Rapid Acute Paediatric Diagnosis of Infection in Suspected Sepsis (RAPIDS)

Testing a new way to rapidly diagnose life-threatening infections in infants and children

Sepsis and life-threatening infections are one of the most common reasons for children to present to Emergency Departments and Intensive Care Units. One of the biggest challenges in treating sepsis is the time required to obtain the accurate diagnosis of the infection, and to decide if and what antibiotics are required. Gene-expression and gene-sequencing based (“genomics”) sepsis diagnosis is likely superior to traditional infection testing. But these new tests have not yet been trialled in a larger study. This is the reason why we need to do this study.

Information for parents and guardians of our patients

What is RAPIDS

RAPIDS stand for Rapid Acute Paediatric Diagnosis of Infection in Suspected Sepsis.  Testing a new way to rapidly diagnose life-threatening infections in infants and children. Our genes (“our DNA”) are responsible for certain proteins and processes in our body – one of which is the defence against infections. The way genes are activated (“expressed”) in the blood can give clues as to whether an infection is present. In addition, it may give clues to what type of infection (viral, bacterial) and how severe an infection is present.

Why are we conducting the RAPIDS Study?

We are researching a blood test, which may provide a test result within hours (i.e. whether a viral or bacterial infection is present). We are using the most modern tests looking at the children’s genes for this purpose (so called gene expression). We want to find out if we could and should use this new technology in the future to become a standard of care.  This could lead to better treatment of infections and reduce unnecessary antibiotic use.

Gene-expression and gene-sequencing based (“genomics”) sepsis diagnosis is likely superior to traditional infection testing. But these new tests have not yet been trialled in a larger study. This is the reason why we need to do this study.

Who can take part in the trial?

Patients aged >1 month to <18 years admitted to Emergency Departments or PICU with suspected hospital or community acquired infection, requiring a septic work-up including conventional blood cultures by the treating physician.

What does be part of RAPIDS involve?

When children may have suspected or known sepsis and/or septic shock, blood is sampled, and routine testing is conducted.  When routine sampling of bloods is occurring an additional small portion (5mls) of blood will be collected and stored. We will again check about 48 hours later if child is still in hospital; if a line to draw blood is still being used at that time point, then we will collect an additional small amount of blood (5mls) once more. Data from child’s medical record will also be collected.

Please note that medical decisions about child’s treatment will still be based on current means of testing.  Therefore, the genetic testing will be conducted purely for research purposes and will not confer any advantage or disadvantage to child’s treatment. Participation in this study will not change the way your child is treated. The study results will take months to years to become available.

This study will not have any direct benefits for the child enrolled.  However, it will help us gain an understanding of the effectiveness of this genetic testing, which may improve how we manage children in the future.

Consent

Where possible, we will talk to parents/guardians before starting the treatment and get the consent to include their child in the trial. However, due to the emergency nature of sepsis and septic shock, it is anticipated that in certain situations timely informed consent may not be feasible in which case consent to continue (delayed consent) will be used.  Our Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee has given this study special approval, whereby children can be included in the study before you have given consent. This is because the RAPIDS Study does not put child at risk of any harm. Informed consent will be sought from the parent/guardian as soon as possible once the child has been stabilized and the parent/guardian has had time to adjust to the emergency environment.

The Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC) has approved this study. If you have any concerns and/or complaints about the project, the way it is being conducted or your child’s rights as a research participant, and would like to speak to someone independent of the project, please contact the HREC Coordinator.
t: 3069 7002
e: CHQETHICS@health.qld.gov.au

Participating sites

  • Queensland Children’s Hospital, Brisbane, Queensland, Australia
  • Gold Coast University Hospital, Gold Coast, Queensland, Australia
  • Townsville Hospital, Townsville, Queensland, Australia
  • Thursday Island Hospital, Far North Queensland, Australia

Location

Centre for Children’s Health Research
Queensland Children’s Hospital Precinct
Paediatric Critical Care Research Group
Level 6, 62 Graham Street
South Brisbane, Qld, 4101
Australia

Central team (CCHR – Brisbane)

For study queries contact

Study Coordinators

Zoe Sever
e: z.sever@uq.edu.au
CN Natalie Sharp
e: Natalie.Sharp2@health.qld.gov.au

Principal Investigators

Dr Sai Raman
e: sainath.raman@uq.edu.au
A/Prof Luregn Schlapbach
e: l.schlapbach@uq.edu.au