S. Aureus Decolonization in HPN Patients. (CARRIER)

Radboud University Medical Center

Status: Terminated

Conditions: Motility Disorder; Staphylococcus Aureus

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03173053

NL 61885.091.17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Search and destroy (SD) strategy

Active Comparator group

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

Treatment:

Drug: Betadine

Drug: Ciprofloxacin

Drug: Mupirocin

Drug: Rifampin

Drug: Fusidic Acid

Drug: Clarithromycin

Drug: Clindamycin

Drug: Sulfamethoxazole/trimethoprim

Drug: Trimethoprim

Drug: Doxycycline

Drug: Chlorhexidine

Continuous suppression (CS) strategy

Active Comparator group

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

Treatment:

Drug: Betadine

Drug: Mupirocin

Drug: Chlorhexidine