Antimicrobial Stewardship Effects of Interpretive Comments for Faecal PCR Tests

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorMedical Research Institute of New Zealand

About this trial

Bacterial gastroenteritis is a common condition seen in Aotearoa New Zealand, which is typically diagnosed by PCR testing on a stool sample. Most causes of bacterial gastroenteritis (e.g. Campylobacter spp, Salmonella spp, Yersinia spp) cause a self-limiting illness and antibiotic therapy is not required. Indeed, guidelines available for community healthcare providers in Aotearoa (e.g. Community HealthPathways, recently released national antimicrobial guidelines Te Whata Kura) recommend against antibiotic therapy for the vast majority of cases.

A recent internal analysis at Awanui Laboratories of community faecal pathogen PCR testing revealed that antibiotic prescribing was very common after a positive result (ranging between 20-40% for the various individual pathogens), which suggests many community healthcare providers may not be following the recommended approach for the management of these infections. Given how common infectious gastroenteritis is in Aotearoa, and the volume of tests performed (approximately 100,000 through the Awanui network per year), this prescribing behaviour may represent a large volume of unnecessary antibiotic use in our communities, with resultant potential harmful effects at the individual patient level and population level via side effects, disruption to the faecal microbiome, and impacts on antimicrobial resistance (AMR).

In previous work we have demonstrated that interpretive comments, when added to laboratory reports, can have a significant positive effect on prescriber behaviour (https://doi.org/10.1093/jac/dkad384), but this has not been examined in relation to faecal pathogen testing.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age over six months

Stool sample submitted to Awanui Labs for faecal bacterial pathogen testing from a community health provider during the study period

Test results report the detection of: Campylobacter spp, Shigella spp/Entero-invasive Escherichia coli, Salmonella spp, Yersinia spp, or Aeromonas spp.

Disqualifiers

Samples where only Clostridioides difficile or Helicobacter pylori testing has been requested will be excluded

Samples sent for Public Health testing (e.g. testing for clearance of Salmonella spp) will be excluded.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Interpretive comment on laboratory report

    Other intervention

    Interpretive commend added to laboratory report - contents of comment will depend on associated arm

Treatment groups

10,000 Participants
are divided into 4 treatment groups
Group A: Interpretive laboratory comment - guidelineActive comparator 1 intervention
Group B: Interpretive laboratory comment - guideline + population harmsActive comparator 1 intervention
Group C: Interpretive laboratory comment - guideline + individual harmsActive comparator 1 intervention
Group D: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Specific antibacterial dispensing

Antibacterial dispensing within 5 days of laboratory report for agents that are more specific for the treatment of bacterial gastroenteritis: amoxicillin, azithromycin, ciprofloxacin, doxycycline, erythromycin, co-trimoxazole

Time frame
Within 5 days of lab report

Secondary outcomes

1

Any antibacterial dispensing

Antimicrobial dispensing within 5 days of laboratory report for any antibacterial agent

Time frame
Within 5 days of lab report
2

Antibacterial dispensing within 30 days

Antimicrobial dispensing within 30 days of laboratory report 1. For any antibacterial agent 2. Limited to these agents that are more specific for the treatment of bacterial AG: amoxicillin, azithromycin, ciprofloxacin, doxycycline, erythromycin, co-trimoxazole

Time frame
Within 30 days of lab report
3

Unplanned hospital admission

Unplanned hospital admission within 5 and 30 days of laboratory report

Time frame
Within 5 and 30 days of lab report.

Other outcomes

Sponsors and contacts

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