Drug AllergyMDHNCT03784482
Multiple Drug Hypersensitivity Syndrome
An observational study of Drug Allergy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Background: Multiple drug hypersensitivity syndrome (MDH) is defined as confirmed drug hypersensitivity reactions (DHRs) to at least 2 chemically and pharmacologically unrelated drugs. Reports of MDH are scarce and poorly specified and studies which diagnose MDH on the basis of positive allergy tests are lacking. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug Allergy
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2018to 31 Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient consulting in our allergy unit for a suspicion of drug hypersensitivity and who underwent diagnostic drug allergy testing
Who may be able to join
- Patients who consulted at our allergy clinic (University Hospital of Montpellier, France)
- Between September 1996 and February 2018 with a clinical history suggestive of DHR
- Who completed a tailored drug allergy work-up, (including a drug allergy questionnaire, skin tests (STs) and drug provocation tests (DPTs)) and were diagnosed with MDH.
Who cannot join
- the DHR was due to a single component contained in 2 different drug formulations
- in composed drugs;
- there was possible cross-reactivity between the responsible drugs; (iv) the patient had positive but non standardized nor validated (i.e. possibly irritant)
- these STs were followed by a negative DPT;
- DPTs with placebo were positive; (vii) doubtful tests were repeated and eventually considered negative;
- a single DHR was associated with one or more non-drug related contact allergies;
- DPTs elicited subjective manifestations (i.e., isolated pruritus, headache, isolated abdominal pain);
- non-specific histamine release was suspected (e.g., chronic spontaneous - desensitization, rather than a diagnostic work-up was preferred in order to meet the urgent therapeutic needs of individual patients (HIV infected patients, cardiac patients).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple Drug Hypersensitivity Syndrome in a Large Database
Background: Multiple drug hypersensitivity syndrome (MDH) is defined as confirmed drug hypersensitivity reactions (DHRs) to at least 2 chemically and pharmacologically unrelated drugs. Reports of MDH are scarce and poorly specified and studies which diagnose MDH on the basis of positive allergy tests are lacking.
Objective: To evaluate retrospectively the frequency and characteristics of MDH patients in a large database.
Methods: All the patients who consulted and were tested in our Allergy Unit between September 1996 and February 2018, with confirmed MDH will be included. Clinical history and allergy work-up results will be extracted from our Drug Allergy and Hypersensitivity Database (DAHD). The frequency of MDH will be calculated, MDH patients will be described, the most frequent associations of DHRs will be identified and analysed.
- Conditions
- Drug Allergy
- Keywords
- Multiple Drug Hypersensitivity, drug hypersensitivity, antibiotics, drug provocation tests, skin tests
- Medical subject headings
- Drug Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure retrospectively the frequency of MDH patients in our database.
The frequency of MDH patients (percentage) in the allergic group of patients will be calculated as the number of MDH patients divided by the number of monoallergic patients (frequency of MDH patients in allergic population)
Measured: 1 day
To measure retrospectively the frequency of MDH patients in our database
The frequency of MDH in common population will be calculated by will be calculated as the number of MDH patients divided by the number of patients that underwent diagnostic drug allergy testing within the same time frame (frequency of MDH patients in the whole population
Measured: 1 day
Secondary outcomes (3)
To describe the MDH population, identify the most frequent associations of DHR
In this MDH patients population we will : Count the number of female and male patient according to their sex (No unit)
Measured: 1 day
To describe the MDH population, identify the most frequent associations of DHR
In this MDH patients population we will : Most frequent associations of DHR (No unit)
Measured: 1 day
To describe the MDH population, identify the most frequent associations of DHR
In this MDH patients population we will : Count and classify the different form of DHR according to their severity with the Ring and Messsmer and Regiscar study group scoring. (No unit) (ex: number of patient with grade III anaphylaxis or number of patient with DRESS syndrome )
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start20 Dec 2018
- Primary completion30 Jun 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AllergyStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal DEMOLY, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784482
- Sponsor's protocol ID
- RECHMPL18_0478
- Acronym
- MDH
- Status last verified
- Nov 2019
- First submitted
- 10 Dec 2018
- Last updated
- 19 Nov 2019
- 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 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Drug Hypersensitivity Syndrome in a Large Database
- ClinicalTrials.gov ID
- NCT03784482
- Acronym / sponsor ID
- MDH / RECHMPL18_0478
- Conditions
- Drug Allergy
- Keywords
- Multiple Drug Hypersensitivity, drug hypersensitivity, antibiotics, drug provocation tests, skin tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 24 Dec 2018 (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.
Background: Multiple drug hypersensitivity syndrome (MDH) is defined as confirmed drug hypersensitivity reactions (DHRs) to at least 2 chemically and pharmacologically unrelated drugs. Reports of MDH are scarce and poorly specified and studies which diagnose MDH on the basis of positive allergy tests are lacking.
Objective: To evaluate retrospectively the frequency and characteristics of MDH patients in a large database.
Methods: All the patients who consulted and were tested in our Allergy Unit between September 1996 and February 2018, with confirmed MDH will be included. Clinical history and allergy work-up results will be extracted from our Drug Allergy and Hypersensitivity Database (DAHD). The frequency of MDH will be calculated, MDH patients will be described, the most frequent associations of DHRs will be identified and analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient consulting in our allergy unit for a suspicion of drug hypersensitivity and who underwent diagnostic drug allergy testing
Key inclusion criteria (3 listed)
- Patients who consulted at our allergy clinic (University Hospital of Montpellier, France)
- Between September 1996 and February 2018 with a clinical history suggestive of DHR
- Who completed a tailored drug allergy work-up, (including a drug allergy questionnaire, skin tests (STs) and drug provocation tests (DPTs)) and were diagnosed with MDH.
Key exclusion criteria (8 listed)
- the DHR was due to a single component contained in 2 different drug formulations
- in composed drugs;
- there was possible cross-reactivity between the responsible drugs; (iv) the patient had positive but non standardized nor validated (i.e. possibly irritant)
- these STs were followed by a negative DPT;
- DPTs with placebo were positive; (vii) doubtful tests were repeated and eventually considered negative;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To measure retrospectively the frequency of MDH patients in our database.
Time frame: 1 day
The frequency of MDH patients (percentage) in the allergic group of patients will be calculated as the number of MDH patients divided by the number of monoallergic patients (frequency of MDH patients in allergic population)
To measure retrospectively the frequency of MDH patients in our database
Time frame: 1 day
The frequency of MDH in common population will be calculated by will be calculated as the number of MDH patients divided by the number of patients that underwent diagnostic drug allergy testing within the same time frame (frequency of MDH patients in the whole population
3 secondary outcomes
To describe the MDH population, identify the most frequent associations of DHR
Time frame: 1 day
To describe the MDH population, identify the most frequent associations of DHR
Time frame: 1 day
To describe the MDH population, identify the most frequent associations of DHR
Time frame: 1 day
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 Nov 2019.
- 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.
Pascal DEMOLY, MD, PhD principal investigator
University Hospital, Montpellier
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 Drug Allergy, run by University Hospital, Montpellier 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 8 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 Nov 2019. 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?
To measure retrospectively the frequency of MDH patients in our database. (time frame: 1 day). 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 Nov 2019.