Taste of Medicines in Children

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Taste of Medicines in Children: Genetic Variation and Medication Adherence

Conditions
-----------------
Medication Adherence, Medication Reaction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Unwilling or unable to produce saliva sample

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palatability of clindamycin liquid | 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) | Immediately after dosing | 
| Palatability of clindamycin liquid | 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) | 5 minutes after dosing | 
| Palatability of clindamycin liquid | 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) | 10 minutes after dosing | 
| Taste reactivity of clindamycin liquid | Digital recordings will be analyzed for child's facial and body movements by blinded and trained reviewers | Immediately after dosing for a total of 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication tolerance and side effects with clindamycin use | Medication tolerance and side effects to medication will be measured through direct observation, parent report, and medical records | 5-14 day treatment regimen given two-three times a day | 
| Treatment adherence | Adherence to treatment course will be measured by parental report aided by a medication diary | 5-14 day treatment regimen given two-three times a day | 
| Clinical outcomes | 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 | within 1 week after completion of therapy | 
| Genome-wide association | salivary DNA | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatrics, personalized medicine, GWAS, Taste, Side effects, clindamycin