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
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
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
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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