Taste of Medicines in Children: Genetic Variation and Medication Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Palatability of clindamycin liquid
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children age 3 to 12
- •Child being treated in Children's Hospital of Philadelphia
- •Being prescribed clindamycin liquid
- •Parental/guardian permission (informed consent) and if appropriate, child assent
- •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
- •Parent must have primary responsibility for the patient including biologic parents and adoptive parents (if legally allowed to consent to research)
- •Parent must be English speaking and able to understand study materials
排除标准
- •Unwilling or unable to produce saliva sample
结局指标
主要结局
Palatability of clindamycin liquid
时间窗: 10 minutes after dosing
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)
Taste reactivity of clindamycin liquid
时间窗: Immediately after dosing for a total of 10 minutes
Digital recordings will be analyzed for child's facial and body movements by blinded and trained reviewers
次要结局
- Treatment adherence(5-14 day treatment regimen given two-three times a day)
- Clinical outcomes(within 1 week after completion of therapy)
- Medication tolerance and side effects with clindamycin use(5-14 day treatment regimen given two-three times a day)
- Genome-wide association(3 years)