NCT03893279

Brief Summary

Antibiotic use may be associated with effects on the perception of smell and taste. These effects are poorly known. The mechanisms can be very diverse, and the effect can be very variable depending on the type of antibiotic used, the dose, and the duration. The aim of this study is to analyze the perception of the taste and olfactory capacities of patients, during an antibiotic treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 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

March 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

October 4, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2020

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

March 26, 2019

Last Update Submit

October 6, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Questionnaire on Perception of taste

    Collection of scores on perception of taste, during questionnaires to be completed before, during, and after taking antibiotics. Qualitative analysis.

    Time of antibiotic treatment (maximum 6 months)

  • Questionnaire on Perception of smell

    Collection of scores on perception of smell, during questionnaires to be completed before, during, and after taking antibiotics. Qualitative analysis.

    Time of antibiotic treatment (maximum 6 months)

Interventions

The questionnaire must be completed before the antibiotic is taken, if a change of antibiotic is planned (stop of a treatment or addition of another treatment) and at the end of the antibiotic treatment.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient meeting the eligibility criteria followed in the department of Infectious and Tropical Diseases of the Croix Rousse Hospital of the Civil Hospitals of Lyon

You may qualify if:

  • Major patient
  • Patient with bacterial infectious disease requiring antibiotic treatment.
  • Having been informed about the study and not having opposed to participate

You may not qualify if:

  • Patient under legal protection
  • Patient refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Infectious and Tropical Diseases of the Croix Rousse Hospital of the Civil Hospitals of Lyon

Lyon, 69004, France

Location

MeSH Terms

Conditions

Communicable Diseases

Interventions

SmellTasteSurveys and Questionnaires

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

March 26, 2019

First Posted

March 28, 2019

Study Start

October 4, 2019

Primary Completion

May 28, 2020

Study Completion

May 28, 2020

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations