Status unknownNCT01911572Updated May 18, 2018

Genetic Susceptibility to Severe Streptococcal Infections

An observational study in Invasive Streptococcal Infection, Invasive Group A Streptococcal Disease and Invasive Group B Streptococcal Disease, sponsored by University of Oxford. Status unknown at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2018-05-18.

Sponsored by University of Oxford · Observational

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Active, not recruiting — may be out of date.

Study type: Observational
Model: Family-based
Time perspective: Other
Enrollment: 200
Sex: All

Study summary

Invasive bacterial infection is a dangerous but relatively uncommon disease where bacteria spread deep into the body causing diseases like blood poisoning ('bacteraemia'), pneumonia, meningitis and others. The various bacteria of the streptococcus family are an important cause, often leading patients to require intensive care despite which, for some strains, one in five patients die. One notable form is called necrotising fasciitis, a condition where bacteria rapidly spreads through and destroys the layers of tissue just under the skin.

As individuals vary greatly in their risk of developing such serious infections, investigating how the genome, the inherited blueprint of our bodies, of these patients differs from that of healthy volunteers can help to explain why the disease develops in some and not others. For some streptococcal bacteria such as Streptococcus pneumoniae this approach is already proving successful; for others such as the "Group A" strain (Streptococcus pyogenes) it has yet to be explored but carries excellent potential.

The investigators have secured the support of the Lee Spark Necrotising Fasciitis Foundation to recruit from their membership survivors of streptococcal infections and some of their family members. The investigators will also ask infection specialists from NHS hospitals to invite patients they have looked after. The investigators also have a small existing collection. Taking part would involve registering information on a website, discussing the study on the telephone and then providing us with a sample of saliva from which the investigators can isolate DNA. The investigators would prepare the sample for analysis of the genome and compare the patients with both their family and an existing reference collection from healthy volunteers using technology that reads the DNA code.

Our study will be a first key step in renewing efforts to understand the determinants of invasive streptococcal infection, which is important for developing better treatments and vaccines.

Conditions studied

Invasive Streptococcal Infection
Invasive Group A Streptococcal Disease
Invasive Group B Streptococcal Disease
Necrotising Fasciitis

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Keywords

Streptococcus species
Streptococcus pyogenes
Streptococcus agalactiae
Necrotising fasciitis
Sepsis

In context

Fasciitis, Necrotizing

28 studies on the registry are indexed under Fasciitis, Necrotizing; 8 are open to participants now.

This study's planned enrollment of 200 is above the median of 152 across 16 observational studies indexed under Fasciitis, Necrotizing.

Browse Fasciitis, Necrotizing studies →

Lead sponsor

University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

Participants will be identified through an invitation sent to the Lee Spark Necrotising Fasciitis Foundation and by infection specialists at NHS hospitals who will invite patients whose care they have been directly involved in. In addition, a small collection of existing samples held at Imperial College London will be used.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Participants for the genetics study are divided into cases/survivors and family members (relatives and parents).

To participate as a survivor, the individual must meet criteria 1A. Their illness can have occurred anytime from birth up until enrolment, providing it happened after 1st January 1980. Family members can only take part if invited to do so by the survivor from their family at the request of the research team.

In families in which two or more survivors are identified, all the remaining first- and second-degree relatives of the survivors will be eligible to participate. The recruitment team subdivide those relatives on enrolment into healthy (Criteria 2) or intermediate (Criteria 3) phenotype.

In families in which there is only a single survivor, the recruitment team will assess whether the survivor meets criteria 1B. If so the parents of that survivor are eligible to participate if they have a healthy phenotype (Criteria 4).

Inclusion criteria

Inclusion Criteria:

Cases/Survivors
A. All Cases (survivors in pedigree, trio or as simplex case; existing serum samples from Imperial College London collection)
- Either of:
  - Isolation of Streptococcus species from a normally sterile site (e.g. blood, joint fluid, etc.) during an acute illness since 1st January 1980
  - Severe clinical presentation - streptococcal toxic shock, necrotising fasciitis, pneumonia, puerperal sepsis, meningitis - since 1st January 1980 plus concurrent Streptococcus species isolated from non-sterile site (e.g. abscess, wound swab, pus)
- And:
  - Admitted to an NHS hospital in England or Wales or Northern Ireland
B. Trio case (survivor in trio)
- All of:
  - Meets criteria for 1A
  - Less than 40 years of age at the time of illness
  - None of at the time of the illness: heart disease, diabetes mellitus, cancer, use, chronic lung disease, immunocompromise, intravenous drug use and alcoholism
- Plus one of:
  - More than one episode of illness meeting criteria for 1A
  - Admission to high dependency or intensive care unit
  - Requirement for surgical procedure (including drainage of abscess or collection)
- And:
  - Both parents alive at time of recruitment
Unaffected phenotype family member in multi-case pedigree
- All of:
  - Biological first or second degree relative of a survivor meeting criteria 1A in a family in which two or more members meet those criteria
  - None of: severe streptococcal illness requiring hospital illness, recurrent tonsillitis or recurrent impetigo (recurrent is defined as more than one episode in two consecutive years)
Intermediate phenotype family member in multi-case pedigree
- All of:
  - Biological first or second degree relative of a survivor meeting criteria 1A in a family in which two or more members meet those criteria
  - History of severe bacterial illness requiring hospital admission, recurrent tonsillitis or recurrent impetigo (recurrent is defined as more than one episode in two consecutive years)
Parent in mother-father-child trio
- All of:
  - Biological parent of case meeting criteria for 1B
  - None of: severe bacterial illness requiring hospital admission, recurrent tonsillitis or recurrent impetigo (recurrent is defined as more than one episode in two consecutive years)

Exclusion criteria

Exclusion Criteria:

Adults (age > 16 years) unable to consent for themselves.

Terms in these criteria, in plain language(1)

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Study design

Observational model: Family-based
Time perspective: Other
Enrollment: 200 participants (estimated)
Patient registry: No
Biospecimen retention: Samples with dna

Groups and cohorts

Survivors
Individuals who have previously experienced an episode of invasive streptococcal infection or necrotising fasciitis.
Family members
Parents of those survivors aged less than forty years without risk factors for streptococcal disease (forming mother-father-child trios), or first and second degree relatives of survivors from a family in which two or more individuals have been affected.

What researchers measure

Primary outcomes

Number of genetic variants at which cases of invasive streptococcal infection (as defined in inclusion criteria 1) differ from their family members (inclusion criteria 2-4)
This is an observational study comparing genetic data from cases (inclusion criteria 1) vs unaffected family members (inclusion criteria 2-4) and publically available genetic data from health volunteers in existing reference databases (e.g. UK10K - http://www.uk10k.org/). The case's illness (as defined in inclusion criteria 1) may have occurred anytime between 1st January 1980 and enrolment. The outcome is measured by genetic testing using a sample collected on enrolment. There is no follow-up period.
Time frame: The outcome is measured once by genetic testing using a sample collected on enrolment ('baseline'). There is no follow-up period.

Study locations

1 site

University of Oxford Wellcome Trust Centre for Human Genetics
Oxford, Oxon OX3 7BN, United Kingdom

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2013, a primary completion of Dec 2017 and a completion of Dec 2019. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 4, 2013
First posted: Jul 30, 2013
Start: Dec 2013
Primary completionActual: Dec 2017
CompletionEst.: Dec 2019
Last update: May 18, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01911572
Lead sponsor: University of Oxford
Collaborators: Public Health England, Imperial College London
Responsible party: Sponsor
First posted: Jul 30, 2013
Start date: Dec 2013
Primary completion: Dec 2017
Completion: Dec 2019 (estimated)
Last update: May 18, 2018

Study contacts

Tom Parks, BA MB BChir MRCP DTM&H

principal investigator · University of Oxford

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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