Drug HypersensitivityParacetamolNCT03771118
Drug Provocation Test (DPT) to Paracetamol
An observational study of Drug Hypersensitivity, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Background : Paracetamol (acetaminophen) drug hypersensitivity reactions (DHR) are oonfirmed in about 10% of alleged cases. The diagnosis is made via an empirical drug provocation test (DPT). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug Hypersensitivity
- How many people
- 498 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2018to 30 Dec 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 to Paracetamol and who underwent DPT.
Who may be able to join
- Patients with a positive or negative DPT to paracetamol
Who cannot join
- Patients refusing to take part in the study
- Patient under 10 years old
Trial locations and contacts
1 site in 1 country.
France1 site
University hospital of Montpellier
Montpellier, Montpellier, 34295
About this study
Official title: Construction and Validation of a Simplified Provocation Test for the Diagnosis of Paracetamol Hypersensitivity
Background : Paracetamol (acetaminophen) drug hypersensitivity reactions (DHR) are oonfirmed in about 10% of alleged cases. The diagnosis is made via an empirical drug provocation test (DPT).
Objective: Detect eliciting dose thresholds during Paracetamol DPT in order to suggest optimal step doses and to identify variables and potential risk factors associated with Paracetamol hypersensitivity.
Methods:This retrospective study, using the survival analysis and the multivariate analysis, will comprise all patients who attended the allergy service of the University Hospital of Montpellier from 1996 till 2018 with a clinical history related to Paracetamol DHR, who underwent Paracetamol DPT and who gave their consent to be included in the study. The patients are selected from the Drug Allergy \& Hypersensitivity Database (DAHD).
- Conditions
- Drug Hypersensitivity
- Keywords
- Drug Hypersensitivity Reaction, Drug Provocation Test, Paracetamol, Reactive Doses, Reactive Times, Acetaminophen
- Medical subject headings
- Drug Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect of the reactive dose (RD)
The outcome measure of the RD : The dose that the patient reaches when the DPT is positive, divided by the total DPT dose for a given patient. This RD will be calculated for every patient with a positive DPT. New events (positive DPT) from one RD to another will be evaluated in number and severity.
Measured: 1 day
Secondary outcomes (1)
Measure is a positive DPT to paracetamol
Identifying clinical risk factors (Odds Ratio), using the binary logistic regression method, significantly associated with a positive Paracetamol DPT.
Age at reaction, sex, presence of asthma and atopy, type and chronology of the initial reaction will be evaluated as potential risk factors. Risk factors of anaphylaxis during DPT will also be calculated, using the same variables.
Potential variables to explain this measure will be introduced in a logistic model, in order to obtain crude and adjusted OR that could explain a positive DPT to paracetamol.
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 posted10 Dec 2018
- Study start1 Dec 2018
- Primary completion1 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug HypersensitivityStudies 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
- 498 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
- NCT03771118
- Sponsor's protocol ID
- RECHMPL18_0434
- Acronym
- Paracetamol
- Status last verified
- Mar 2020
- First submitted
- 13 Nov 2018
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghiordanescu IM, Ciocanea-Teodorescu I, Molinari N, Jelen A, Al-Ali O, Schrijvers R, Demoly P, Chiriac AM. Comparative Performance of 4 Penicillin-Allergy Prediction Strategies in a Large Cohort. J Allergy Clin Immunol Pract. 2024 Nov;12(11):2985-2993. doi: 10.1016/j.jaip.2024.07.012. Epub 2024 Jul 20.
PubMed 39038539
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Validation of a Simplified Provocation Test for the Diagnosis of Paracetamol Hypersensitivity
- ClinicalTrials.gov ID
- NCT03771118
- Acronym / sponsor ID
- Paracetamol / RECHMPL18_0434
- Conditions
- Drug Hypersensitivity
- Keywords
- Drug Hypersensitivity Reaction, Drug Provocation Test, Paracetamol, Reactive Doses, Reactive Times, Acetaminophen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 10 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 : Paracetamol (acetaminophen) drug hypersensitivity reactions (DHR) are oonfirmed in about 10% of alleged cases. The diagnosis is made via an empirical drug provocation test (DPT).
Objective: Detect eliciting dose thresholds during Paracetamol DPT in order to suggest optimal step doses and to identify variables and potential risk factors associated with Paracetamol hypersensitivity.
Methods:This retrospective study, using the survival analysis and the multivariate analysis, will comprise all patients who attended the allergy service of the University Hospital of Montpellier from 1996 till 2018 with a clinical history related to Paracetamol DHR, who underwent Paracetamol DPT and who gave their consent to be included in the study. The patients are selected from the Drug Allergy \& Hypersensitivity Database (DAHD).
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 to Paracetamol and who underwent DPT.
Key inclusion criteria (1 listed)
- Patients with a positive or negative DPT to paracetamol
Key exclusion criteria (2 listed)
- Patients refusing to take part in the study
- Patient under 10 years old
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
Detect of the reactive dose (RD)
Time frame: 1 day
The outcome measure of the RD : The dose that the patient reaches when the DPT is positive, divided by the total DPT dose for a given patient. This RD will be calculated for every patient with a positive DPT. New events (positive DPT) from one RD to another will be evaluated in number and severity.
1 secondary outcome
Measure is a positive DPT to paracetamol
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 12 Jun 2026.
- Results publication: PubMed 39038539Ghiordanescu IM, Ciocanea-Teodorescu I, Molinari N, Jelen A, Al-Ali O, Schrijvers R, Demoly P, Chiriac AM. Comparative Performance of 4 Penicillin-Allergy Prediction Strategies in a Large Cohort. J Allergy Clin Immunol Pract. 2024 Nov;12(11):2985-2993. doi: 10.1016/j.jaip.2024.07.012. Epub 2024 Jul 20.
- 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 Hypersensitivity, 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 1 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 12 Jun 2026. 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?
Detect of the reactive dose (RD) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03771118, which also lists 1 linked publication.
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 12 Jun 2026.