NCT04220918

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 14, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

2.6 years

First QC Date

January 3, 2020

Last Update Submit

March 2, 2023

Conditions

Medication AdherenceMedication Reaction

Keywords

pediatricspersonalized medicineGWASTasteSide effectsclindamycin

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

  • Medication tolerance and side effects with clindamycin use

    5-14 day treatment regimen given two-three times a day

  • Treatment adherence

    5-14 day treatment regimen given two-three times a day

  • Clinical outcomes

    within 1 week after completion of therapy

  • Genome-wide association

    3 years

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients who are prescribed clindamycin liquid at the Children's Hospital of Philadelphia (CHOP).

You may qualify if:

  • 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

You may not qualify if:

  • Unwilling or unable to produce saliva sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Salivary DNA

MeSH Terms

Conditions

Medication AdherenceDrug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorChemically-Induced Disorders

Study Officials

  • Elizabeth D Lowenthal, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

  • Julie A Mennella, PhD

    Monell Chemical Senses Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 7, 2020

Study Start

February 14, 2020

Primary Completion

September 30, 2022

Study Completion

February 1, 2023

Last Updated

March 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)