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Results interim-analysis
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| University College, London | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline | Drug | tablet |
| |
| Trimethoprim |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Developing long-term antimicrobial resistance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joost PH Drenth, MD, PhD | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Universitetshospital | Aalborg | 9000 | Denmark | |||
| Rigshospitalet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36965196 | Derived | 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. | |
| 29954418 |
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| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| D000090124 | Intestinal Failure |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D014295 | Trimethoprim |
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| D002981 | Clindamycin |
| D017291 | Clarithromycin |
| D002939 | Ciprofloxacin |
| D005672 | Fusidic Acid |
| D012293 | Rifampin |
| D002710 | Chlorhexidine |
| D016712 | Mupirocin |
| D011206 | Povidone-Iodine |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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Multicenter, randomized controlled, open label superiority trial
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| Drug |
tablet |
|
| Sulfamethoxazole/trimethoprim | Drug | tablet |
|
|
| Clindamycin | Drug | tablet |
|
| Clarithromycin | Drug | tablet |
|
| Ciprofloxacin | Drug | tablet |
|
| Fusidic Acid | Drug | tablet or ointment |
|
| Rifampin | Drug | tablet |
|
| Chlorhexidine | Drug | Mouthwash or bodywash |
|
| Mupirocin | Drug | Nasal ointment |
|
| Betadine | Drug | Shampoo |
|
Long-term antimicrobial resistance at 6 and 12 months (measured with standard cultures and NGS)
| 6 and 12 months |
| 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 |
| 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 |
| Number of catheter removals | Number of catheter removals based on data from electronic patient dossier | One year |
| Mortality | Mortality based on data from electronic patient dossier | One year |
| S. aureus transmission | S. aureus transmission routes from caregiver to patient (measured with NGS). | One year |
| Patient compliance | Patient compliance (measured with medication files, counting pills, trial-specific medication diary). | Every three months during one year |
| Adverse events | Adverse events (measured with (serious) adverse event forms every 3 months). | Every three months during one year |
| Predictors for infections and treatment outcome | Predictors for infections and treatment failure/success (binominal regression analysis). | One year |
| Health related quality of life | Generic health related quality of life (measured with a validated questionnaire (EQ5D-5L)). | 0, 6 and 12 months |
| Healthcare related costs. | Cost-effectiveness analysis | One year |
| Copenhagen |
| 2100 |
| Denmark |
| Radboud UMC | Nijmegen | Gelderland | 6500HB | Netherlands |
| AMC | Amsterdam | North Holland | 100DD | Netherlands |
| 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. |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002775 | Cholestadienols |
| D002774 | Cholestadienes |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D004852 | Epoxy Compounds |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D011714 | Pyrans |
| D005227 | Fatty Acids |
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |