Interaction between S. aureus and other bacteria in the nose

Carriage of S. aureus and interaction with the nasal microbiome - MACOTRA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002119-81-NL

Enrollment

175

Registered

2018-06-20

Start date

2018-09-05

Completion date

Unknown

Last updated

2020-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S. aureus carriage

Interventions

Trade Name: Bactroban 2% Neuszalf 20 mg/g Pharmaceutical Form: Nasal ointment Trade Name: Hibiscrub Pharmaceutical Form: Cutaneous solution

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Netherlands

Contacts

Public ContactMedisch Ethische Toetsings Commissi

Erasmus MC

metc@erasmusmc.nl0031107033625

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026