NCT02839551

Brief Summary

Drug provocation tests (DPT) are widely in case of suspicion of drug hypersensitivity (and in the absence of contraindications), but there are no standardized protocols and most groups use hypothesis (clinically-driven) protocols. investigators used 20 year experience in drug hypersensitivity to analyse retrospectively 171 patients (accounting for 182 positive DPT to beta-lactams). Using survival analysis, they identified optimal doses to include in a data-driven protocol. This data-driven protocol will be applied to new prospective patients, to test its safety and benefits (gain in time, hospital and patient benefits).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2021

Completed
Last Updated

September 30, 2025

Status Verified

December 1, 2021

Enrollment Period

5.5 years

First QC Date

July 18, 2016

Last Update Submit

September 24, 2025

Conditions

Drug Hypersensitivity

Keywords

BetalactamsDrug hypersensitivityDrug provocation testReactive dose

Outcome Measures

Primary Outcomes (1)

  • Assessment of the new simplified drug provocation test

    Assessment of the non inferiority of the new drug provocation test compared to the present drug provocation test

    up to 1 hour

Study Arms (1)

Simplified drug provocation test

EXPERIMENTAL

Assessment of the Hypersensitivity to betalactams by simplified drug provocation test

Procedure: simplified drug provocation test

Interventions

simplified drug provocation testPROCEDURE

Assessment of the Hypersensitivity to betalactams by simplified drug provocation test

Simplified drug provocation test

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with positive Drug Provocation Test (DPT) to beta-lactams

You may not qualify if:

  • contra-indications to DPT
  • refusal of participation
  • vulnerable patients according to French regulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Montpellier

Montpellier, France, 34295, France

Location

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 21, 2016

Study Start

May 4, 2016

Primary Completion

November 16, 2021

Study Completion

November 16, 2021

Last Updated

September 30, 2025

Record last verified: 2021-12

Locations

FR(1)