Eradication of methicillin-susceptible Staphylococcus aureus nasal carriage in patients undergoing dialysis: can fusidic acid be used as an alternative to mupirocin?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002223-25-BE

Enrollment

140

Registered

2015-06-04

Start date

2015-08-18

Completion date

Unknown

Last updated

2024-12-03

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

Conditions

persistent nasal Staphylococcus aureus carriage

Interventions

Trade Name: FUCIDIN 2%, ointment Product Name: Fucidin 2% (sodium fusidate) Pharmaceutical Form: Nasal ointment INN or Proposed INN: SODIUM FUSIDATE Other descriptive name: SODIUM FUSIDATE Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing chronic hemodialysis (> 18yrs) with persistant nasal MSSA carriage (confirmed on two separate swabs, with at least one week interval). 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: MRSA carriage, chronic ambulatory peritoneal dialysis, active infection treated with antistaphylococcal antibiotics

Design outcomes

Primary

Measure	Time frame
Main Objective: Can Fucidin(r) ointment (sodium fusicate) be used as an alternative decolonization strategy in patients with persistent MSSA carriage undergoing hemodialysis?;Secondary Objective: - Is recolonization (quickly) observed? - How frequently should patients be decolonized. - Is there emergence of resistance? - What are the risk factors for failure of decolonization;Primary end point(s): difference in eradication of MSSA carriage in the Fucidin-group vs. Bactroban-group;Timepoint(s) of evaluation of this end point: day 8, 10, 15, 60 and 90 (microbiologic evaluation)	—

Measure

Time frame

Main Objective: Can Fucidin(r) ointment (sodium fusicate) be used as an alternative decolonization strategy in patients with persistent MSSA carriage undergoing hemodialysis?;Secondary Objective: - Is recolonization (quickly) observed? - How frequently should patients be decolonized. - Is there emergence of resistance? - What are the risk factors for failure of decolonization;Primary end point(s): difference in eradication of MSSA carriage in the Fucidin-group vs. Bactroban-group;Timepoint(s) of evaluation of this end point: day 8, 10, 15, 60 and 90 (microbiologic evaluation)

—

Secondary

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

Countries

Belgium

Contacts

Public ContactCharlotte Verfaillie

AZ Sint Lucas

Charlotte.Verfaillie@azstlucas.be+329224 64 45

Outcome results

None listed

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