: Bacterial Infections in Injecting Drug Users

Bacterial Infection Clinical Trial

Official title:

Bacterial Infections in People Who Inject Psychoactive Substances

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04550767
• Other study ID #: RECHMPL20_0523
• Status: Completed
• Start date: January 17, 2012
• Est. completion date: January 1, 2019

Study information

• Verified date: September 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Bacterial infections in people who inject psychoactive substances

Description:

In context of an increase of bacterial infections in people who inject psychoactive substances (PS) all around the world and a lack of available scientific data, the investigators decided to set up a descriptive study on bacterial infection types and determinants in Injection Drug Users (IDUs).

Through a multidisciplinary approach between hospital departments (e.g. infectious diseases, emergency and addictology), the local addiction management and liaison team (ELSA) and the regional addictovigilance center, data were collected on appearance and course of bacterial infections in IDUs hospitalized at Montpellier University Hospital, France.

This study aims to provide medical data in order to better understand those infections and their determinants and provide information for potential future more specific observational studies.

The regional addictovigilance center is a member of the French Addictovigilance Network, which was established to monitor the potential for abuse and dependence of PS, and to provide information on the risk of addiction and advice for public health decision making, under the supervision of the French National Agency for Medicines and Health Products Safety. This surveillance system is principally based on spontaneous reporting by healthcare professionals and patients that is regulated by law. Collected data were extracted from those spontaneous reports (composed by data from the medical file*, DxCare or notification by medical team). First data were collected in 2012.

In addition, the investigators offered patients to fill in an anonymous questionnaire** on hygiene habits which was not mandatory and had no influence on treatment, and was offered during the ELSA team intervention (questions from the questionnaire are classical risk reduction question on injection and hygiene practices).

Main results are the description of the infections and injection practices. There is no control group per se as all included patients are IDUs and have a bacterial infection. But the investigators infection (such as abscess or skin and soft tissue) and those with a systemic infection. The two groups were established after the recruitment was completed. This comparative analysis is only performed in order to better understand the development of infections. Descriptive and comparative analyses was performed by the Department of Medical Information.

*Data collected :

• Age

• Sex

• Past history of bacterial infection linked to injection of a psychoactive substance

• HIV and HCV status

• Injected psychoactive substance

• Injection practices (frequency, route, location)

• Diagnosis

• Bacterial analysis

• Treatments and course

• Hygiene questionnaire (attached file)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: January 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Bacterial infection occurring in injection drug users and linked to injection

• Hospitalized at Montpellier University Hospital

Exclusion criteria:

• No injection

• No use of a psychoactive substance

• Viral or fungal infection

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections
• Communicable Diseases
• Infection

Locations

Country	Name	City	State
France	Uhmontpellier	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	Types of bacterial infections	Types of bacterial infections : local or systemic:	1 day
Primary	Psychoactive substances involved in each type of bacterial infections	Psychoactive substances involved in each type of bacterial infections	1 day
Primary	Types of injections in each type of infections	Types of injections in each type of infections	1 day