm genotypes and virulence factors with the profiles of strains isolated with invasive GAS infection with known risk factors and with the profile of strains isolated with a non-invasive GAS infections
Time frame: up to 3 years
compare GAS emm genotypes and profiles of virulence strains responsible for invasive SGA infections with strains causing noninvasive infections
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
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.
Albert FAYE, MD, PhD principal investigator
APHP
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 Invasive GAS 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 11 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: finished, as of the sponsor's last update on 18 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
virulence factors of GAS (time frame: up to 3 years). 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 18 Nov 2019.