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

Phase 1

• Conditions: persistent nasal Staphylococcus aureus carriage; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-002223-25-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-04
• Last Update Posted: 21 July 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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?<br>- How frequently should patients be decolonized.<br>- Is there emergence of resistance?<br>- 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 Outcome Measures

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