Genetic Susceptibility to Severe Streptococcal Infections
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01911572|
Recruitment Status : Recruiting
First Posted : July 30, 2013
Last Update Posted : December 5, 2017
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.
|Condition or disease|
|Invasive Streptococcal Infection Invasive Group A Streptococcal Disease Invasive Group B Streptococcal Disease Necrotising Fasciitis|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Genetic Susceptibility to Invasive Streptococcal Disease|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2017|
Individuals who have previously experienced an episode of invasive streptococcal infection or necrotising fasciitis.
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.
- 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) [ Time Frame: The outcome is measured once by genetic testing using a sample collected on enrolment ('baseline'). There is no follow-up period. ]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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911572
|Contact: Tom Parks, BA MB BChir MRCP DTM&Hemail@example.com|
|University of Oxford Wellcome Trust Centre for Human Genetics||Recruiting|
|Oxford, Oxon, United Kingdom, OX3 7BN|
|Contact: Tom Parks, BA MB BChir MRCP DTM&H +447795082724 firstname.lastname@example.org|
|Principal Investigator: Tom Parks, BA MB BChir MRCP|
|Principal Investigator:||Tom Parks, BA MB BChir MRCP DTM&H||University of Oxford|