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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03852342
Other study ID # RECHMPL18_0344
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 10, 2018
Est. completion date March 20, 2019

Study information

Verified date September 2018
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Peanut allergy is a growing public health problem in developed countries with more and more hospitalizations for anaphylaxis. It has been determined that sensitization to certain peanut proteins such as rAra h 2, is predictive of allergy and could predict the severity of reaction (anaphylaxis) during Oral food challenges (OFC). So far, consensual threshold for cutaneous test and IgE as predictor in the positivity of OFC have not been determined. Identification of reactive doses for OFC and phenotype of patients would help to personalize management of patients subgroups, with an optimal security.


Recruitment information / eligibility

Status Completed
Enrollment 262
Est. completion date March 20, 2019
Est. primary completion date February 28, 2019
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility Inclusion criteria:

- Patients with a clinical suspicion of peanut allergy who underwent OFC to peanut

- Patients not objecting to participate in the study

- Men and women are included

Exclusion criteria:

• The patient refused to participate in the study

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France University hospital of Montpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reactive doses of peanut (mg) at which an allergic reaction appears in patients with positive peanut Oral Food Challenge An Oral Food Challenge consists in the ingestion of the suspected allergic food. The patient is given increased dose levels of this food throughout a day. The OFC is positive when the patient presents a clinical reaction (clinical symptoms linked to an allergic response) triggered by the food ingested.
We'll gather the data of all patients who came in our unit of Allergology and who had a positive peanut OFC.
The reactive dose is calculated from the total cumulative dose (mg) of peanut reached when the OFC peanut is considered positive.
The reactive dose is considered as a time dependent data and will be analyzed with survival data analysis methods.
The analyzed event is a positive OFC
1 day
Secondary Time between the reaction and the last administered dose Time between the reaction and the last administered dose 1 day
Secondary Identifying risk factors of peanut hypersensitivity To identify the risk factors, that remain significantly associated with a positive peanut OFC 1 day
Secondary Risk factors of anaphylaxis during a positive peanut OFC To identify, among the collected data on the patient's clinical history detailled below, the risk factors of occurrence of an anaphylactic reaction during peanut OFC.
Anaphylaxis is defined as a severe allergic reaction that appears quickly and has a fatal potential. It is usually characterized by the appearance of several signs and symptoms that can affect one or more systems of our body.
1 day
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