Non-Prescription Drug MisuseNCT06521892
Interventions on Non-prescription Dispensing of Antibiotics in Community Pharmacies
A study testing social surveillance and health education interventions in people with Non-Prescription Drug Misuse and Acute Respiratory Tract Infection, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
This study was a randomized controlled trial conducted in community pharmacies. Empirical data were collected primarily using standardized patient methods. In Hubei Province, 400 community pharmacies were randomly selected and assigned to the intervention group and the control group according to the ratio of 1:1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Prescription Drug Misuse, Acute Respiratory Tract Infection
- What is being tested?
- social surveillance and health education interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2024to 25 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The qualification of retail pharmacies to sell antimicrobial drugs complies with relevant regulations and requirements, ensuring that the study participants operate legally within the regulatory framework.
- Pharmacies located in Hubei Province.
Who cannot join
- The retail pharmacy plans to undergo major changes during the study period, such as relocation, renovation, shutdown, or closure;
- Retail pharmacies that refused to respond to the call for training from the Hubei Provincial Drug Administration;
- Participants had poor compliance and do not participate in the intervention as required by the trial on multiple occasions;
- Subjects withdrew from the study on their own or were lost to follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Social Surveillance and Health Education Interventions Non-prescription Dispensing of Antibiotics in Community Pharmacies: a Randomized Controlled Trial
This study was a randomized controlled trial conducted in community pharmacies. Empirical data were collected primarily using standardized patient methods. In Hubei Province, 400 community pharmacies were randomly selected and assigned to the intervention group and the control group according to the ratio of 1:1. A one-month intervention was conducted in community pharmacies in the intervention group, which included both social surveillance and health education. First, on-site training was provided to community pharmacy staff. Respiratory physicians and pediatricians were invited to give health education lectures on disease diagnosis and treatment, medication use, etc. Second, signs were posted or hung in the community pharmacies of the intervention group, saying that "antibiotics need to be purchased with a prescription, and you are welcome to call the 12315 hotline to report if you find any sales without a prescription", in order to open up the channels of social supervision and to form a social surveillance intervention. The control group only received the regular drug supervision and management measures in Hubei Province. The primary outcome is to observe the proportion of community pharmacies selling antibiotics without a prescription.
- Being tested
- social surveillance and health education interventions
- Keywords
- antibiotic, community pharmacy, non-prescription, randomized controlled trial
- Medical subject headings
- Drug Misuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
social surveillance and health education interventionsBehavioural
Social surveillance: In the intervention group retail pharmacies posted or hung signs "antibiotics need to be purchased by prescription, if found without prescription sales, welcome to call 12315 hotline to report", to form social supervision intervention.
Health education: On-site training for retail pharmacy staff, inviting respiratory physicians and pediatricians to give health education lectures on disease diagnosis, treatment and medication.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Participants in intervention group will receive social supervision and health education interventions. Receives: Behavioral: social surveillance and health education interventions |
| control group | No intervention | Participants in control group will receive routine drug supervision and management measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of antibiotics dispensing without a prescription
Proportion of antibiotics dispensing without a prescription measured by standardized patients
Measured: baseline, First month after intervention, 3, 6, and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start25 Aug 2024
- Primary completion25 Aug 2025 (estimated)
- Study completion25 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Prescription Drug MisuseStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In parallel arm design, subjects are randomized to one or more study arms and each study arm will be allocated a different intervention. After randomization each subject stays in their assigned treatment arm for the duration of the study. Subjects receive the same treatment throughout the trial. The results are then compared
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoxv Yin, PhD, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521892
- Sponsor's protocol ID
- HuazhongU20240720
- Status last verified
- Oct 2024
- First submitted
- 20 Jul 2024
- Last updated
- 8 Oct 2024
- Results posted
- 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Social Surveillance and Health Education Interventions Non-prescription Dispensing of Antibiotics in Community Pharmacies: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06521892
- Acronym / sponsor ID
- HuazhongU20240720
- Keywords
- antibiotic, community pharmacy, non-prescription, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 25 Aug 2025 (estimated)
- First posted
- 26 Jul 2024 (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.
This study was a randomized controlled trial conducted in community pharmacies. Empirical data were collected primarily using standardized patient methods. In Hubei Province, 400 community pharmacies were randomly selected and assigned to the intervention group and the control group according to the ratio of 1:1. A one-month intervention was conducted in community pharmacies in the intervention group, which included both social surveillance and health education. First, on-site training was provided to community pharmacy staff. Respiratory physicians and pediatricians were invited to give health education lectures on disease diagnosis and treatment, medication use, etc. Second, signs were posted or hung in the community pharmacies of the intervention group, saying that "antibiotics need to be purchased with a prescription, and you are welcome to call the 12315 hotline to report if you find any sales without a prescription", in order to open up the channels of social supervision and to form a social surveillance intervention. The control group only received the regular drug supervision and management measures in Hubei Province. The primary outcome is to observe the proportion of community pharmacies selling antibiotics without a prescription.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- In parallel arm design, subjects are randomized to one or more study arms and each study arm will be allocated a different intervention. After randomization each subject stays in their assigned treatment arm for the duration of the study. Subjects receive the same treatment throughout the trial. The results are then compared
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: social surveillance and health education interventionsParticipants in intervention group will receive social supervision and health education interventions. |
| control group | No intervention | –Participants in control group will receive routine drug supervision and management measures. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The qualification of retail pharmacies to sell antimicrobial drugs complies with relevant regulations and requirements, ensuring that the study participants operate legally within the regulatory framework.
- Pharmacies located in Hubei Province.
Key exclusion criteria (4 listed)
- The retail pharmacy plans to undergo major changes during the study period, such as relocation, renovation, shutdown, or closure;
- Retail pharmacies that refused to respond to the call for training from the Hubei Provincial Drug Administration;
- Participants had poor compliance and do not participate in the intervention as required by the trial on multiple occasions;
- Subjects withdrew from the study on their own or were lost to follow-up.
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 |
|---|---|---|
| social surveillance and health education interventionsSocial surveillance: In the intervention group retail pharmacies posted or hung signs "antibiotics need to be purchased by prescription, if found without prescription sales, welcome to call 12315 hotline to report", to form social supervision intervention. Health education: On-site training for retail pharmacy staff, inviting respiratory physicians and pediatricians to give health education lectures on disease diagnosis, treatment and medication. | Behavioural | intervention group |
Primary outcome
Proportion of antibiotics dispensing without a prescription
Time frame: baseline, First month after intervention, 3, 6, and 12 months after intervention
Proportion of antibiotics dispensing without a prescription measured by standardized patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- 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. 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 social surveillance and health education interventions in people with Non-Prescription Drug Misuse and Acute Respiratory Tract Infection, run by Huazhong University of Science and Technology at 1 site in China.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Oct 2024. 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 China. 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?
Results are not available in the source record.
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?
Proportion of antibiotics dispensing without a prescription (time frame: baseline, First month after intervention, 3, 6, and 12 months after intervention). 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 8 Oct 2024.