- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04547751
Hospitalisations of Teenagers and Young Adulthoods in Mayotte After Consumption of an Illegal Drug Called " Chimique ", Which Substances Are Incriminated ? : HOMACHI (HOMACHI)
April 11, 2022 updated by: University Hospital, Bordeaux
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mayotte, France, 97600
- CH Mayotte
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients hospitalized in the Emergency Department of the Mayotte Hospital Center after taking a chemical or other psychoactive substance
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adult
Patients aged 18yrs and older 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
|
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
|
Minor
Patients aged 14-17yrs and older 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of new substances identified
Time Frame: Baseline
|
number of new substances identified
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Active ingredients found
Time Frame: Baseline
|
Number of active ingredients found (including new substances
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2020
Primary Completion (Actual)
February 5, 2021
Study Completion (Actual)
February 5, 2021
Study Registration Dates
First Submitted
October 11, 2019
First Submitted That Met QC Criteria
September 10, 2020
First Posted (Actual)
September 14, 2020
Study Record Updates
Last Update Posted (Actual)
April 12, 2022
Last Update Submitted That Met QC Criteria
April 11, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2018/27
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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