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S. Aureus Decolonization in HPN Patients. (CARRIER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03173053
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : November 9, 2018
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Aalborg University Hospital
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Radboud University

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.

Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Motility Disorder Drug: Doxycycline Drug: Trimethoprim Drug: Sulfamethoxazole/trimethoprim Drug: Clindamycin Drug: Clarithromycin Drug: Ciprofloxacin Drug: Fusidic Acid Drug: Rifampin Drug: Chlorhexidine Drug: Mupirocin Drug: Betadine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, randomized controlled, open label superiority trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Long-term StaphyloCoccus Aureus decolonizAtion in Patients on Home parenteRal nutRition: a randomIzed multicEnter tRial.
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : February 8, 2021
Estimated Study Completion Date : August 8, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Search and destroy (SD) strategy

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

Drug: Doxycycline
tablet

Drug: Trimethoprim
tablet

Drug: Sulfamethoxazole/trimethoprim
tablet
Other Name: Bactrimel

Drug: Clindamycin
tablet

Drug: Clarithromycin
tablet

Drug: Ciprofloxacin
tablet

Drug: Fusidic Acid
tablet or ointment

Drug: Rifampin
tablet

Drug: Chlorhexidine
Mouthwash or bodywash

Drug: Mupirocin
Nasal ointment

Drug: Betadine
Shampoo

Active Comparator: Continuous suppression (CS) strategy

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

Drug: Chlorhexidine
Mouthwash or bodywash

Drug: Mupirocin
Nasal ointment

Drug: Betadine
Shampoo




Primary Outcome Measures :
  1. Proportion of patients totally eradicated for S. aureus during one year [ Time Frame: 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 :
  1. Proportion of patients totally eradicated after one year [ Time Frame: One year ]
    Proportion of patients totally eradicated for S. aureus based on negative cultures performed after one year

  2. Developing long-term antimicrobial resistance [ Time Frame: 6 and 12 months ]
    Long-term antimicrobial resistance at 6 and 12 months (measured with standard cultures and NGS)

  3. Incidence of S. aureus infections [ Time Frame: Every 3 months during one year ]
    Incidence of S. aureus infections measured with (serious) adverse events forms every 3 months

  4. Overall incidence of infections [ Time Frame: Every three months during one year ]
    Overall incidence and time to onset of infections measured with (serious) adverse events forms every 3 months

  5. Number of catheter removals [ Time Frame: One year ]
    Number of catheter removals based on data from electronic patient dossier

  6. Mortality [ Time Frame: One year ]
    Mortality based on data from electronic patient dossier

  7. S. aureus transmission [ Time Frame: One year ]
    S. aureus transmission routes from caregiver to patient (measured with NGS).

  8. Patient compliance [ Time Frame: Every three months during one year ]
    Patient compliance (measured with medication files, counting pills, trial-specific medication diary).

  9. Adverse events [ Time Frame: Every three months during one year ]
    Adverse events (measured with (serious) adverse event forms every 3 months).

  10. Predictors for infections and treatment outcome [ Time Frame: One year ]
    Predictors for infections and treatment failure/success (binominal regression analysis).

  11. Health related quality of life [ Time Frame: 0, 6 and 12 months ]
    Generic health related quality of life (measured with a validated questionnaire (EQ5D-5L)).

  12. Healthcare related costs. [ Time Frame: One year ]
    Cost-effectiveness analysis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173053


Contacts
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Contact: Michelle Gompelman, MD 0031611847365 ext 0031653523983 michelle.gompelman@radboudumc.nl
Contact: Geert JA Wanten, MD, PhD 0031243614760 geert.wanten@radboudumc.nl

Locations
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Denmark
Aalborg Universitetshospital Not yet recruiting
Aalborg, Denmark, 9000
Principal Investigator: Henrik Rasmussen, MD, PhD         
Rigshospitalet Not yet recruiting
Copenhagen, Denmark, 2100
Principal Investigator: Palle B Jeppesen, MD, PhD         
Netherlands
Radboud UMC Recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Principal Investigator: Michelle Gompelman, MD         
AMC Not yet recruiting
Amsterdam, Noord-Holland, Netherlands, 100DD
Principal Investigator: M J Serlie, MD, PhD         
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Aalborg University Hospital
Rigshospitalet, Denmark
Investigators
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Study Director: Joost PH Drenth, MD, PhD Sponsor GmbH
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03173053    
Other Study ID Numbers: NL 61885.091.17
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
S. aureus
Home Parenteral Nutrition
Intestinal failure
Eradication
Decolonization
Additional relevant MeSH terms:
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Chlorhexidine
Povidone-Iodine
Clarithromycin
Doxycycline
Ciprofloxacin
Rifampin
Clindamycin
Trimethoprim
Sulfamethoxazole
Mupirocin
Fusidic Acid
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents