Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
Study NCT ID:
NCT06521892
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-10-08
First Post:
2024-07-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interventions on Non-prescription Dispensing of Antibiotics in Community Pharmacies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000076064', 'term': 'Drug Misuse'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Pharmacies participating in the study did not know which group they were assigned to. Standardized patient surveyors also did not know which group of pharmacies they surveyed.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-08-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-03', 'studyFirstSubmitDate': '2024-07-20', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of antibiotics dispensing without a prescription', 'timeFrame': 'baseline, First month after intervention, 3, 6, and 12 months after intervention', 'description': 'Proportion of antibiotics dispensing without a prescription measured by standardized patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antibiotic', 'community pharmacy', 'non-prescription', 'randomized controlled trial'], 'conditions': ['Non-Prescription Drug Misuse', 'Acute Respiratory Tract Infection']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Pharmacies located in Hubei Province.\n\nExclusion Criteria:\n\n* The retail pharmacy plans to undergo major changes during the study period, such as relocation, renovation, shutdown, or closure;\n* Retail pharmacies that refused to respond to the call for training from the Hubei Provincial Drug Administration;\n* Participants had poor compliance and do not participate in the intervention as required by the trial on multiple occasions;\n* Subjects withdrew from the study on their own or were lost to follow-up.'}, 'identificationModule': {'nctId': 'NCT06521892', 'briefTitle': 'Interventions on Non-prescription Dispensing of Antibiotics in Community Pharmacies', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'The Effect of Social Surveillance and Health Education Interventions Non-prescription Dispensing of Antibiotics in Community Pharmacies: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HuazhongU20240720'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'Participants in intervention group will receive social supervision and health education interventions.', 'interventionNames': ['Behavioral: social surveillance and health education interventions']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Participants in control group will receive routine drug supervision and management measures.'}], 'interventions': [{'name': 'social surveillance and health education interventions', 'type': 'BEHAVIORAL', 'description': '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.\n\nHealth education: On-site training for retail pharmacy staff, inviting respiratory physicians and pediatricians to give health education lectures on disease diagnosis, treatment and medication.', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430071', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Hubei Provincial Drug Administration', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Head of Social Medicne and Health Management Department', 'investigatorFullName': 'Xiaoxv Yin, PhD', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}