Acute Upper Respiratory Tract InfectionsNCT02732847
Trial of Post-Dated Delayed Antibiotic Prescriptions
A study testing A delayed prescription dated 2 days after clinical office visit and Usual Dated in people with Acute Upper Respiratory Tract Infections, run by Memorial University of Newfoundland at 1 site in Canada.
Trial summary
Delayed prescriptions have been shown to lower antibiotic use for upper respiratory tract infections (which are mostly viral). This trial will test the hypothesis that if the clinician post-dates the delayed prescription by 2 days, rather than dating it on the day the patient is seen, there will be a further drop in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Upper Respiratory Tract Infections
- What is being tested?
- A delayed prescription dated 2 days after clinical office visit and Usual Dated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2007to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Adults with an untreated upper respiratory tract infection
- Adults presenting for the first time to a family physician or a nurse practitioner
Who cannot join
- Less that 18 years
- Having a clear indication for antibiotic therapy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Memorial University
St. John's, Newfoundland and Labrador, A0G 2L0
About this study
Official title: Post-Dated Versus Voluntary Delayed Antibiotic Prescriptions for Acute Respiratory Infections in Primary Care: A Randomized Trial
Delayed prescriptions have been shown to lower antibiotic use for upper respiratory tract infections (which are mostly viral).
This trial will test the hypothesis that if the clinician post-dates the delayed prescription by 2 days, rather than dating it on the day the patient is seen, there will be a further drop in the rate of antibiotic use.
Read the detailed description
6 family doctors and 2 nurse practitioners in a small rural town will issue delayed antibiotic prescriptions to adult patients with new acute respiratory tract infections. The delayed prescriptions will be randomly dated for either the day of the office visit, or 2 days later. The 2 local pharmacies will note whether the prescription is cashed, and when.
It is hypothesised that post-dating the prescription will result in a reduced cashing rate.
Each arm of the study (Usual v Post-Dated) will contain 75 subjects. This sample will have the power to detect a 25% change in prescription use.
- Conditions
- Acute Upper Respiratory Tract Infections
- Being tested
- A delayed prescription dated 2 days after clinical office visit, Usual Dated
- Keywords
- Respiratory infections, Primary care, Antibiotics, Delayed prescriptions
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A delayed prescription dated 2 days after clinical office visitOther
Usual DatedDrug
| Study group | Role | What they receive |
|---|---|---|
| Post-Dated Prescription | Other | a delayed prescription dated 2 days after clinical office visit Receives: Other: A delayed prescription dated 2 days after clinical office visit |
| Usual | Other | usual date Receives: Drug: Usual Dated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Filled a Prescription in 20 Days
Prescriptions
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startOct 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Upper Respiratory Tract InfectionsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732847
- Sponsor's protocol ID
- worrall1
- Status last verified
- Jun 2006
- First submitted
- 27 May 2010
- Last updated
- 5 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Dated Versus Voluntary Delayed Antibiotic Prescriptions for Acute Respiratory Infections in Primary Care: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02732847
- Acronym / sponsor ID
- worrall1
- Conditions
- Acute Upper Respiratory Tract Infections
- Keywords
- Respiratory infections, Primary care, Antibiotics, Delayed prescriptions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Posted 5 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Delayed prescriptions have been shown to lower antibiotic use for upper respiratory tract infections (which are mostly viral).
This trial will test the hypothesis that if the clinician post-dates the delayed prescription by 2 days, rather than dating it on the day the patient is seen, there will be a further drop in the rate of antibiotic use.
Detailed description
6 family doctors and 2 nurse practitioners in a small rural town will issue delayed antibiotic prescriptions to adult patients with new acute respiratory tract infections. The delayed prescriptions will be randomly dated for either the day of the office visit, or 2 days later. The 2 local pharmacies will note whether the prescription is cashed, and when.
It is hypothesised that post-dating the prescription will result in a reduced cashing rate.
Each arm of the study (Usual v Post-Dated) will contain 75 subjects. This sample will have the power to detect a 25% change in prescription use.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-Dated Prescription | Other | Other: A delayed prescription dated 2 days after clinical office visita delayed prescription dated 2 days after clinical office visit |
| Usual | Other | Drug: Usual Datedusual date |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years or older
- Adults with an untreated upper respiratory tract infection
- Adults presenting for the first time to a family physician or a nurse practitioner
Key exclusion criteria (2 listed)
- Less that 18 years
- Having a clear indication for antibiotic therapy
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 |
|---|---|---|
| A delayed prescription dated 2 days after clinical office visit | Other | Post-Dated Prescription |
| Usual Dated | Drug | Usual |
Primary outcome
Number of Participants That Filled a Prescription in 20 Days
Time frame: 20 days
Prescriptions
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A delayed prescription dated 2 days after clinical office visit and Usual Dated in people with Acute Upper Respiratory Tract Infections, run by Memorial University of Newfoundland at 1 site in Canada.
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: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Yes. Results are posted in the registry (first posted 5 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Filled a Prescription in 20 Days (time frame: 20 days). 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 5 May 2021.