Improved diagnostics for Paediatric Tuberculosis (TIKA-PAEDTB)

Status: Open to recruitment 

Population: Paediatric (patients below the age of 21 years)  

Disease group: Tuberculosis (TB) 

Funder: Innovate UK 

Sponsor: St George’s University Hospitals NHS Foundation Trust 

Principle Investigator: Dr Catherine Cosgrove

Study Aims

Tuberculosis (TB) is a growing problem worldwide. The current methods for diagnosing Tuberculosis are time consuming which may delay diagnosis and treatment for many weeks. It is also difficult to obtain good samples from young patients. As they cannot be asked to cough, using an aspirator to wash-out material from the lungs or swallowed secretions from the stomach is necessary. This requires skill from highly trained personnel to perform well and is understandably traumatic. It often deters investigations except in the most extreme cases, making routine screening impractical. 

In this study we wish to take faecal (poo/stool) samples from patients to see if we can improve and speed up the diagnosis of TB. The bacterium that causes TB (Mycobacterium tuberculosis) is a very hardy organism, very capable of surviving passage through the gut and it has been shown that faeces are a good source.  

 What does participating in the study involve?  

TB will be diagnosed in the usual way, by clinical evaluation and routine analysis of appropriate samples, including standard PCR and culture. Patients will be managed in the usual way, according to standard protocols for treating TB as directed by the treating physician. This study will not interfere in any way with this process.   

Parents/Guardians of potential participants and over 16 years potential participants will be approached by the routine clinical team and asked if they would be interested to participate. If you express an interest one of the clinical research team will contact you. If you are suitable for the study and are able to give consent, we will arrange for a faecal (poo/stool) sample to be collected.  

We will also take some details about your child’s clinical care, either from the medical notes or from asking you or your child questions. These details will include sex, age and country of birth, what symptoms they have and for how long, and other medical history. We will also confirm your child’s treatment history and check any results from the standard laboratory samples that were sent.  

If your child takes part in the study, they will be given a unique study number which will be used on all documents. This unique study number will also be marked on the faecal (poo/stool) sample when it is sent to the research laboratory. Your child’s name will not be used to maintain anonymity.  

It is up to you to decide whether or not you wish to take part, and you can withdraw at any time, without giving a reason.