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PWID; Longitudinal S Aureus Colonization Pattern and the Impact on Infection Frequency by Regular Showers With Chlorhexidine

Primary Purpose

Intravenous Drug Abuse, S Aureus Colonization

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Chlorhexidine Topical
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intravenous Drug Abuse, S Aureus Colonization focused on measuring PWID, S aureus, colonization, infection, chlorhexidine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants in a needle exchange program who are willing to undergo study procedures -

Exclusion Criteria: No

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    PWID colonized with S aureus

    Arm Description

    Repeated chlorhexidin showers for PWID colonized with S aureus

    Outcomes

    Primary Outcome Measures

    Infection frequency
    Infections are regularly evaluated through interviews and Medical record reviews

    Secondary Outcome Measures

    Hospital admittance
    Evaluated through medical records
    Antibiotic prescription
    Evaluated through medical records
    Death
    Evaluated through medical records

    Full Information

    First Posted
    May 6, 2019
    Last Updated
    April 21, 2022
    Sponsor
    Lund University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03940729
    Brief Title
    PWID; Longitudinal S Aureus Colonization Pattern and the Impact on Infection Frequency by Regular Showers With Chlorhexidine
    Official Title
    People Who Inject Drugs; Longitudinal Staphylococcus Aureus Colonization Pattern and the Impact on Infection Frequency by Regular Showers With Chlorhexidine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    December 15, 2016 (Actual)
    Primary Completion Date
    January 1, 2020 (Actual)
    Study Completion Date
    January 1, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lund University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    People who inject drugs (PWID) have increased risk of Staphylococcus aureus (S. aureus) colonization, skin and soft tissue infections (SSTI), and systemic infections like septicaemia and endocarditis. International research and data from Malmö needle exchange program (NEP) show a 60 - 70% lifetime SSTI prevalence. Longitudinal colonization pattern of S. aureus and its association with infection frequency among PWID is unknown. Cultures from the anterior nares, throat and perineum are used to indirectly assess S. aureus skin colonization. In PWID 28 - 45% are colonized in the nares, which increases risk of infections. Clinical significance of extra-nasal colonization, and persistent/intermittent colonization is uncertain. The S. aureus genome can be characterized by whole genome sequencing (WGS). Certain types are associated with abscesses and systemic infections. The infection pattern among PWID is unknown. S. aureus skin colonization level is decreased by chlorhexidine body wash and nasal mupirocin used as surgical prophylaxis and treatment of furunculosis. To our knowledge, disinfection effect on infections in PWID is not studied. However, the clinical impression is that severe infections have somewhat diminished since the NEP started distributing skin disinfectant tissues. RESEARCH QUESTIONS Can repeated skin wash with chlorhexidine decrease infection frequency among PWID? Is the longitudinal S. aureus colonization pattern associated with infection prevalence among PWID? Can the risk of S. aureus-infections be predicted by quantification of bacterial level in anterior nares, throat, perineum or skin lesions/eczema? Can different types of S. aureus be identified, that are associated with colonization or infection among PWID (by WGS)? METHODS AND TIME PHRAME Malmö NEP was established in 1986, and several studies assessing HIV, hepatitis and sociological questions have been conducted in this setting. In December 2016 continuous inclusion of 100 PWID for the actual study started at Malmö NEP. The study period is estimated to two years, with scientific papers expected for publication. During the first year of the study, mapping of S. aureus colonization pattern among all study participants is conducted by repeated sampling, clinical evaluation of eczemas, and interviews regarding infections. Every third month samples are collected from nares, throat, perineum and skin lesions. Semi quantification of S. aureus takes place at the microbiological research laboratory at Lund University. BBL CHROMagar Staph aureus-plates are used and incubated in 35oC air for 48h. S. aureus-colonies are identified and quantified manually by pink colour change and Pastorex. MALDI-TOF will be used in unclear cases. Disk-diffusion will be used for resistance determination. Bacterial isolates will be frozen to -70oC for later WGS. Intervention with chlorhexidine wash starts one year after inclusion for each study subject, and will continue for one additional year. Study participants with S aureus colonization will undergo regular showers with chlorhexidine (intervention group) at the needle exchange. In order to avoid bacterial resistance, muporicin will not be used. During the intervention, cultures, interviews and clinical evaluation will continue.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intravenous Drug Abuse, S Aureus Colonization
    Keywords
    PWID, S aureus, colonization, infection, chlorhexidine

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PWID colonized with S aureus
    Arm Type
    Other
    Arm Description
    Repeated chlorhexidin showers for PWID colonized with S aureus
    Intervention Type
    Drug
    Intervention Name(s)
    Chlorhexidine Topical
    Intervention Description
    In the Malmö needle exchange program, people who inject drugs (PWID) are repeatedly screened for S aureus colonization during one year. Those colonized will repeatedly shower with chlorhexidine during the following year. The infection frequency will be compared between the two periods.
    Primary Outcome Measure Information:
    Title
    Infection frequency
    Description
    Infections are regularly evaluated through interviews and Medical record reviews
    Time Frame
    Two years
    Secondary Outcome Measure Information:
    Title
    Hospital admittance
    Description
    Evaluated through medical records
    Time Frame
    Two years
    Title
    Antibiotic prescription
    Description
    Evaluated through medical records
    Time Frame
    Two years
    Title
    Death
    Description
    Evaluated through medical records
    Time Frame
    Two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants in a needle exchange program who are willing to undergo study procedures - Exclusion Criteria: No -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria Josephson, MD
    Organizational Affiliation
    VO Infektionssjukdomar SUS
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD will not be shared with other researchers

    Learn more about this trial

    PWID; Longitudinal S Aureus Colonization Pattern and the Impact on Infection Frequency by Regular Showers With Chlorhexidine

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