Staphylococcus AureusCARRIERNCT03173053

S. Aureus Decolonization in HPN Patients.

A study testing Doxycycline, Trimethoprim and Sulfamethoxazole/trimethoprim in people with Staphylococcus Aureus and Motility Disorder, run by Radboud University Medical Center at 4 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Staphylococcus Aureus, Motility Disorder
What is being tested?: Doxycycline, Trimethoprim and Sulfamethoxazole/trimethoprim
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 4 sitesin 2 countries
Study dates: 8 Feb 2018to 14 Oct 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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 locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Denmark2 sites

Aalborg Universitetshospital
Aalborg, 9000
Rigshospitalet
Copenhagen, 2100

Other trials in Denmark

Netherlands2 sites

AMC
Amsterdam, North Holland, 100DD
Radboud UMC
Nijmegen, Gelderland, 6500HB

Other trials in Netherlands

About this study

Official title: Long-term StaphyloCoccus Aureus decolonizAtion in Patients on Home parenteRal nutRition: a randomIzed multicEnter tRial.

Read the 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.

Conditions: Staphylococcus Aureus, Motility Disorder
Being tested: Doxycycline, Trimethoprim, Sulfamethoxazole/trimethoprim, Clindamycin, Clarithromycin
Keywords: S. aureus, Home Parenteral Nutrition, Intestinal failure, Eradication, Decolonization
Medical subject headings: Staphylococcal Infections, Intestinal Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DoxycyclineDrug
tablet
TrimethoprimDrug
tablet
Sulfamethoxazole/trimethoprimDrug
Also called Bactrimel
tablet
ClindamycinDrug
tablet
ClarithromycinDrug
tablet
CiprofloxacinDrug
tablet
Fusidic AcidDrug
tablet or ointment
RifampinDrug
tablet
ChlorhexidineDrug
Mouthwash or bodywash
MupirocinDrug
Nasal ointment
BetadineDrug
Shampoo

Study groups in NCT03173053
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: Chlorhexidine; Drug: Mupirocin; Drug: Betadine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: One year

Secondary outcomes (12)

Proportion of patients totally eradicated after one year
Proportion of patients totally eradicated for S. aureus based on negative cultures performed after one year
Measured: One year
Developing long-term antimicrobial resistance
Long-term antimicrobial resistance at 6 and 12 months (measured with standard cultures and NGS)
Measured: 6 and 12 months
Incidence of S. aureus infections
Incidence of S. aureus infections measured with (serious) adverse events forms every 3 months
Measured: 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
Measured: Every three months during one year
Number of catheter removals
Number of catheter removals based on data from electronic patient dossier
Measured: One year
Mortality
Mortality based on data from electronic patient dossier
Measured: One year
S. aureus transmission
1. aureus transmission routes from caregiver to patient (measured with NGS).
Measured: One year
Patient compliance
Patient compliance (measured with medication files, counting pills, trial-specific medication diary).
Measured: Every three months during one year
Adverse events
Adverse events (measured with (serious) adverse event forms every 3 months).
Measured: Every three months during one year
Predictors for infections and treatment outcome
Predictors for infections and treatment failure/success (binominal regression analysis).
Measured: One year
Health related quality of life
Generic health related quality of life (measured with a validated questionnaire (EQ5D-5L)).
Measured: 0, 6 and 12 months
Healthcare related costs.
Cost-effectiveness analysis
Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 201814 Oct 2021

First posted1 Jun 2017
Study start8 Feb 2018
Primary completion14 Oct 2021
Study completion14 Oct 2021

Why it stopped: Results interim-analysis

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Multicenter, randomized controlled, open label superiority trial
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03173053
Sponsor's protocol ID: NL 61885.091.17
Acronym: CARRIER
Status last verified: Oct 2020
First submitted: 29 May 2017
Last updated: 31 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 36965196
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.
PubMed 29954418

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin Resistance in Staphylococcus Aureus (MRSA)
Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
HNSCC
RecruitingPhase 3
Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis
Infective Endocarditis
Active, not recruitingPhase 1
A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults
Staphylococcus Aureus Bloodstream Infection

All Staphylococcus Aureus trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term StaphyloCoccus Aureus decolonizAtion in Patients on Home parenteRal nutRition: a randomIzed multicEnter tRial.
ClinicalTrials.gov ID: NCT03173053
Acronym / sponsor ID: CARRIER / NL 61885.091.17
Conditions: Staphylococcus Aureus, Motility Disorder
Keywords: S. aureus, Home Parenteral Nutrition, Intestinal failure, Eradication, Decolonization
Study type: Interventional
Recruitment status: TerminatedReason stopped: Results interim-analysis
Enrolment: 63 participants (actual)
Lead sponsor: Radboud University Medical CenterUniversity, hospital or other
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University College, London
Study start: 8 Feb 2018 (actual)
Primary completion: 14 Oct 2021 (actual)
Study completion: 14 Oct 2021 (actual)
First posted: 1 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Multicenter, randomized controlled, open label superiority trial

Arm	Type	Receives
Search and destroy (SD) strategy	Active comparator	Drug: Doxycycline, Drug: Trimethoprim, Drug: Sulfamethoxazole/trimethoprim, Drug: Clindamycin, Drug: Clarithromycin, Drug: Ciprofloxacin, Drug: Fusidic Acid, Drug: Rifampin, Drug: Chlorhexidine, Drug: Mupirocin, Drug: BetadineA 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	Drug: Chlorhexidine, Drug: Mupirocin, Drug: BetadineA 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Doxycyclinetablet	Drug	Search and destroy (SD) strategy
Trimethoprimtablet	Drug	Search and destroy (SD) strategy
Sulfamethoxazole/trimethoprimAlso: Bactrimeltablet	Drug	Search and destroy (SD) strategy
Clindamycintablet	Drug	Search and destroy (SD) strategy
Clarithromycintablet	Drug	Search and destroy (SD) strategy
Ciprofloxacintablet	Drug	Search and destroy (SD) strategy
Fusidic Acidtablet or ointment	Drug	Search and destroy (SD) strategy
Rifampintablet	Drug	Search and destroy (SD) strategy
ChlorhexidineMouthwash or bodywash	Drug	Continuous suppression (CS) strategy, Search and destroy (SD) strategy
MupirocinNasal ointment	Drug	Continuous suppression (CS) strategy, Search and destroy (SD) strategy
BetadineShampoo	Drug	Continuous suppression (CS) strategy, Search and destroy (SD) strategy

Primary outcome

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.

12 secondary outcomes

Proportion of patients totally eradicated after one year
Time frame: One year
Developing long-term antimicrobial resistance
Time frame: 6 and 12 months
Incidence of S. aureus infections
Time frame: Every 3 months during one year
Overall incidence of infections
Time frame: Every three months during one year
Number of catheter removals
Time frame: One year
Mortality
Time frame: One year
S. aureus transmission
Time frame: One year
Patient compliance
Time frame: Every three months during one year
Adverse events
Time frame: Every three months during one year
Predictors for infections and treatment outcome
Time frame: One year
Health related quality of life
Time frame: 0, 6 and 12 months
Healthcare related costs.
Time frame: One year

Results and safety

The study was stopped early (reason given: Results interim-analysis). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
Derived from this study: PubMed 36965196Gompelman 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.
Derived from this study: PubMed 29954418Gompelman 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.
Individual participant dataSharing planned: No

Related trials for Staphylococcus Aureus

Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin Resistance in Staphylococcus Aureus (MRSA)
Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
HNSCC
RecruitingPhase 3
Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis
Infective Endocarditis
Active, not recruitingPhase 1
A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults
Staphylococcus Aureus Bloodstream Infection

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joost PH Drenth, MD, PhD study director

Sponsor GmbH

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Results interim-analysis). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients totally eradicated for S. aureus during one year (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03173053, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.