Medication AdherenceNCT04220918
Taste of Medicines in Children
An observational study of Medication Adherence and Medication Reaction, run by Children's Hospital of Philadelphia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Medication Adherence, Medication Reaction
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2020to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients who are prescribed clindamycin liquid at the Children's Hospital of Philadelphia (CHOP).
Who may be able to join
- 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
Who cannot join
- Unwilling or unable to produce saliva sample
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Taste of Medicines in Children: Genetic Variation and Medication Adherence
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.
Read the 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.
- Conditions
- Medication Adherence, Medication Reaction
- Keywords
- pediatrics, personalized medicine, GWAS, Taste, Side effects, clindamycin
- Medical subject headings
- Medication Adherence, Drug-Related Side Effects and Adverse Reactions
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Immediately after dosing for a total of 10 minutes
Secondary outcomes (4)
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
Measured: 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
Measured: 5-14 day treatment regimen given two-three times a day
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
Measured: within 1 week after completion of therapy
Genome-wide association
salivary DNA
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start14 Feb 2020
- Primary completion30 Sep 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Monell Chemical Senses Center
- Responsible party
- Sponsor
- Investigators
- Elizabeth D Lowenthal, MD, MSCE, Principal investigator, Children's Hospital of PhiladelphiaJulie A Mennella, PhD, Principal investigator, Monell Chemical Senses Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220918
- Sponsor's protocol ID
- 19-016182
- Other IDs
- R01DC011287
- Status last verified
- Mar 2023
- First submitted
- 3 Jan 2020
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taste of Medicines in Children: Genetic Variation and Medication Adherence
- ClinicalTrials.gov ID
- NCT04220918
- Acronym / sponsor ID
- 19-016182
- Conditions
- Medication Adherence, Medication Reaction
- Keywords
- pediatrics, personalized medicine, GWAS, Taste, Side effects, clindamycin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Monell Chemical Senses Center
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients who are prescribed clindamycin liquid at the Children's Hospital of Philadelphia (CHOP).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Unwilling or unable to produce saliva sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
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)
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
4 secondary outcomes
Medication tolerance and side effects with clindamycin use
Time frame: 5-14 day treatment regimen given two-three times a day
Treatment adherence
Time frame: 5-14 day treatment regimen given two-three times a day
Clinical outcomes
Time frame: within 1 week after completion of therapy
Genome-wide association
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth D Lowenthal, MD, MSCE principal investigator
Children's Hospital of Philadelphia
Julie A Mennella, PhD principal investigator
Monell Chemical Senses Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Adherence and Medication Reaction, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palatability of clindamycin liquid (time frame: Immediately after dosing). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.