To identify nasal microbial communities associated with Staphylococcus aureus carriage and study the influence over time of S. aureus-targeted decolonization treatment on these microbial communities
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Skin and subcutaneous tissue disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Microbiome composition of the nose, to be analysed in relation to S. aureus
carrier status and decolonization.
Secondary outcome
NA
Background summary
This study will investigate the interaction between host nasal microbiome and
Staphylococcus aureus to elicit the influence of host factors on success of
dominant MRSA clones.
Study objective
To identify nasal microbial communities associated with Staphylococcus aureus
carriage and study the influence over time of S. aureus-targeted decolonization
treatment on these microbial communities
Study design
Prospective interventional cohort study with 2 groups
Intervention
After inclusion and determination of carrier status, all volunteers will be
treated with Mupirocin (Bactroban) 2% nasal ointment and Chlorhexidine
gluconate (Hibiscrub®) 4% cutaneous body wash solution within the product
indication and in accordance with local clinical practice.
Study burden and risks
Risks and burden are considered to be minimal. The nasal swabs and microbiome
samples are considered non-invasive procedures and can cause no harm for the
patient. Additionally, volunteers will be asked to fill out a questionnaire
regarding risk factors for acquisition of Staphylococcus aureus and report
changes during the study period. Medical products used in the intervention are
registered at the CBG, used topically and used within the indication. The risk
for usage of these medical products is considered equal for both S. aureus
carriers as noncarriers. Overall risk for usage of these medical products is
considered low, as the study population is healthy and the intervention
medication has been used worldwide for years now without serious adverse
reactions.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
Volunteers must be over 18 years old
Exclusion criteria
- Employee of the Erasmus MC
- Intermittent carrier of Staphylococcus aureus
- Use of drugs influencing microbiome in 3 months prior to the study period
i.e. antibiotics, antiparasitics or antifungals
- Regular use of commercial probiotics in 3 months prior to the study period
- Known allergy to components of the intervention treatment (see Ch 5.1)
- Pregnant and breastfeeding women, due to limited scientific evidence on
adverse effects of mupirocin treatment during pregnancy and breastfeeding.
- Known chronic diseases affecting the immune system (such as diabetes
mellitus, renal insufficiency, COPD, heart diseases, immunocompromised status
(HIV, AIDS), skin diseases such as severe eczema or use of immunosuppressant
drugs
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-002119-81-NL |
| CCMO | NL65791.078.18 |
| OMON | NL-OMON26095 |