Colonization, AsymptomaticNCT05231499
Immunity and Nasal Fungal Colonization
An observational study of Colonization, Asymptomatic, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
Fungal colonization causes opportunistic infection that may manifest when the host's immune status deteriorates. The purpose of this study was to determine the prevalence of fungal colonization in immunocompromised subjects compared to healthy controls. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colonization, Asymptomatic
- What is being tested?
- nasal irrigation
- How many people
- 58 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Aug 2018to 27 Jul 2020
- How long will I take part?
- 1 Month
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Immunocompromised subjects have rhinosinusitis or not using nasal irrigation or not using nasal irrigation
Who may be able to join
- Immunocompromised subjects included those who had known risk factors for fungal infection, including malignant diseases, diabetes, autoimmune disorders, renal or hepatic insufficiency, organ transplantation, or use of immunosuppressants
- Healthy volunteers had neither sinonasal symptoms nor nasal endoscopic inflammation.
Who cannot join
- Patients were excluded if they were under 20 years old, were receiving antifungal medication, or were pregnant.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Otolaryngology, Taichung Veterans General Hospital
Taichang, 40705
About this study
Official title: Host Immunity and Nasal Fungal Colonization
Fungal colonization causes opportunistic infection that may manifest when the host's immune status deteriorates. The purpose of this study was to determine the prevalence of fungal colonization in immunocompromised subjects compared to healthy controls.
- Conditions
- Colonization, Asymptomatic
- Being tested
- nasal irrigation
- Keywords
- colonization, microbiota, fungi, immunocompromised
- Medical subject headings
- Asymptomatic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal irrigationOther
regular saline nasal rinse
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Not described | |
| immunocompromised subjects | Not described Receives: Other: nasal irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
nasal lavage pooled fungal microbiota
Measured: 1 month
Secondary outcomes (1)
nasal lavage aspergillus qPCR
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start20 Aug 2018
- Primary completion20 Jul 2020
- Study completion27 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonization, AsymptomaticStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231499
- Sponsor's protocol ID
- CE18237B
- Status last verified
- Jan 2022
- First submitted
- 30 Jan 2022
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host Immunity and Nasal Fungal Colonization
- ClinicalTrials.gov ID
- NCT05231499
- Acronym / sponsor ID
- CE18237B
- Conditions
- Colonization, Asymptomatic
- Keywords
- colonization, microbiota, fungi, immunocompromised
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 27 Jul 2020 (actual)
- First posted
- 9 Feb 2022 (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.
Fungal colonization causes opportunistic infection that may manifest when the host's immune status deteriorates. The purpose of this study was to determine the prevalence of fungal colonization in immunocompromised subjects compared to healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | – |
| immunocompromised subjects | – | Other: nasal irrigation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Immunocompromised subjects have rhinosinusitis or not using nasal irrigation or not using nasal irrigation
Key inclusion criteria (2 listed)
- Immunocompromised subjects included those who had known risk factors for fungal infection, including malignant diseases, diabetes, autoimmune disorders, renal or hepatic insufficiency, organ transplantation, or use of immunosuppressants
- Healthy volunteers had neither sinonasal symptoms nor nasal endoscopic inflammation.
Key exclusion criteria (1 listed)
- Patients were excluded if they were under 20 years old, were receiving antifungal medication, or were pregnant.
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 |
|---|---|---|
| nasal irrigationregular saline nasal rinse | Other | immunocompromised subjects |
Primary outcome
nasal lavage pooled fungal microbiota
Time frame: 1 month
1 secondary outcome
nasal lavage aspergillus qPCR
Time frame: 1 month
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 9 Feb 2022.
- 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 Colonization, Asymptomatic, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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 9 Feb 2022. 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 Taiwan. 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?
nasal lavage pooled fungal microbiota (time frame: 1 month). 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 9 Feb 2022.