CARRIER-trial: S. aureus decolonization in HPN patients
Research type
Research Study
Full title
Long-term Staphylococcus aureus decolonization in patients on home parenteral nutrition: a randomized multicenter trial.
IRAS ID
246324
Contact name
Farooq Rahman
Contact email
Sponsor organisation
Radboudumc
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
848015009, Projectcode Governmental Grant (ZonMw)
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
BACKGROUND:
Patients on home parenteral nutrition (HPN) are exposed to a life-long risk of developing severe infections with the skin bacteria S. aureus. The most feared infection is S. aureus bacteremia (SAB). SAB is the case when S. aureus enters the bloodstream through the catheter entrance. This poses a threat for both catheter and patient survival and may lead to a permanent loss of vascular access. S. aureus carriage decolonization (a treatment that targets on removing the bacteria from the body) has proven successful in the prevention of S. aureus infections and is a key strategy to maintain venous access and avoid hospitalization.
OBJECTIVE:
To identify the most effective and safe long-term S. aureus carriage decolonization strategy in patients on HPN. Ultimately this will lead to less antimicrobial resistance, less catheter removals and lower mortality rates. Also, other chronic patient groups, such as hemodialysis patients, may benefit from this trial as well.
STUDY DESIGN:
Randomized multicenter trial carried out in the Netherlands and United Kingdom.
POPULATION:
Adult HPN patients carrying the skin bacteria S. aureus .
INTERVENTION:
Patients will be allocated to:
1) a search and destroy (SD) strategy: a quick and short treatment with 2 antibiotics (pills or infusion) during one week.
or
2) a continuous suppression (CS) strategy: a monthly repeated short local antibiotic and antiseptic treatment (soap, mouthwash and nasal ointment).
OUTCOME MEASURES:
Primary outcome: percentage of patients decolonized for S. aureus during one year.
Secondary outcomes: antimicrobial resistance, side effects, patient adherence, incidence of (S. aureus) infections, catheter removals, mortality rates, S. aureus transmission routes, quality of life and costs.
TIME SCHEDULE
In a period of 2 years (Q3 2018-Q3 2020) patients will be screened for eligibility. Included patients will be followed-up during one year.REC name
London - Fulham Research Ethics Committee
REC reference
18/LO/1502
Date of REC Opinion
6 Nov 2018
REC opinion
Further Information Favourable Opinion