Trials / Completed
CompletedNCT03771118
Drug Provocation Test (DPT) to Paracetamol
Construction and Validation of a Simplified Provocation Test for the Diagnosis of Paracetamol Hypersensitivity
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 498 (actual)
- Sponsor
- University Hospital, Montpellier · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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). 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
Timeline
- Start date
- 2018-12-01
- Primary completion
- 2019-12-01
- Completion
- 2019-12-30
- First posted
- 2018-12-10
- Last updated
- 2020-03-10
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03771118. Inclusion in this directory is not an endorsement.