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

People Who Inject Drugs; Longitudinal Staphylococcus Aureus Colonization Pattern and the Impact on Infection Frequency by Regular Showers With Chlorhexidine

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

1. Can repeated skin wash with chlorhexidine decrease infection frequency among PWID?
2. Is the longitudinal S. aureus colonization pattern associated with infection prevalence among PWID?
3. Can the risk of S. aureus-infections be predicted by quantification of bacterial level in anterior nares, throat, perineum or skin lesions/eczema?
4. 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.

Study Overview

• Status: Completed
• Conditions: Intravenous Drug Abuse, S Aureus Colonization
• Intervention / Treatment: Drug: Chlorhexidine Topical

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

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

Description

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

Exclusion Criteria: No

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PWID colonized with S aureus; Repeated chlorhexidin showers for PWID colonized with S aureus	Drug: Chlorhexidine Topical; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection frequency	Infections are regularly evaluated through interviews and Medical record reviews	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital admittance	Evaluated through medical records	Two years
Antibiotic prescription	Evaluated through medical records	Two years
Death	Evaluated through medical records	Two years

Collaborators and Investigators

• Sponsor: Lund University
• Investigators: Study Director: Maria Josephson, MD, VO Infektionssjukdomar SUS

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2016
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: infection; chlorhexidine; colonization; PWID; S aureus
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Substance Abuse, Intravenous; Infections; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers

Drug and device information, study documents

• 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