To identify the most effective and safe long-term S. aureus carriage decolonization strategy in HPN patients. Ultimately this willlead to less antimicrobial resistance, less catheter removals and lower mortality rates. Also, other chronic…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: proportion of patients eradicated for S. aureus (nose, throat,
rectum, exit-site catheter) during one year.
Secondary outcome
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.
Background summary
Patients on home parenteral nutrition (HPN) are exposed to a life-long 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 objective
To identify the most effective and safe long-term S. aureus carriage
decolonization strategy in HPN patients. Ultimately this will
lead to less antimicrobial resistance, less catheter removals and lower
mortality rates. Also, other chronic patientgroups may
benefit from this trial as well, such as hemodialysis patients.
Study design
Randomized open-label multicenter trial in the Netherlands and Denmark.
Intervention
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 wash
and systemic antibiotics) or a continuous
suppression (CS) strategy: a repeated chronic topical treatment (nasal
mupirocin ointment, oropharyngeal chlorhexidine rinse
and chlorhexidine body wash).
Study burden and risks
Burden
The burden will consist of every 6 monthly visits, as is the standard follow-up
for HPN patients according to international HPN guidelines. Additionally, we
will perform tests and obtain data (e.g. adverse events) after 3 and 9 months
by the telephone. In case of unsuccessful eradication in the SD-strategy group
an additional phone call (20 minuts) and performing extra culture swabs will be
necessary. The expectation based on earlier experience is that it is a feasible
treatment protocol and it has little impact on daily life.
Risks:
There are no additional risks in this study, since usual care is being followed
in both strategies. The main 'known' risks associated with this study are the
known side effects, allergies and/or toxicity of the various prescribed
antibiotic drugs. It is currently uncertain which of the treatment strategies
mentioned above is most effective and safe.
Benefit and group relatedness
HPN patients, and likely other chronic patient groups such as hemodialysis
patients, will benefit from an evidence based effective long-term
decolonization protocol. Ultimately such protocol will lower S. aureus
infections and reduce subsequently hospitalizations, catheter removals,
mortality, antimicrobial resistance and costs. Furthermore, this study provides
guidance for further policy development and implementation of (longterm) S.
aureus decolonization protocols and other novel infection/transmission
preventive strategies.
Geert-Grooteplein-Zuid 8
Nijmegen 6500 HB
NL
Geert-Grooteplein-Zuid 8
Nijmegen 6500 HB
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03173053 |
| CCMO | NL61885.091.17 |