- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02535793
Characterisation of Occupational Allergy to Drosophila (DROSOALLERG)
April 11, 2016 updated by: University Hospital, Montpellier
Allergy is a very common problem and can be a handicap in everyday life, specially when symptoms occur at work place.
Some persons working with drosophila developed respiratory symptoms.
Investigators tried to analyze if these manifestations could be due to a specific allergy to drosophila.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To do so, investigators invited laboratory workers who presented any symptoms in presence of drosophila to undergo skin prick tests in order to determine if a specific sensibilization to drosophila exists.
Then, a blood sample is taken from these persons to research specific IgE directed against drosophila.
By this way, investigators hope determine if a specific allergy to drosophila exists, its characteristics as prevalence, symptoms, populations concerned...in order to better protect laboratory workers and prevent allergy incidence.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France, 34295
- Hôpital Arnaud de Villeneuve
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- major males or females (aged <68) who work in laboratory with drosophila in Montpellier (France)
- clinical symptoms in presence of drosophila
- The subject must be affiliated to a social security scheme
- Provision of informed consent prior to any study specific procedures
Exclusion Criteria:
- The patient has indicated against (or incompatible drug combination) concerning the implementation of a prick test
- antihistamine cure in progress
- Inability to understand the nature and goals of the study and / or communication difficulties with the investigator
- No affiliation to a French social security recipient or not such a scheme
- Major protected by law (guardianship, curator or under judicial protection)
- deprivation of liberty by judicial or administrative decision
- Increased likelihood of non compliance to the protocol or abandonment under study
- pregnancy or breastfeeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: laboratory workers with symptoms in presence of drosophila
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with positive prick test to drosophila
Time Frame: The day of inclusion
|
Prick tests : measuring the size of the skin reaction (wheal) after prick tests with drosophila.
A wheal measuring more than 4 millimeters in diameter sign a sensitization to drosophila.
Then, a blood sample is collected in order to measure specific drosophila IgE rate
|
The day of inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survey to analyse risk factors for allergy to drosophila
Time Frame: The day of inclusion
|
analysis of professional (attended institute, time from start working with drosophila, type of animal manipulation (species, living, dead, DNA, protein) use of protection,) or personal factors (age, gender, others allergies, treatment used) which could lead to allergic reaction to drosophila
|
The day of inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
August 20, 2015
First Submitted That Met QC Criteria
August 26, 2015
First Posted (Estimate)
August 31, 2015
Study Record Updates
Last Update Posted (Estimate)
April 12, 2016
Last Update Submitted That Met QC Criteria
April 11, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- UF 9410
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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