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Drug Provocation Test (DPT) to Paracetamol

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Drug Hypersensitivity

Study type

Observational

Funder types

Other

Identifiers

NCT03771118
RECHMPL18_0434

Details and patient eligibility

About

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).

Enrollment

498 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with a positive or negative DPT to paracetamol

Exclusion criteria

  • Patients refusing to take part in the study
  • Patient under 10 years old

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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