S. Aureus Decolonization in HPN Patients.

NCT03173053 | Terminated

• 1 other identifier: NL 61885.091.17
• Study Type: interventional
• Target: 63
• Locations: 2 countries
• Sites: 4

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.

Conditions

Staphylococcus Aureus; Motility Disorder

Keywords

S. aureus; Home Parenteral Nutrition; Intestinal failure; Eradication; Decolonization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Proportion of patients totally eradicated after one year

  One year

• Developing long-term antimicrobial resistance

  6 and 12 months

• Incidence of S. aureus infections

  Every 3 months during one year

• Overall incidence of infections

  Every three months during one year

• Number of catheter removals

  One year

Study Arms (2)

Search and destroy (SD) strategy

ACTIVE COMPARATOR

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; Drug: Trimethoprim; Drug: Sulfamethoxazole/trimethoprim; Drug: Clindamycin; Drug: Clarithromycin; Drug: Ciprofloxacin; Drug: Fusidic Acid; Drug: Rifampin; Drug: Chlorhexidine; Drug: Mupirocin; Drug: Betadine

Continuous suppression (CS) strategy

ACTIVE COMPARATOR

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; Drug: Mupirocin; Drug: Betadine

Interventions

Doxycycline DRUG

tablet

Search and destroy (SD) strategy

Trimethoprim DRUG

tablet

Search and destroy (SD) strategy

Sulfamethoxazole/trimethoprim DRUG

tablet

Also known as: Bactrimel

Search and destroy (SD) strategy

Clindamycin DRUG

tablet

Search and destroy (SD) strategy

Clarithromycin DRUG

tablet

Search and destroy (SD) strategy

Ciprofloxacin DRUG

tablet

Search and destroy (SD) strategy

Fusidic Acid DRUG

tablet or ointment

Search and destroy (SD) strategy

Rifampin DRUG

tablet

Search and destroy (SD) strategy

Chlorhexidine DRUG

Mouthwash or bodywash

Continuous suppression (CS) strategy; Search and destroy (SD) strategy

Mupirocin DRUG

Nasal ointment

Continuous suppression (CS) strategy; Search and destroy (SD) strategy

Betadine DRUG

Shampoo

Continuous suppression (CS) strategy; Search and destroy (SD) strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Aalborg Universitetshospital

Aalborg, 9000, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Radboud UMC

Nijmegen, Gelderland, 6500HB, Netherlands

Location

AMC

Amsterdam, North Holland, 100DD, Netherlands

Location

Related Publications (2)

• Gompelman M, Wezendonk GTJ, Wouters Y, Beurskens-Meijerink J, Fragkos KC, Rahman FZ, Coolen JPM, van Weerdenburg IJM, Wertheim HFL, Kievit W, Akkermans RP, Serlie MJ, Bleeker-Rovers CP, Wanten GJA. Randomized clinical trial: Long-term Staphylococcus aureus decolonization in patients on home parenteral nutrition. Clin Nutr. 2023 May;42(5):706-716. doi: 10.1016/j.clnu.2023.03.010. Epub 2023 Mar 17.

  PMID: 36965196 DERIVED

• 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.

  PMID: 29954418 DERIVED

MeSH Terms

Conditions

Staphylococcal Infections; Intestinal Failure

Interventions

Doxycycline; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination; Clindamycin; Clarithromycin; Ciprofloxacin; Fusidic Acid; Rifampin; Chlorhexidine; Mupirocin; Povidone-Iodine

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Sulfones; Sulfur Compounds; Drug Combinations; Pharmaceutical Preparations; Lincomycin; Lincosamides; Pyrrolidines; Glycosides; Carbohydrates; Erythromycin; Macrolides; Polyketides; Lactones; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cholestadienols; Cholestadienes; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Sterols; Membrane Lipids; Lipids; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Biguanides; Guanidines; Amidines; Epoxy Compounds; Ethers, Cyclic; Ethers; Pyrans; Fatty Acids; Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Povidone; Pyrrolidinones; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Joost PH Drenth, MD, PhD

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized controlled, open label superiority trial

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 1, 2017
• Study Start: February 8, 2018
• Primary Completion: October 14, 2021
• Study Completion: October 14, 2021
• Last Updated: May 31, 2022

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2); NL (2)