Clinical trial NCT04220918: Taste of Medicines in Children
Official title: Taste of Medicines in Children: Genetic Variation and Medication Adherence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medication Adherence
Medication Reaction
Keywords: pediatrics
personalized medicine
GWAS
Taste
Side effects
clindamycin
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Monell Chemical Senses Center
First posted: 2020-01-07
Enrollment: 136
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients who are prescribed clindamycin liquid at the Children's Hospital of Philadelphia (CHOP).

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.

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

Primary outcomes:
measure: Palatability of clindamycin liquid
timeFrame: Immediately after dosing
measure: Palatability of clindamycin liquid
timeFrame: 5 minutes after dosing
measure: Palatability of clindamycin liquid
timeFrame: 10 minutes after dosing
measure: Taste reactivity of clindamycin liquid
timeFrame: Immediately after dosing for a total of 10 minutes
Secondary outcomes:
measure: Medication tolerance and side effects with clindamycin use
timeFrame: 5-14 day treatment regimen given two-three times a day
measure: Treatment adherence
timeFrame: 5-14 day treatment regimen given two-three times a day
measure: Clinical outcomes
timeFrame: within 1 week after completion of therapy
measure: Genome-wide association
timeFrame: 3 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Elizabeth D Lowenthal, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: Monell Chemical Senses Center
name: Julie A Mennella, PhD
role: PRINCIPAL_INVESTIGATOR
References: