Skip to main content
OpenTrials
Completed

NCT Number: NCT04550767

: Bacterial Infections in Injecting Drug Users

Bacterial infections in people who inject psychoactive substances

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34290, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Types of bacterial infections

    Time frame: 1 day

    Types of bacterial infections : local or systemic:

  2. Psychoactive substances involved in each type of bacterial infections

    Time frame: 1 day

    Psychoactive substances involved in each type of bacterial infections

  3. Types of injections in each type of infections

    Time frame: 1 day

    Types of injections in each type of infections

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Bacterial Infections in People Who Inject Psychoactive Substances

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Sep 16, 2020
Registry last updated
Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.