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.
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.
Study Type
OBSERVATIONAL
Enrollment
136
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Immediately after dosing for a total of 10 minutes
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
Time frame: 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
Time frame: 5-14 day treatment regimen given two-three times a day
Clinical outcomes
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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
Time frame: within 1 week after completion of therapy
Genome-wide association
salivary DNA
Time frame: 3 years