Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT04220918
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2020-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Taste of Medicines in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Salivary DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-02', 'studyFirstSubmitDate': '2020-01-03', 'studyFirstSubmitQcDate': '2020-01-06', 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Palatability of clindamycin liquid', 'timeFrame': 'Immediately after dosing', 'description': 'Taste ratings by the child using a hedonic face scale (scale = 1-5; 1=dislike a lot, 2=dislike a little, 3=neither like nor dislike, 4=like a little, 5=like a lot)'}, {'measure': 'Palatability of clindamycin liquid', 'timeFrame': '5 minutes after dosing', 'description': 'Taste ratings by the child using a hedonic face scale (scale = 1-5; 1=dislike a lot, 2=dislike a little, 3=neither like nor dislike, 4=like a little, 5=like a lot)'}, {'measure': 'Palatability of clindamycin liquid', 'timeFrame': '10 minutes after dosing', 'description': 'Taste ratings by the child using a hedonic face scale (scale = 1-5; 1=dislike a lot, 2=dislike a little, 3=neither like nor dislike, 4=like a little, 5=like a lot)'}, {'measure': 'Taste reactivity of clindamycin liquid', 'timeFrame': 'Immediately after dosing for a total of 10 minutes', 'description': "Digital recordings will be analyzed for child's facial and body movements by blinded and trained reviewers"}], 'secondaryOutcomes': [{'measure': 'Medication tolerance and side effects with clindamycin use', 'timeFrame': '5-14 day treatment regimen given two-three times a day', 'description': 'Medication tolerance and side effects to medication will be measured through direct observation, parent report, and medical records'}, {'measure': 'Treatment adherence', 'timeFrame': '5-14 day treatment regimen given two-three times a day', 'description': 'Adherence to treatment course will be measured by parental report aided by a medication diary'}, {'measure': 'Clinical outcomes', 'timeFrame': 'within 1 week after completion of therapy', 'description': 'Clinical outcome of infection (cured on clindamycin vs not cured on clindamycin) will be measured through medical record review and parental report during follow-up interview'}, {'measure': 'Genome-wide association', 'timeFrame': '3 years', 'description': 'salivary DNA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatrics', 'personalized medicine', 'GWAS', 'Taste', 'Side effects', 'clindamycin'], 'conditions': ['Medication Adherence', 'Medication Reaction']}, 'descriptionModule': {'briefSummary': 'Some but not all children will refuse to take medicine because of its taste, which can lead to substantial worsening of disease, antibiotic resistance, increased health care costs, and even death. The investigators are systematically assessing individual variation in the taste of liquid clindamycin among genotyped pediatric patients prescribed clindamycin for standard of care treatment, to determine whether (1) genetic variation underlies differences in taste ratings of the antibiotic; (2) initial taste responses, genetics, or both predict likelihood of side effects and medication non-adherence.', 'detailedDescription': "Taste plays an integral role in whether a child accepts a medicine. Some children will like the taste of a given medicine and complete the full course of treatment, whereas others will strongly reject its taste, suffer taste-modulated side effects, or both. This study will systematically measure initial palatability and reactions to the first dose of an antibiotic (clindamycin, liquid formulation) by pediatric patients who are receiving clindamycin as part of their standard of care treatment. Saliva will be collected from all patients for GWAS. Taste response, tolerance of the medication, adherence and clinical outcomes will be assessed. Subjects will be followed to determine if they complete the prescribed medication regimen (adherence) and/or experience side effects (tolerability). Because medication-specific side effects have patient-specific variability, the investigators will determine whether the child's initial taste responses, genes, or both predict subsequent side effects and medication adherence."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Pediatric patients who are prescribed clindamycin liquid at the Children's Hospital of Philadelphia (CHOP).", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children age 3 to 12\n* Child being treated in Children's Hospital of Philadelphia\n* Being prescribed clindamycin liquid\n* Parental/guardian permission (informed consent) and if appropriate, child assent\n* Parent age 18 or older, or a minor permitted by state law to consent for their own participation and for the participation of their child\n* Parent must have primary responsibility for the patient including biologic parents and adoptive parents (if legally allowed to consent to research)\n* Parent must be English speaking and able to understand study materials\n\nExclusion Criteria:\n\n* Unwilling or unable to produce saliva sample"}, 'identificationModule': {'nctId': 'NCT04220918', 'briefTitle': 'Taste of Medicines in Children', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Taste of Medicines in Children: Genetic Variation and Medication Adherence', 'orgStudyIdInfo': {'id': '19-016182'}, 'secondaryIdInfos': [{'id': 'R01DC011287', 'link': 'https://reporter.nih.gov/quickSearch/R01DC011287', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Elizabeth D Lowenthal, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}, {'name': 'Julie A Mennella, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monell Chemical Senses Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}, {'name': 'Monell Chemical Senses Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}