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BACKGROUND:

Patients on home parenteral nutrition (HPN) are exposed to a life-long risk of developing S. aureus bacteremia (SAB). SAB pose a threat to both catheter and patient survival and may lead to a permanent loss of vascular access. S. aureus carriage eradication has proven successful in prevention of S. aureus infections. S. aureus decolonization is a key strategy to maintain venous access and avoid hospitalization.

OBJECTIVE:

To identify the most effective and safe long-term S. aureus carriage decolonization strategy in HPN patients. Ultimately this will lead to less antimicrobial resistance, less catheter removals and lower mortality rates. Also, other chronic patientgroups may benefit from this trial as well, such as hemodialysis patients.

STUDY DESIGN:

Randomized multicenter trial in the Netherlands and Denmark.

POPULATION:

Adult HPN patients carrying S. aureus.

INTERVENTION:

Patients will be randomized to a search and destroy (SD) strategy: a quick and short, systemic antibiotic treatment (nasal mupirocin ointment, oropharyngeal chlorhexidine rinse, chlorhexidine body wash and systemic antibiotics) or a continuous suppression (CS) strategy: a repeated chronic topical treatment (nasal mupirocin ointment, oropharyngeal chlorhexidine rinse and chlorhexidine body wash).

OUTCOME MEASURE:

Primary outcome: proportion of patients eradicated for S. aureus (nose, throat, rectum, exit-site catheter) during one year. Secondary outcomes: long-term antimicrobial resistance, adverse events, patient compliance, incidence of (S. aureus) infections, catheter removals, mortality rates, S. aureus transmission routes, quality of life and costs.

SAMPLE SIZE:

The expected efficacy of the CS group is 55% and 77% in the SD group. With the following settings: binary outcome, superiority trial, power of 80% and alpha of 5%, 138 patients (2x69) are required.

TIME SCHEDULE:

First patient will be included in Q1 of 2017 and will be followed for one year. The estimated end date will be in Q4 of 2018.

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