Clinical trial NCT03173053: S. Aureus Decolonization in HPN Patients.
Official title: Long-term StaphyloCoccus Aureus decolonizAtion in Patients on Home parenteRal nutRition: a randomIzed multicEnter tRial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Staphylococcus Aureus
Motility Disorder
Keywords: S. aureus
Home Parenteral Nutrition
Intestinal failure
Eradication
Decolonization
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: University College, London
First posted: 2017-06-01
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized controlled, open label superiority trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients totally eradicated for S. aureus during one year
timeFrame: One year
Secondary outcomes:
measure: Proportion of patients totally eradicated after one year
timeFrame: One year
measure: Developing long-term antimicrobial resistance
timeFrame: 6 and 12 months
measure: Incidence of S. aureus infections
timeFrame: Every 3 months during one year
measure: Overall incidence of infections
timeFrame: Every three months during one year
measure: Number of catheter removals
timeFrame: One year
measure: Mortality
timeFrame: One year
measure: S. aureus transmission
timeFrame: One year
measure: Patient compliance
timeFrame: Every three months during one year
measure: Adverse events
timeFrame: Every three months during one year
measure: Predictors for infections and treatment outcome
timeFrame: One year
measure: Health related quality of life
timeFrame: 0, 6 and 12 months
measure: Healthcare related costs.
timeFrame: One year
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Nijmegen
country: Netherlands
facility: Radboud UMC
state: Gelderland
city: Amsterdam
country: Netherlands
facility: AMC
state: Noord-Holland
Study officials:
affiliation: Sponsor GmbH
name: Joost PH Drenth, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Gompelman M, Wouters Y, Kievit W, Hopman J, Wertheim HF, Bleeker-Rovers CP, Wanten GJA. Long-term Staphylococcus aureus decolonization in patients on home parenteral nutrition: study protocol for a randomized multicenter trial. Trials. 2018 Jun 28;19(1):346. doi: 10.1186/s13063-018-2732-2.