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Trial record 45 of 594 for:    Taste Disorders AND taste

Taste of Medicines in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04220918
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : January 30, 2020
Sponsor:
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Monell Chemical Senses Center
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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 in the emergency room, 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
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 receive a diagnosis of skin and soft tissue infection (SSTI) in the emergency department (ED) and 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 5-day 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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Taste of Medicines in Children: Genetic Variation and Medication Adherence
Actual Study Start Date : January 24, 2020
Estimated Primary Completion Date : January 15, 2022
Estimated Study Completion Date : January 15, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  1. Medication tolerance and side effects with clindamycin use [ Time Frame: 5 day treatment regimen given 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 day treatment regimen given three times a day ]
    Adherence to the five day treatment course will be measured by parental report aided by a medication diary

  3. Clinical outcomes [ Time Frame: following 5 day treatment regimen ]
    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


Biospecimen Retention:   Samples With DNA
Salivary DNA


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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients who are prescribed clindamycin liquid for treatment of skin and soft tissue infection (SSTI) at the Children's Hospital of Philadelphia (CHOP) emergency department (ED).
Criteria

Inclusion Criteria:

  • Children age 3 to 10
  • Child being treated in Children's Hospital of Philadelphia Emergency Department
  • Diagnosis of a skin or soft tissue infection (SSTI)
  • Being prescribed clindamycin liquid for outpatient use
  • 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:

  • Inpatient (child)
  • Known exposure to (use of) clindamycin anytime in the child's past (assessed by review of CHOP prescribing record and parental report)
  • Unwilling or unable to produce saliva sample

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04220918


Contacts
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Contact: Elizabeth D Lowenthal, MD, MSCE 267-426-2306 lowenthale@email.chop.edu
Contact: Conor Drakeley, MS drakeleyc@email.chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Elena Tsemberis       tsemberie1@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Institute on Deafness and Other Communication Disorders (NIDCD)
Monell Chemical Senses Center
Investigators
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Principal Investigator: Elizabeth D Lowenthal, MD, MSCE Children's Hospital of Philadelphia
Principal Investigator: Julie A Mennella, PhD Monell Chemical Senses Center

Additional Information:
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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT04220918    
Other Study ID Numbers: 19-016182
R01DC011287 ( U.S. NIH Grant/Contract )
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
pediatrics
personalized medicine
GWAS
Taste
Side effects
clindamycin
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders