Taste of Medicines in Children

Medication Adherence Clinical Trial

Official title:

Taste of Medicines in Children: Genetic Variation and Medication Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04220918
• Other study ID #: 19-016182
• Secondary ID: R01DC011287
• Status: Completed
• Start date: February 14, 2020
• Est. completion date: February 1, 2023

Study information

• Verified date: March 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: February 1, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Medication Adherence
• Medication Reaction

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Genome-wide association	salivary DNA	3 years

External Links

•   NIH Research Portfolio Online Reporting Tools