TerminatedNot Applicable

S. Aureus Decolonization in HPN Patients.

Stopped: Results interim-analysis

Denmark, Netherlands63 participantsStarted 2018-02-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: One year

Trial details

NCT IDNCT03173053

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-14

View on ClinicalTrials.gov More Staphylococcus Aureus trials