Bacterial InfectionNCT04550767
: Bacterial Infections in Injecting Drug Users
An observational study of Bacterial Infection, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Bacterial infections in people who inject psychoactive substances Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infection
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2012to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Bacterial infection occurring in injection drug users and linked to injection
- Hospitalized at Montpellier University Hospital
Who cannot join
- No injection
- No use of a psychoactive substance
- Viral or fungal infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bacterial Infections in People Who Inject Psychoactive Substances
Bacterial infections in people who inject psychoactive substances
Read the 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)
- Conditions
- Bacterial Infection
- Keywords
- Psychoactive substance, Intravenous substance abuse, Injection drug user, Risk reduction, Psychoactive substances
- Medical subject headings
- Bacterial Infections, Substance Abuse, Intravenous, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| local infections | local infections | |
| systemic infections | systemic infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Types of bacterial infections
Types of bacterial infections : local or systemic:
Measured: 1 day
Psychoactive substances involved in each type of bacterial infections
Psychoactive substances involved in each type of bacterial infections
Measured: 1 day
Types of injections in each type of infections
Types of injections in each type of infections
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start17 Jan 2012
- Primary completion1 Dec 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Peyrière, PH, Study director, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550767
- Sponsor's protocol ID
- RECHMPL20_0523
- Status last verified
- Sep 2020
- First submitted
- 3 Sep 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Infections in People Who Inject Psychoactive Substances
- ClinicalTrials.gov ID
- NCT04550767
- Acronym / sponsor ID
- RECHMPL20_0523
- Conditions
- Bacterial Infection
- Keywords
- Psychoactive substance, Intravenous substance abuse, Injection drug user, Risk reduction, Psychoactive substances
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 17 Jan 2012 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bacterial infections in people who inject psychoactive substances
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local infections | – | –local infections |
| systemic infections | – | –systemic infections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Bacterial infection occurring in injection drug users and linked to injection
- Hospitalized at Montpellier University Hospital
Key exclusion criteria (3 listed)
- No injection
- No use of a psychoactive substance
- Viral or fungal infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Types of bacterial infections
Time frame: 1 day
Types of bacterial infections : local or systemic:
Psychoactive substances involved in each type of bacterial infections
Time frame: 1 day
Psychoactive substances involved in each type of bacterial infections
Types of injections in each type of infections
Time frame: 1 day
Types of injections in each type of infections
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène Peyrière, PH study director
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infection, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Types of bacterial infections (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.