Staphylococcus Aureus, Motility Disorder
Conditions
Keywords
S. aureus, Home Parenteral Nutrition, Intestinal failure, Eradication, Decolonization
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.
Interventions
DRUGDoxycycline
tablet
DRUGTrimethoprim
tablet
tablet
DRUGClindamycin
tablet
DRUGClarithromycin
tablet
DRUGCiprofloxacin
tablet
DRUGFusidic Acid
tablet or ointment
DRUGRifampin
tablet
DRUGChlorhexidine
Mouthwash or bodywash
DRUGMupirocin
Nasal ointment
DRUGBetadine
Shampoo
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University College, London
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Multicenter, randomized controlled, open label superiority trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients totally eradicated for S. aureus during one year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | One year | Mortality based on data from electronic patient dossier |
| S. aureus transmission | One year | S. aureus transmission routes from caregiver to patient (measured with NGS). |
| Developing long-term antimicrobial resistance | 6 and 12 months | Long-term antimicrobial resistance at 6 and 12 months (measured with standard cultures and NGS) |
| Incidence of S. aureus infections | Every 3 months during one year | Incidence of S. aureus infections measured with (serious) adverse events forms every 3 months |
| Overall incidence of infections | Every three months during one year | Overall incidence and time to onset of infections measured with (serious) adverse events forms every 3 months |
| Number of catheter removals | One year | Number of catheter removals based on data from electronic patient dossier |
| Patient compliance | Every three months during one year | Patient compliance (measured with medication files, counting pills, trial-specific medication diary). |
| Adverse events | Every three months during one year | Adverse events (measured with (serious) adverse event forms every 3 months). |
| Predictors for infections and treatment outcome | One year | Predictors for infections and treatment failure/success (binominal regression analysis). |
| Health related quality of life | 0, 6 and 12 months | Generic health related quality of life (measured with a validated questionnaire (EQ5D-5L)). |
| Healthcare related costs. | One year | Cost-effectiveness analysis |
| Proportion of patients totally eradicated after one year | One year | Proportion of patients totally eradicated for S. aureus based on negative cultures performed after one year |
Countries
Denmark, Netherlands
Outcome results
None listed