Infectious DiseaseOGUSTANCT03893279
Perception of Smell and Taste During Antibiotic Treatment
An observational study of Infectious Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Disease
- What is being tested?
- Smell and Taste and questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2019to 28 May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Major patient
- Patient with bacterial infectious disease requiring antibiotic treatment.
- Having been informed about the study and not having opposed to participate
Who cannot join
- Patient under legal protection
- Patient refusing to participate
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Infectious and Tropical Diseases of the Croix Rousse Hospital of the Civil Hospitals of Lyon
Lyon, 69004
About this study
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.
- Conditions
- Infectious Disease
- Being tested
- Smell and Taste and questionnaire
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smell and Taste and questionnaireBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Time of antibiotic treatment (maximum 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start4 Oct 2019
- Primary completion28 May 2020
- Study completion28 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893279
- Sponsor's protocol ID
- 69HCL19_0117
- Acronym
- OGUSTA
- Status last verified
- Oct 2023
- First submitted
- 26 Mar 2019
- Last updated
- 10 Oct 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 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Smell and Taste During Antibiotic Treatment
- ClinicalTrials.gov ID
- NCT03893279
- Acronym / sponsor ID
- OGUSTA / 69HCL19_0117
- Conditions
- Infectious Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 28 Mar 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Major patient
- Patient with bacterial infectious disease requiring antibiotic treatment.
- Having been informed about the study and not having opposed to participate
Key exclusion criteria (2 listed)
- Patient under legal protection
- Patient refusing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smell and Taste and questionnaireThe 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. | Behavioural | – |
Primary outcome
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.
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 10 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infectious Disease, run by Hospices Civils de Lyon at 1 site in France.
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 3 inclusion and 2 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 10 Oct 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 France. 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?
Questionnaire on Perception of taste (time frame: Time of antibiotic treatment (maximum 6 months)). The study lists 2 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 10 Oct 2023.