S. Aureus Decolonization in HPN Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-08

Study Completion Date

2021-10-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Staphylococcus Aureus Bacteremia Antibiotic Treatment Options

NCT01792804

Staphylococcus Aureus Infection

COMPLETED PHASE3

Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants

NCT01827358

Staphylococcal Infection

COMPLETED PHASE2

Plasma Pharmacological Monitoring of M Penicillins in Methicillin-sensitive Staphylococcus Aureus Bacteremia

NCT06495697

Staphylococcus Aureus Infection

RECRUITING

Efficacy of a Short-term Sequential Therapy in Non-complicated Catheter Related Bacteremia by Methicillin- Susceptible S.Aureus.

NCT01875263

Staphylococcus

TERMINATED PHASE3

Antimicrobial Photodynamic Therapy in the Nasal Decolonization of Maintenance Hemodialysis Patients

NCT04047914

Photochemotherapy Renal Insufficiency, Chronic

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Staphylococcus Aureus Motility Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter, randomized controlled, open label superiority trial

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Doxycycline

Intervention Type DRUG

tablet

Trimethoprim

Intervention Type DRUG

tablet

Sulfamethoxazole/trimethoprim

Intervention Type DRUG

tablet

Clindamycin

Intervention Type DRUG

tablet

Clarithromycin

Intervention Type DRUG

tablet

Ciprofloxacin

Intervention Type DRUG

tablet

Fusidic Acid

Intervention Type DRUG

tablet or ointment

Rifampin

Intervention Type DRUG

tablet

Chlorhexidine

Intervention Type DRUG

Mouthwash or bodywash

Mupirocin

Intervention Type DRUG

Nasal ointment

Betadine

Intervention Type DRUG

Shampoo

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

Group Type ACTIVE_COMPARATOR

Chlorhexidine

Intervention Type DRUG

Mouthwash or bodywash

Mupirocin

Intervention Type DRUG

Nasal ointment

Betadine

Intervention Type DRUG

Shampoo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Doxycycline

tablet

Intervention Type DRUG

Trimethoprim

tablet

Intervention Type DRUG

Sulfamethoxazole/trimethoprim

tablet

Intervention Type DRUG

Clindamycin

tablet

Intervention Type DRUG

Clarithromycin

tablet

Intervention Type DRUG

Ciprofloxacin

tablet

Intervention Type DRUG

Fusidic Acid

tablet or ointment

Intervention Type DRUG

Rifampin

tablet

Intervention Type DRUG

Chlorhexidine

Mouthwash or bodywash

Intervention Type DRUG

Mupirocin

Nasal ointment

Intervention Type DRUG

Betadine

Shampoo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Bactrimel

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No