Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-01-02 @ 8:44 AM
Study NCT ID:
NCT03368768
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2017-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Footprint Thailand - Pilot Questionnaire Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 237}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-14', 'studyFirstSubmitDate': '2017-10-30', 'studyFirstSubmitQcDate': '2017-12-04', 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total antibiotic usage in human population', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Association between the antibiotic usage and the episodes of common cold', 'timeFrame': '1 year', 'description': 'Association between the antibiotic usage and the episodes of common cold or diarrhea in Thai adult population'}, {'measure': 'Association between the antibiotic usage and the episodes of diarrhea', 'timeFrame': '1 year', 'description': 'Association between the antibiotic usage and the episodes of common cold or diarrhea in Thai adult population'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antimicrobial-resistant bacterial infection', 'Questionaire'], 'conditions': ['Antibiotic Usage']}, 'descriptionModule': {'briefSummary': 'Antimicrobial-resistant bacterial infection is an important cause of death in Thailand and in other countries worldwide. Increasing use of antibiotics in both animals and humans is one of the main drive that increase the incidence of antimicrobial resistant bacteria in human, animals and environment.\n\nNational Action Plan for Combating Antibiotic-resistant Bacteria aimed to have general population taking antibiotics less than 20% when they have common cold or diarrheal symptoms. However, there is little accurate information about behaviors of Thai people. Most studies were conducted in hospitals, clinics or pharmacy. Therefore, it did not include behaviors of those who had symptoms but did not present at hospitals, clinics or pharmacy.\n\nIn this study, the investigators aim to use questionnaire to Thai adult population to ask for the the amount of antibiotic used and the periods they had symptoms of common cold or diarrhea over one year period of year 2017. The main aim is to estimate the total antibiotic usage per human population, and plan for the study in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study aims to have at least 100 adult people who could provide information for the total of one year. This expects that at least 20 of those 100 people would have common cold or diarrhea at least one time over one year period. This should provide more than 80% power to detect whether the proportion of having antibiotics when they have common cold or diarrhea was lower than 50% or not. The hypothesizjed proportion was 20% as stated by the national strategy against AMR in Thailand.\n\nMORU has a total number of staff for more than 200 people, and we suspect that the internal people in MORU should be enough for the study. We will also want to pilot whether the internet-based study can spread into the community well or not.', 'genderDescription': 'Living in Thailand (staying in Thailand more than 6 months per year)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe participant may enter the study if ALL of the following apply:\n\n1. Participant is willing and able to give informed consent for participation in the study.\n2. Male or female, aged 18 years or above.\n3. Living in Thailand (staying in Thailand more than 6 months per year)\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT03368768', 'acronym': 'AFT PILOT', 'briefTitle': 'Antibiotic Footprint Thailand - Pilot Questionnaire Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Antibiotic Footprint Thailand - Pilot Questionnaire Study', 'orgStudyIdInfo': {'id': 'MICRO1704'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Contact group email of Mahidol-Oxford Research Unit (MORU)', 'description': 'The investigator aims to have at least 100 adult people who could provide information for the total of one year. This expects that at least 20 of those 100 people would have common cold or diarrhea at least one time over one year period. This should provide more than 80% power to detect whether the proportion of having antibiotics when they have common cold or diarrhea was lower than 50% or not. The hypothesized proportion was 20% as stated by the national strategy against AMR in Thailand', 'interventionNames': ['Other: Obtain inform consent via questionnaire of Monkey Survey']}], 'interventions': [{'name': 'Obtain inform consent via questionnaire of Monkey Survey', 'type': 'OTHER', 'description': 'This is an internet-based questionnaire study. Therefore, anyone in Thailand can access and answer the questionnaire.', 'armGroupLabels': ['Contact group email of Mahidol-Oxford Research Unit (MORU)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Thailand', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}