Drug Provocation Test (DPT) to Paracetamol

NCT ID: NCT03771118

Last Updated: 2020-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

498 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-12-30

Brief Summary

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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).

Detailed Description

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Conditions

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Drug Hypersensitivity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal DEMOLY, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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University hospital of Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL18_0434

Identifier Type: -

Identifier Source: org_study_id

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