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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04547751
Other study ID # CHUBX 2018/27
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 6, 2020
Est. completion date February 5, 2021

Study information

Verified date April 2022
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study aims (i) to identify which substances leading to hospitalizations at Mayotte are also called "chimique" and (ii) to correlate these substances with clinical pictures in order to favor a better approach of the treatments.


Description:

The CEIP-A of Bordeaux (in charge of French overseas departments) has been commissioned by the MILD&CA in 2015 to reinforce the links between local caregivers and the addictoviligance's inquieries. In particular, the CEIP-A has been alerted about a drug called " chimique " in Mayotte, leading to many hospitalizations. Most of the patients are less than 18 year old or are young adulthoods. For all patients who have agreed to participate in this study, the remainder of the blood sample will be reused for a drop of blood on blotting paper; the remainder of the remainder will be stored in the heparinized tube. Medical data collected in the emergency department will also be collected. All the data will be analyzed by the pharmacology and toxicology laboratory of the Bordeaux University Hospital


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date February 5, 2021
Est. primary completion date February 5, 2021
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria: - Patients hospitalized in the Emergency Department of the Mayotte Hospital Center after taking a chemical or other psychoactive substance and for whom a blood test is required; - Age = 14 years. Exclusion Criteria: - Patient without parental authority for minor patients aged 14yrs; Patient not included in the exception article 59 of the law of January 6th, 1978 modified for patient aged 15yrs and older

Study Design


Related Conditions & MeSH terms


Intervention

Other:
targeted high-resolution mass spectrometry
difference between the number of new substances identified using targeted analysis by liquid chromatography coupled with high-resolution mass spectrometry versus using targeted analysis. "narcotics-new substance" by liquid chromatography coupled with tandem mass spectrometry

Locations

Country Name City State
France CH Mayotte Mayotte

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Bordeaux ARS (Agence Régionale de Santé) Mayotte

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of new substances identified number of new substances identified Baseline
Secondary Active ingredients found Number of active ingredients found (including new substances Baseline
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