S. Aureus Decolonization in HPN Patients.

Staphylococcus Aureus Clinical Trial

— CARRIER  

Official title:

Long-term StaphyloCoccus Aureus decolonizAtion in Patients on Home parenteRal nutRition: a randomIzed multicEnter tRial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03173053
• Other study ID #: NL 61885.091.17
• Status: Terminated
• Phase: N/A
• Start date: February 8, 2018
• Est. completion date: October 14, 2021

Study information

• Verified date: October 2020
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: October 14, 2021
• Est. primary completion date: October 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Motility Disorder
• Staphylococcal Infections
• Staphylococcus Aureus

Intervention

Drug:
• Doxycycline
tablet
• Trimethoprim
tablet
• Sulfamethoxazole/trimethoprim
tablet
• Clindamycin
tablet
• Clarithromycin
tablet
• Ciprofloxacin
tablet
• Fusidic Acid
tablet or ointment
• Rifampin
tablet
• Chlorhexidine
Mouthwash or bodywash
• Mupirocin
Nasal ointment
• Betadine
Shampoo

Locations

Country	Name	City	State
Denmark	Aalborg Universitetshospital	Aalborg
Denmark	Rigshospitalet	Copenhagen
Netherlands	AMC	Amsterdam	Noord-Holland
Netherlands	Radboud UMC	Nijmegen	Gelderland

Sponsors (4)

Lead Sponsor	Collaborator
Radboud University Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University College, London, ZonMw: The Netherlands Organisation for Health Research and Development

Countries where clinical trial is conducted

Denmark,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients totally eradicated for S. aureus during 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.	One year
Secondary	Proportion of patients totally eradicated after one year	Proportion of patients totally eradicated for S. aureus based on negative cultures performed after one year	One year
Secondary	Developing long-term antimicrobial resistance	Long-term antimicrobial resistance at 6 and 12 months (measured with standard cultures and NGS)	6 and 12 months
Secondary	Incidence of S. aureus infections	Incidence of S. aureus infections measured with (serious) adverse events forms every 3 months	Every 3 months during one year
Secondary	Overall incidence of infections	Overall incidence and time to onset of infections measured with (serious) adverse events forms every 3 months	Every three months during one year
Secondary	Number of catheter removals	Number of catheter removals based on data from electronic patient dossier	One year
Secondary	Mortality	Mortality based on data from electronic patient dossier	One year
Secondary	S. aureus transmission	S. aureus transmission routes from caregiver to patient (measured with NGS).	One year
Secondary	Patient compliance	Patient compliance (measured with medication files, counting pills, trial-specific medication diary).	Every three months during one year
Secondary	Adverse events	Adverse events (measured with (serious) adverse event forms every 3 months).	Every three months during one year
Secondary	Predictors for infections and treatment outcome	Predictors for infections and treatment failure/success (binominal regression analysis).	One year
Secondary	Health related quality of life	Generic health related quality of life (measured with a validated questionnaire (EQ5D-5L)).	0, 6 and 12 months
Secondary	Healthcare related costs.	Cost-effectiveness analysis	One year