Gastroenteritis AcuteNCT07701135
Antimicrobial Stewardship Effects of Interpretive Comments for Faecal PCR Tests
A study testing Interpretive comment on laboratory report in people with Gastroenteritis Acute and Diagnostic Communication, run by Medical Research Institute of New Zealand at 4 sites in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Gastroenteritis Acute, Diagnostic Communication
- What is being tested?
- Interpretive comment on laboratory report
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 4 sitesNew Zealand
- Study dates
- 2 Jun 2026to 17 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand4 sites, 4 recruiting
- Recruiting
Awanui Labs Auckland
Auckland
Max Bloomfield, MBChB, 0272089584, maxim.bloomfield@ccdhb.org.nz
- Recruiting
Awanui Labs Christchurch
Christchurch
Max Bloomfield, MBChB, 0272089584, maxim.bloomfield@ccdhb.org.nz
- Recruiting
Awanui Labs Dunedin
Dunedin
Max Bloomfield, MBChB, 0272089584, maxim.bloomfield@ccdhb.org.nz
- Recruiting
Awanui Labs Wellington
Wellington, 6012
Max Bloomfield, MBChB, 0272089584, maxim.bloomfield@ccdhb.org.nz
About this study
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.
Read the detailed description
This is a cluster randomised crossover trial, where four laboratories within the Awanui Labs network in Aotearoa New Zealand will act as the clusters. Each laboratory will be assigned four intervention levels, which will be implemented in random order over the course of the 12 month study period (i.e. 3 months per intervention).
The intervention will consist of interpretive comments that are appended to laboratory reports where a stool sample has been submitted for faecal bacterial pathogen detection (predominantly tested via multiplex PCR methodology) and one of the target organisms has been detected. The target organisms are Campylobacter spp, Shigella spp/Entero-invasive Escherichia coli, Salmonella spp, Yersinia spp, and Aeromonas spp.
There will be four different intervention levels: 1. a comment that reminds requesters that most acute bacterial gastroenteritis does not require antibiotic treatment, as per local guidelines; 2. the same comment as 1 is used, plus an additional comment is added reminding requesters of the negative effects of antibiotic over use at the population level (i.e. AMR); 3. the same comment as 1 is used, plus an additional comment is added reminding requesters of the negative effects of antibiotic overuse at the individual patient level e.g. harms due to side effects; 4. is a the control group, where no comment is appended.
The four levels will be auto added by each lab, each for a three month period, in the random order allocated at the beginning of the study.
Outcome measures will relate to antibiotic use in the time period following the laboratory report, plus unplanned hospitalisation out to 30 days post report.
- Conditions
- Gastroenteritis Acute, Diagnostic Communication
- Being tested
- Interpretive comment on laboratory report
- Keywords
- Bacterial gastroenteritis, Laboratory diagnosis, Antimicrobial stewardship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpretive comment on laboratory reportOther
Interpretive commend added to laboratory report - contents of comment will depend on associated arm
| Study group | Role | What they receive |
|---|---|---|
| Interpretive laboratory comment - guideline | Active comparator | Interpretive comment with advice to follow local guidelines Receives: 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) Receives: 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) Receives: Other: Interpretive comment on laboratory report |
| Control | No intervention | No comment added to lab report |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 5 days of lab report
Secondary outcomes (3)
Any antibacterial dispensing
Antimicrobial dispensing within 5 days of laboratory report for any antibacterial agent
Measured: Within 5 days of lab report
Antibacterial dispensing within 30 days
Antimicrobial dispensing within 30 days of laboratory report
- For any antibacterial agent
- Limited to these agents that are more specific for the treatment of bacterial AG: amoxicillin, azithromycin, ciprofloxacin, doxycycline, erythromycin, co-trimoxazole
Measured: Within 30 days of lab report
Unplanned hospital admission
Unplanned hospital admission within 5 and 30 days of laboratory report
Measured: Within 5 and 30 days of lab report.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start2 Jun 2026
- Primary completion17 Sep 2027 (estimated)
- Study completion17 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroenteritis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cluster randomised trial
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Institute of New Zealand
- Sponsor type
- University, hospital or other
- Collaborators
- Awanui Labs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701135
- Sponsor's protocol ID
- FPC2026
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Stewardship Effects of Interpretive Comments for Faecal PCR Tests
- ClinicalTrials.gov ID
- NCT07701135
- Acronym / sponsor ID
- FPC2026
- Conditions
- Gastroenteritis Acute, Diagnostic Communication
- Keywords
- Bacterial gastroenteritis, Laboratory diagnosis, Antimicrobial stewardship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Medical Research Institute of New ZealandUniversity, hospital or other
- Collaborators
- Awanui Labs
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 17 Sep 2027 (estimated)
- Study completion
- 17 Sep 2027 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a cluster randomised crossover trial, where four laboratories within the Awanui Labs network in Aotearoa New Zealand will act as the clusters. Each laboratory will be assigned four intervention levels, which will be implemented in random order over the course of the 12 month study period (i.e. 3 months per intervention).
The intervention will consist of interpretive comments that are appended to laboratory reports where a stool sample has been submitted for faecal bacterial pathogen detection (predominantly tested via multiplex PCR methodology) and one of the target organisms has been detected. The target organisms are Campylobacter spp, Shigella spp/Entero-invasive Escherichia coli, Salmonella spp, Yersinia spp, and Aeromonas spp.
There will be four different intervention levels: 1. a comment that reminds requesters that most acute bacterial gastroenteritis does not require antibiotic treatment, as per local guidelines; 2. the same comment as 1 is used, plus an additional comment is added reminding requesters of the negative effects of antibiotic over use at the population level (i.e. AMR); 3. the same comment as 1 is used, plus an additional comment is added reminding requesters of the negative effects of antibiotic overuse at the individual patient level e.g. harms due to side effects; 4. is a the control group, where no comment is appended.
The four levels will be auto added by each lab, each for a three month period, in the random order allocated at the beginning of the study.
Outcome measures will relate to antibiotic use in the time period following the laboratory report, plus unplanned hospitalisation out to 30 days post report.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Cluster randomised trial
| Arm | Type | Receives |
|---|---|---|
| Interpretive laboratory comment - guideline | Active comparator | Other: Interpretive comment on laboratory reportInterpretive comment with advice to follow local guidelines |
| Interpretive laboratory comment - guideline + population harms | Active comparator | Other: Interpretive comment on laboratory reportInterpretive comment with advice to follow local guidelines PLUS comment about population level harms of antibiotic overuse (i.e. AMR) |
| Interpretive laboratory comment - guideline + individual harms | Active comparator | Other: Interpretive comment on laboratory reportInterpretive comment with advice to follow local guidelines PLUS comment about individual patient harms of antibiotic overuse (e.g. side effects) |
| Control | No intervention | –No comment added to lab report |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpretive comment on laboratory reportInterpretive commend added to laboratory report - contents of comment will depend on associated arm | Other | Interpretive laboratory comment - guideline, Interpretive laboratory comment - guideline + individual harms, Interpretive laboratory comment - guideline + population harms |
Primary outcome
Specific antibacterial dispensing
Time frame: Within 5 days of lab report
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
3 secondary outcomes
Any antibacterial dispensing
Time frame: Within 5 days of lab report
Antibacterial dispensing within 30 days
Time frame: Within 30 days of lab report
Unplanned hospital admission
Time frame: Within 5 and 30 days of lab report.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpretive comment on laboratory report in people with Gastroenteritis Acute and Diagnostic Communication, run by Medical Research Institute of New Zealand at 4 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Max Bloomfield, MBChB (+64272089584, maxim.bloomfield@ccdhb.org.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific antibacterial dispensing (time frame: Within 5 days of lab report). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.