NCT07701135 Antimicrobial Stewardship Effects of Interpretive Comments for Faecal PCR Tests
| NCT ID | NCT07701135 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical Research Institute of New Zealand |
| Condition | Gastroenteritis Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2026-06-02 |
| Primary Completion | 2027-09-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10,000 participants in total. It began in 2026-06-02 with a primary completion date of 2027-09-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07701135 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, studying Gastroenteritis Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07701135 currently recruiting?
Yes, NCT07701135 is actively recruiting participants. Contact the research team at maxim.bloomfield@ccdhb.org.nz for enrollment information.
Where is the NCT07701135 trial being conducted?
This trial is being conducted at Auckland, New Zealand, Christchurch, New Zealand, Dunedin, New Zealand, Wellington, New Zealand.
Who is sponsoring the NCT07701135 clinical trial?
NCT07701135 is sponsored by Medical Research Institute of New Zealand. The trial plans to enroll 10,000 participants.