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Long-term StaphyloCoccus aureus decolonizAtion in patients on home parentRal nutRition: a randomized multicEnter tRial.

Long-term StaphyloCoccus aureus decolonizAtion in patients on home parentRal nutRition: a randomized multicEnter tRial. - S. aureus decolonization in HPN patients/CARRIER-trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44280
Enrollment
66
Registered
2017-09-11
Start date
2018-02-08
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

contamination with own skin bacteria S. aureus carriage

Interventions

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 wa
intestinal failure

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Patient is fully able to understand the nature of the proposed intervention. - Patient is diagnosed with intestinal failure and on HPN and/or fluid replacement - 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

Exclusion criteria: - Cannot be expected to comply with the trial plan (substance abuse, mental condition). - Pregnant or breastfeeding women. - Continuous exposure to MRSA (e.g. pig farmer). - Allergy for chlorhexidine and betadine. - No options for oral and/or topical antibiotics due to allergies and/or resistance. - Active S. aureus infection. - Currently on treatment with antibiotics active against S. aureus. - Decolonization (including mupriocin) treatment in the previous two months. - The presence of an unremovable nasal foreign body. - AST and ALT levels more than five times the upper limit of normal or liver failure.

Design outcomes

Primary

MeasureTime frame
Primary outcome: proportion of patients eradicated for S. aureus (nose, throat, rectum, exit-site catheter) during one year.

Secondary

MeasureTime frame
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.

Countries

Denmark, Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)