Antimicrobial Stewardship Effects of Interpretive Comments for Faecal PCR Tests

NCT07701135 | Recruiting

• 1 other identifier: FPC2026
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 4

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.

Conditions

Gastroenteritis Acute; Diagnostic Communication

Keywords

Bacterial gastroenteritis; Laboratory diagnosis; Antimicrobial stewardship

Outcome Measures

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

  Within 5 days of lab report

Secondary Outcomes (3)

• Any antibacterial dispensing

  Within 5 days of lab report

• Antibacterial dispensing within 30 days

  Within 30 days of lab report

• Unplanned hospital admission

  Within 5 and 30 days of lab report.

Study Arms (4)

Interpretive laboratory comment - guideline

ACTIVE COMPARATOR

Interpretive comment with advice to follow local guidelines

Other: Interpretive comment on laboratory report

Interpretive laboratory comment - guideline + population harms

ACTIVE COMPARATOR

Interpretive comment with advice to follow local guidelines PLUS comment about population level harms of antibiotic overuse (i.e. AMR)

Other: Interpretive comment on laboratory report

Interpretive laboratory comment - guideline + individual harms

ACTIVE COMPARATOR

Interpretive comment with advice to follow local guidelines PLUS comment about individual patient harms of antibiotic overuse (e.g. side effects)

Other: Interpretive comment on laboratory report

Control

NO INTERVENTION

No comment added to lab report

Interventions

Interpretive comment on laboratory report OTHER

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

Interpretive laboratory comment - guideline; Interpretive laboratory comment - guideline + individual harms; Interpretive laboratory comment - guideline + population harms

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Research Institute of New Zealand: lead
• Awanui Labs: collaborator

Study Sites (4)

Awanui Labs Auckland

Auckland, New Zealand

RECRUITING

Awanui Labs Christchurch

Christchurch, New Zealand

RECRUITING

Awanui Labs Dunedin

Dunedin, New Zealand

RECRUITING

Awanui Labs Wellington

Wellington, 6012, New Zealand

RECRUITING

Central Study Contacts

Max Bloomfield, MBChB

CONTACT

+64272089584; maxim.bloomfield@ccdhb.org.nz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomised trial

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): September 17, 2027
• Study Completion (Estimated): September 17, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (4)