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Perception of Smell and Taste During Antibiotic Treatment (OGUSTA)

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ClinicalTrials.gov Identifier: NCT03893279
Recruitment Status : Not yet recruiting
First Posted : March 28, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date March 26, 2019
First Posted Date March 28, 2019
Last Update Posted Date March 29, 2019
Estimated Study Start Date April 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2019)
  • Questionnaire on Perception of taste [ Time Frame: Time of antibiotic treatment (maximum 6 months) ]
    Collection of scores on perception of taste, during questionnaires to be completed before, during, and after taking antibiotics. Qualitative analysis.
  • Questionnaire on Perception of smell [ Time Frame: Time of antibiotic treatment (maximum 6 months) ]
    Collection of scores on perception of smell, during questionnaires to be completed before, during, and after taking antibiotics. Qualitative analysis.
Original Primary Outcome Measures
 (submitted: March 26, 2019)
  • Perception of taste [ Time Frame: Time of antibiotic treatment (maximum 6 months) ]
    Collection of scores on perception of taste, during questionnaires to be completed before, during, and after taking antibiotics. Qualitative analysis.
  • Perception of smell [ Time Frame: Time of antibiotic treatment (maximum 6 months) ]
    Collection of scores on perception of smell, during questionnaires to be completed before, during, and after taking antibiotics. Qualitative analysis.
Change History Complete list of historical versions of study NCT03893279 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Perception of Smell and Taste During Antibiotic Treatment
Official Title Perception of Smell and Taste During Antibiotic Treatment
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-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
Condition Infectious Disease
Intervention Behavioral: Smell and Taste and questionnaire
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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: March 26, 2019)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient under legal protection
  • Patient refusing to participate
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Tristan FERRY, Pr 04 72 07 24 81 ext +33 tristan.ferry@chu-lyon.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03893279
Other Study ID Numbers 69HCL19_0117
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date March 2019