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S. Aureus Decolonization in HPN Patients. (CARRIER)

Primary Purpose

Staphylococcus Aureus, Motility Disorder

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Doxycycline
Trimethoprim
Sulfamethoxazole/trimethoprim
Clindamycin
Clarithromycin
Ciprofloxacin
Fusidic Acid
Rifampin
Chlorhexidine
Mupirocin
Betadine
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Staphylococcus Aureus focused on measuring S. aureus, Home Parenteral Nutrition, Intestinal failure, Eradication, Decolonization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aalborg Universitetshospital
  • Rigshospitalet
  • Radboud UMC
  • AMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Search and destroy (SD) strategy

Continuous suppression (CS) strategy

Arm Description

A quick and, short topical decolonization treatment combined with systemic antibiotics for S. aureus. Drug: Doxycycline 200mg once daily during one week Drug: Trimethoprim 200mg twice daily during one week Drug: Co-trimoxazol (Sulfamethoxazole/trimethoprim) 960mg twice daily during one week Drug: Clindamycin 600mg thrice daily during one week Drug: Clarithromycin 500mg twice daily during one week Drug: Ciprofloxacin 750mg twice daily during one week Drug: Fusidic acid (tablet) 500mg thrice daily during one week Drug: Rifampin 600mg twice daily during one week Drug: Mupirocin nasal ointment 20mg/g thrice daily during one week Drug: Fusidic acid ointment 20mg/g thrice daily during during five days Drug: Chlorhexidine body wash 40 mg/ml once daily during five days Drug: Betadine shampoo 75 mg/ml once daily during five days Drug: Chlorhexidine oropharyngeal rinse 2mg/ml thrice daily during five days

A repeated, continuous, topical decolonization treatment of S. aureus Drug: Mupirocin nasal ointment 20mg/g thrice daily during one week Drug: Fusidic acid ointment 20mg/g thrice daily during during five days Drug: Chlorhexidine body wash 40 mg/ml once daily during five days Drug: Betadine shampoo 75 mg/ml once daily during five days Drug: Chlorhexidine oropharyngeal rinse 2mg/ml thrice daily during five days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 29, 2017
Last Updated
May 25, 2022
Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT03173053
Brief Title
S. Aureus Decolonization in HPN Patients.
Acronym
CARRIER
Official Title
Long-term StaphyloCoccus Aureus decolonizAtion in Patients on Home parenteRal nutRition: a randomIzed multicEnter tRial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Results interim-analysis
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
October 14, 2021 (Actual)
Study Completion Date
October 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus, Motility Disorder
Keywords
S. aureus, Home Parenteral Nutrition, Intestinal failure, Eradication, Decolonization

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, randomized controlled, open label superiority trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Search and destroy (SD) strategy
Arm Type
Active Comparator
Arm Description
A quick and, short topical decolonization treatment combined with systemic antibiotics for S. aureus. Drug: Doxycycline 200mg once daily during one week Drug: Trimethoprim 200mg twice daily during one week Drug: Co-trimoxazol (Sulfamethoxazole/trimethoprim) 960mg twice daily during one week Drug: Clindamycin 600mg thrice daily during one week Drug: Clarithromycin 500mg twice daily during one week Drug: Ciprofloxacin 750mg twice daily during one week Drug: Fusidic acid (tablet) 500mg thrice daily during one week Drug: Rifampin 600mg twice daily during one week Drug: Mupirocin nasal ointment 20mg/g thrice daily during one week Drug: Fusidic acid ointment 20mg/g thrice daily during during five days Drug: Chlorhexidine body wash 40 mg/ml once daily during five days Drug: Betadine shampoo 75 mg/ml once daily during five days Drug: Chlorhexidine oropharyngeal rinse 2mg/ml thrice daily during five days
Arm Title
Continuous suppression (CS) strategy
Arm Type
Active Comparator
Arm Description
A repeated, continuous, topical decolonization treatment of S. aureus Drug: Mupirocin nasal ointment 20mg/g thrice daily during one week Drug: Fusidic acid ointment 20mg/g thrice daily during during five days Drug: Chlorhexidine body wash 40 mg/ml once daily during five days Drug: Betadine shampoo 75 mg/ml once daily during five days Drug: Chlorhexidine oropharyngeal rinse 2mg/ml thrice daily during five days
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Trimethoprim
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Sulfamethoxazole/trimethoprim
Other Intervention Name(s)
Bactrimel
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Clindamycin
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Fusidic Acid
Intervention Description
tablet or ointment
Intervention Type
Drug
Intervention Name(s)
Rifampin
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Intervention Description
Mouthwash or bodywash
Intervention Type
Drug
Intervention Name(s)
Mupirocin
Intervention Description
Nasal ointment
Intervention Type
Drug
Intervention Name(s)
Betadine
Intervention Description
Shampoo
Primary Outcome Measure Information:
Title
Proportion of patients totally eradicated for S. aureus during one year
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Proportion of patients totally eradicated after one year
Description
Proportion of patients totally eradicated for S. aureus based on negative cultures performed after one year
Time Frame
One year
Title
Developing long-term antimicrobial resistance
Description
Long-term antimicrobial resistance at 6 and 12 months (measured with standard cultures and NGS)
Time Frame
6 and 12 months
Title
Incidence of S. aureus infections
Description
Incidence of S. aureus infections measured with (serious) adverse events forms every 3 months
Time Frame
Every 3 months during one year
Title
Overall incidence of infections
Description
Overall incidence and time to onset of infections measured with (serious) adverse events forms every 3 months
Time Frame
Every three months during one year
Title
Number of catheter removals
Description
Number of catheter removals based on data from electronic patient dossier
Time Frame
One year
Title
Mortality
Description
Mortality based on data from electronic patient dossier
Time Frame
One year
Title
S. aureus transmission
Description
S. aureus transmission routes from caregiver to patient (measured with NGS).
Time Frame
One year
Title
Patient compliance
Description
Patient compliance (measured with medication files, counting pills, trial-specific medication diary).
Time Frame
Every three months during one year
Title
Adverse events
Description
Adverse events (measured with (serious) adverse event forms every 3 months).
Time Frame
Every three months during one year
Title
Predictors for infections and treatment outcome
Description
Predictors for infections and treatment failure/success (binominal regression analysis).
Time Frame
One year
Title
Health related quality of life
Description
Generic health related quality of life (measured with a validated questionnaire (EQ5D-5L)).
Time Frame
0, 6 and 12 months
Title
Healthcare related costs.
Description
Cost-effectiveness analysis
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joost PH Drenth, MD, PhD
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Aalborg Universitetshospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Radboud UMC
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500HB
Country
Netherlands
Facility Name
AMC
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
100DD
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29954418
Citation
Gompelman M, Wouters Y, Kievit W, Hopman J, Wertheim HF, Bleeker-Rovers CP, Wanten GJA. Long-term Staphylococcus aureus decolonization in patients on home parenteral nutrition: study protocol for a randomized multicenter trial. Trials. 2018 Jun 28;19(1):346. doi: 10.1186/s13063-018-2732-2.
Results Reference
derived

Learn more about this trial

S. Aureus Decolonization in HPN Patients.

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