Taste of Medicines in Children

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Recruiting

CT.gov ID

NCT04220918

Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH), Monell Chemical Senses Center (Other)

240

Enrollment

Location

31.5

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Medication Adherence Medication Reaction

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

240 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Taste of Medicines in Children: Genetic Variation and Medication Adherence

Actual Study Start Date :

Feb 14, 2020

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Outcome Measures

Primary Outcome Measures

Palatability of clindamycin liquid [Immediately 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)
Palatability of clindamycin liquid [5 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)
Palatability of clindamycin liquid [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 [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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

Children's Hospital of Philadelphia
National Institute on Deafness and Other Communication Disorders (NIDCD)
Monell Chemical Senses Center

Investigators

Principal Investigator: Elizabeth D Lowenthal, MD, MSCE, Children's Hospital of Philadelphia
Principal Investigator: Julie A Mennella, PhD, Monell Chemical Senses Center