Interaction between S. aureus and other bacteria in the nose

Phase 1

• Conditions: S. aureus carriage; Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]

• Registration Number: EUCTR2018-002119-81-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-20
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

- Volunteers must be over 18 years old
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 175
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Employee of the Erasmus MC, Rotterdam
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To identify nasal microbial communities associated with S. aureus carriage and to study the influence over time of S. aureus targeted decolonization treatment on these microbial communities.;Secondary Objective: To investigate the time of recolonization by S. aureus (MSSA/MRSA) after decolonization in relation to the nasal microbiome and if so, whether this is recolonization with the same (own) strain or a newly acquired different strain.;Primary end point(s): The degree of change in microbiome composition over time after S. aureus decolonisation therapy;Timepoint(s) of evaluation of this end point: End of trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable