None listed
Conditions
Brief summary
A fifth of Australian hospital patients self-report an allergy to antibiotics (“antibiotic allergy label”, AAL) which interferes with their optimal clinical care. There is strong evidence that unverified antibiotic allergy labelling is a substantial and growing public health problem resulting in: • Significant adverse patient outcomes • Increased health economic burden • Suboptimal choice of antibiotic, leading to the overuse of broad spectrum antibiotics and the emergence of microbial antibiotic resistance. International studies suggest that the majority (>90%) of subjects with AAL can safely use antibiotics without restrictions following a clinical assessment (“de-labelling”). Thus, unverified AAL is mostly inaccurate and its associated negative consequences are potentially avoidable. There is currently no effective clinical strategy developed that addresses the high national incidence of AAL in Australia. This study aims to develop a new model of care for paediatric patients with current AAL and to improve management of antibiotic therapy in our hospitals and community. A large randomised prospective study design allows for the analysis of key clinical outcomes for all study participants, with regards to details about GP and hospital visits, infection history, subsequent antibiotics usage and mortality, and compares patients which have been actively de-labelled against those receiving current standard care. This project will also calculate the true health economic cost impact of de-labelling patients at a population level, compared to standard clinical care. We hypothesise that a systematic approach to antibiotic allergy de-labelling patients with AAL will lead to a national improvement in clinical care characterised by both better long-term health outcomes and cost savings to the health budget.
Interventions
Paediatric study subjects will be randomised to receive outpatient de-labelling/verification assessment after referral to the study team (Group 1P) or usual care, which does not include antibiotic allergy label assessment (Group 2P).
In detail, the patients in Group 1P will participate in the assessment arm of the study with the objective of the unequivocal clarification of antibiotic allergy status. Clinical history taking will be completed allowing a detailed de-labelling plan to be formulated
Paediatric study subjects will be randomised to receive outpatient de-labelling/verification assessment after referral to the study team (Group 1P) or usual care, which does not include antibiotic allergy label assessment (Group 2P). In detail, the patients in Group 1P will participate in the assessment arm of the study with the objective of the unequivocal clarification of antibiotic allergy status. Clinical history taking will be completed allowing a detailed de-labelling plan to be formulated (type of assessment, type of antibiotic and route e.g. oral or intravenous). All participants will be challenged to the culprit antibiotic to which they report an antibiotic allergy to. Oral provocation challenge (where applicable) for paediatric study subjects, will be performed as a 2-stage oral provocation challenge (1/10 dose followed by 90% of the recommended dose calculated based on weight and age) or a 3-stage intravenous provocation challenge (1/100 dose followed by 1/10, followed by the remainder of the daily single dose calculated based on weight and age). An intravenous provocation challenge will only be performed in those subjects where the culprit antibiotic is known to be an intravenous antibiotic; based on our preliminary data the rate of intravenous antibiotic allergy is approximately 2% for children and 30% for adults. Doses will be given 30 minutes apart with a 1-hour observation of the patient to follow. On the testing challenge day, an experienced Immunology consultant will be present at each site in addition to the emergency response team within the hospital. In cases of unspecified ‘penicillin’ or ‘beta-lactam’ allergy patients, they will be challenged against amoxicillin (a commonly used penicillin-antibiotic in the community). Paediatric challenges will be performed in the hospital outpatient/day-stay setting. Management of reactions (including anaphylaxis) will be available at all challenge areas. If the patient does not react they will be given a five day course of the culprit/testing antibiotic to take home, together with an information sheet detailing signs of delayed reaction, how to manage them and who to contact if such a reaction occurs. All participants will receive multiple follow up calls while on the 5 day course of antibiotics to ensure compliance with taking the medication and in case of any reactions.
Sponsors
Perth Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to 16 Years
Healthy volunteers
No
Inclusion criteria
Children and young adults, male or female, aged 6 months to 16 years of age (inclusive) who have a self-reported antibiotic allergy who are willing and available for the 2 year follow up in Western Australia.
Exclusion criteria
Females who are pregnant (Pregnancy tests will be offered to sexually active females and can be performed on the day of challenge) >Families with the inability to give informed consent based on language barriers >Severe cutaneous adverse reactions >Type II-IV allergies (Serum sickness, Stevens-Johnson Syndrome (SJS), Toxic epidermal necrolysis (TEN), Acute interstitial nephritis (AIN), Drug rash eosinophilia syndrome (DRESS), Acute generalised Exanthematous Pustulosis (AGEP), Haemolytic anaemia)
Outcome results
None listed