S. Aureus Decolonization in HPN Patients.

Radboud University Medical Center63 enrolled

Overview

This trial focusses on identifying the most effective and safe long-term S. aureus carriage decolonization strategy in home parenteral nutrition patients. Half of the participants will receive a quick and short systemic antibiotic treatment combined with topical treatment, while the other half will receive only topical treatment on a periodic basis.

Patients on home parenteral nutrition (HPN) are exposed to a lifelong 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Staphylococcus Aureus Motility Disorder

Interventions

DoxycyclineDRUG

tablet

TrimethoprimDRUG

tablet

Sulfamethoxazole/trimethoprimDRUG

tablet

Clindamycin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is fully able to understand the nature of the proposed intervention. * Written informed consent by the patient before entering the trial. * Age ≥ 18 years. * Estimated life expectancy ≥ 1 year. * Patient colonized with S. aureus. Exclusion Criteria: * Cannot be expected to comply with the trial plan (substance abuse, mental condition). * Pregnant or breastfeeding women. * Continuous exposure to Methicillin-resistant S. aureus (MRSA; e.g. pig farmer). * Allergy for chlorhexidine and betadine. * No options for oral and/or topical antibiotics due to allergies. * Active S. aureus infection. * Currently on treatment with antibiotics active against S. aureus. * Decolonization (including mupirocin) treatment in the previous two months. * The presence of a nasal foreign body. * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) levels more than five times the upper limit of normal or liver failure.

Locations (4)

Aalborg Universitetshospital

Aalborg, Denmark

Rigshospitalet

Copenhagen, Denmark

Radboud UMC

Nijmegen, Gelderland, Netherlands

AMC

Amsterdam, North Holland, Netherlands

Outcomes

Primary Outcomes

Proportion of patients totally eradicated for S. aureus during one year

Totally eradicated is defined as 100% of all culture swabs (nose, throat, rectum), exit-site catheter and body regions on indication) being negative for S. aureus.

Time frame: One year

Secondary Outcomes

Proportion of patients totally eradicated after one year

Proportion of patients totally eradicated for S. aureus based on negative cultures performed after one year

Time frame: One year

Developing long-term antimicrobial resistance

Long-term antimicrobial resistance at 6 and 12 months (measured with standard cultures and NGS)

Time frame: 6 and 12 months

Incidence of S. aureus infections

Incidence of S. aureus infections measured with (serious) adverse events forms every 3 months

Time frame: Every 3 months during one year

Overall incidence of infections

Overall incidence and time to onset of infections measured with (serious) adverse events forms every 3 months

Time frame: Every three months during one year

Number of catheter removals

Number of catheter removals based on data from electronic patient dossier

Time frame: One year

Mortality

Mortality based on data from electronic patient dossier

Time frame: One year

S. aureus transmission

Data from ClinicalTrials.gov

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