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

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

Sponsors

Lead sponsor: Lund University

Source Lund University
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

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.

Overall Status Active, not recruiting
Start Date December 15, 2016
Completion Date June 30, 2020
Primary Completion Date June 30, 2020
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Infection frequency Two years
Secondary Outcome
Measure Time Frame
Hospital admittance Two years
Antibiotic prescription Two years
Death Two years
Enrollment 61
Condition
Intervention

Intervention type: Drug

Intervention name: Chlorhexidine Topical

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.

Arm group label: PWID colonized with S aureus

Eligibility

Criteria:

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

Exclusion Criteria: No

-

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Maria Josephson, MD Study Director VO Infektionssjukdomar SUS
Verification Date

May 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: PWID colonized with S aureus

Arm group type: Other

Description: Repeated chlorhexidin showers for PWID colonized with S aureus

Patient Data No
Study Design Info

Intervention model: Crossover Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov