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Completed

NCT Number: NCT04220918

Taste of Medicines in Children

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.

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Key information

Conditions

Medication Adherence Behavior Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Health Behavior Medication Reaction Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Palatability of clindamycin liquid

    Time frame: 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)

  2. Palatability of clindamycin liquid

    Time frame: 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)

  3. Palatability of clindamycin liquid

    Time frame: 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)

  4. Taste reactivity of clindamycin liquid

    Time frame: 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 outcomes

  1. Medication tolerance and side effects with clindamycin use

    Time frame: 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

  2. Treatment adherence

    Time frame: 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

  3. Clinical outcomes

    Time frame: 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

  4. Genome-wide association

    Time frame: 3 years

    salivary DNA

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

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

Registry information

Official study title

Taste of Medicines in Children: Genetic Variation and Medication Adherence

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jan 7, 2020
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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