: Bacterial Infections in Injecting Drug Users

Bacterial Infections in People Who Inject Psychoactive Substances

Bacterial infections in people who inject psychoactive substances

Study Overview

• Status: Completed
• Conditions: Bacterial Infection

Detailed 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)

• Study Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34290
    • UHMontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population includes all injection drug users, hospitalized at Montpellier University Hospital for bacterial infection related to the injection of one or several psychoactive substance(s).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
local infections
systemic infections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Types of bacterial infections	Types of bacterial infections : local or systemic:	1 day
Psychoactive substances involved in each type of bacterial infections	Psychoactive substances involved in each type of bacterial infections	1 day
Types of injections in each type of infections	Types of injections in each type of infections	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Hélène Peyrière, PH, UH Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2012
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Risk reduction; Psychoactive substances; Psychoactive substance; Intravenous substance abuse; Injection drug user
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Bacterial Infections
• Other Study ID Numbers: RECHMPL20_0523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No