Chronic Spontaneous UrticariaNCT04314999
Frequency of Parasite Infestation in Patients With Chronic Spontaneous Urticaria
An observational study of Chronic Spontaneous Urticaria and Parasitic Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The goal of this study is to describe the prevalence and the type of parasite in patients with a chronic spontaneous urticaria as well as to describe the associations between parasitic disease and the characteristics of the patients, for example eosinophilia. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Chronic Spontaneous Urticaria, Parasitic Disease
- What is being tested?
- Examination of stool samples
- How many people
- 57 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2019to 30 Sep 2019
- 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 17 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients with a chric spontaneous urticaria who were being treated at the allergology of the university hospital Basel between the 1st of June and the 30th of September.
Who may be able to join
- Diagnosis of a chronic spontaneous urticaria
- Age: 17 years old and up
Who cannot join
- No diagnosis of a chronic spontaneous urticaria
- Age: younger than 17 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Häufigkeit Der Infestation Mit Parasiten Bei Patienten Mit Chronisch Spontaner Urtikaria, Eine Retrospektive Datenanalyse
The goal of this study is to describe the prevalence and the type of parasite in patients with a chronic spontaneous urticaria as well as to describe the associations between parasitic disease and the characteristics of the patients, for example eosinophilia.
- Conditions
- Chronic Spontaneous Urticaria, Parasitic Disease
- Being tested
- Examination of stool samples
- Keywords
- Chronic Spontaneous Urticaria, Parasitic disease
- Medical subject headings
- Chronic Urticaria, Parasitic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination of stool samplesDiagnostic test
Tests for diagnosis of parasitic diseases
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with a chronic spontaneous urticaria | Patients with a chronic spontaneous urticaria who were being treated at the allergology of the university hospital Basel between the 1st of June and the 30th of September Receives: Diagnostic Test: Examination of stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with parasite infestation
assess number of patients with chronic spontaneous urticaria that have a parasite infestation (Analysis of stool samples by the Swiss Tropical and Public Health Institute (TPH), Basel)
Measured: Patients with a chronic spontaneous urticaria that were treated at the University hospital basel between the 1st of June 2019 and the 30th of September 2019
Most common parasite subgroup
subtype determination from stool samples was performed by the Swiss TPH, Basel by polymerase chain reaction (PCR)
Measured: Patients with a chronic spontaneous urticaria that were treated at the University hospital basel between the 1st of June 2019 and the 30th of September 2019
Secondary outcomes (2)
Correlation between migration Background/ travel history of the patients and parasite infestation
examine travel history and migration background of patients
Measured: Patients with a chronic spontaneous urticaria that were treated at the University hospital basel between the 1st of June 2019 and the 30th of September 2019
Correlation between gastrointestinal complaints of the patients and parasite infestation
anamnesis of the patients
Measured: Patients with a chronic spontaneous urticaria that were treated at the University hospital basel between the 1st of June 2019 and the 30th of September 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Jun 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esther Steveling-Klein, Dr. med., Principal investigator, Allergology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314999
- Sponsor's protocol ID
- 2019-01953;sp20Steveling2
- Other IDs
- 2019
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Häufigkeit Der Infestation Mit Parasiten Bei Patienten Mit Chronisch Spontaner Urtikaria, Eine Retrospektive Datenanalyse
- ClinicalTrials.gov ID
- NCT04314999
- Acronym / sponsor ID
- 2019-01953;sp20Steveling2
- Conditions
- Chronic Spontaneous Urticaria, Parasitic Disease
- Keywords
- Chronic Spontaneous Urticaria, Parasitic disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 19 Mar 2020 (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.
The goal of this study is to describe the prevalence and the type of parasite in patients with a chronic spontaneous urticaria as well as to describe the associations between parasitic disease and the characteristics of the patients, for example eosinophilia.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with a chronic spontaneous urticaria | – | Diagnostic Test: Examination of stool samplesPatients with a chronic spontaneous urticaria who were being treated at the allergology of the university hospital Basel between the 1st of June and the 30th of September |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a chric spontaneous urticaria who were being treated at the allergology of the university hospital Basel between the 1st of June and the 30th of September.
Key inclusion criteria (2 listed)
- Diagnosis of a chronic spontaneous urticaria
- Age: 17 years old and up
Key exclusion criteria (2 listed)
- No diagnosis of a chronic spontaneous urticaria
- Age: younger than 17 years
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 |
|---|---|---|
| Examination of stool samplesTests for diagnosis of parasitic diseases | Diagnostic test | Patients diagnosed with a chronic spontaneous urticaria |
Primary outcome
Number of patients with parasite infestation
Time frame: Patients with a chronic spontaneous urticaria that were treated at the University hospital basel between the 1st of June 2019 and the 30th of September 2019
assess number of patients with chronic spontaneous urticaria that have a parasite infestation (Analysis of stool samples by the Swiss Tropical and Public Health Institute (TPH), Basel)
Most common parasite subgroup
Time frame: Patients with a chronic spontaneous urticaria that were treated at the University hospital basel between the 1st of June 2019 and the 30th of September 2019
subtype determination from stool samples was performed by the Swiss TPH, Basel by polymerase chain reaction (PCR)
2 secondary outcomes
Correlation between migration Background/ travel history of the patients and parasite infestation
Time frame: Patients with a chronic spontaneous urticaria that were treated at the University hospital basel between the 1st of June 2019 and the 30th of September 2019
Correlation between gastrointestinal complaints of the patients and parasite infestation
Time frame: Patients with a chronic spontaneous urticaria that were treated at the University hospital basel between the 1st of June 2019 and the 30th of September 2019
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 19 Mar 2020.
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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.
Esther Steveling-Klein, Dr. med. principal investigator
Allergology, University Hospital Basel
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 Chronic Spontaneous Urticaria and Parasitic Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 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 19 Mar 2020. 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 Switzerland. 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?
Number of patients with parasite infestation (time frame: Patients with a chronic spontaneous urticaria that were treated at the University hospital basel between the 1st of June 2019 and the 30th of September 2019). 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 19 Mar 2020.