No registrations found.
ID
Source
Brief title
Health condition
S. aureus, staphylococcus aureus
Sponsors and support
Intervention
Outcome measures
Primary outcome
Microbiome composition of the nose
Secondary outcome
Not applicable
Background summary
Rationale: 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.
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.
Study population: A total of 70 healthy Dutch volunteers will be recruited to participate in the study. These volunteers will be grouped based on their S. aureus carrier status, either as carriers or noncarriers.
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.
Main study parameters/endpoints: Microbiome composition of the nose, to be analysed in relation to S. aureus carrier status and decolonization.
Study design
After a two-week screening period for S. aureus nasal carriage, eligible volunteers are included and followed for 6 months.
Intervention
5 day treatment with Bactroban 2% nasal ointment (mupirocin) and Hibiscrub 4% cutaneous solution (chlorhexidine gluconate) at the start of the study
Margreet C. Vos
Wytemaweg 80, Room Na-901k
Rotterdam 3015 CN
The Netherlands
0107033510
m.vos@erasmusmc.nl
Margreet C. Vos
Wytemaweg 80, Room Na-901k
Rotterdam 3015 CN
The Netherlands
0107033510
m.vos@erasmusmc.nl
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, consisting of mupirocin nasal ointment and chlorhexidine wash
- 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
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7254 |
| NTR-old | NTR7461 |
| CCMO | NL65791.078.18 |
| OMON | NL-OMON48845 |