Nasal Antisepsis for C. Auris Prevention
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMary K Hayden
About this trial
This is a randomized, controlled, open-label trial of effect of 10% povidone iodine intranasal antisepsis on the detection of Candida auris.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
History of C. auris colonization or infection
Patient in a participating facility
Disqualifiers
History of severe allergy to iodine-based products, defined as anaphylaxis or rash
Currently breastfeeding or pregnant
Non-English language speaking
Trial design
Design model
Parallel
Treatments tested in this trial
Povidone Iodine Topical
DrugTopical intranasal povidone iodine (10%) twice daily for 5 days
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Intranasal Povidone IodineActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Detection of C. auris from the anterior nares
Culture detection of C. auris from anterior nares on intervention day 5.
Time frame
Through study completion and data analysis in three years (2028)Secondary outcomes
1
Detection of C. auris from body sites other than anterior nares
Culture detection of C. auris from body sites other than anterior nares. The investigators will compare detection of C. auris by culture during intervention vs post-intervention periods.
Time frame
Through study completion and data analysis in three years (2028)2
Detection of C. auris from environmental surfaces
Culture detection of C. auris from participant environmental room surfaces. The investigators will compare detection of C. auris by culture during intervention vs post-intervention periods.
Time frame
Through study completion and data analysis in three years (2028)3
Detection of methicillin-resistant Staphylococcus aureus (MRSA) from body sites other than anterior nares
Culture detection of MRSA from body sites other than anterior nares. The investigators will compare detection of MRSA by culture during intervention vs post-intervention periods.
Time frame
Through study completion and data analysis in three years (2028)4
Detection of MRSA from environmental surfaces
Culture detection of MRSA from participant environmental room surfaces. The investigators will compare detection of MRSA by culture during intervention vs post-intervention periods.
Time frame
Through study completion and data analysis in three years (2028)Other outcomes
1
Non-susceptibility of C. auris to povidone iodine
To assess for development of non-susceptibility of C. auris to povidone iodine, we will evaluate for a ≥4-fold increase in minimal inhibitory concentration (MIC) of povidone iodine pre- and post-intervention
Time frame
Through study completion and data analysis in three years (2028)2
Change in microbiome community
To assess for microbiome changes during the intervention, anterior nares samples will be analyzed using amplicon and/or metagenomic sequencing approaches. The investigators will compare the microbial community during intervention vs post-intervention periods.
Time frame
Through study completion and data analysis in three years (2028)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mary K Hayden
Lead sponsor
Rush University Medical Center
Sponsor institution
Rush University Medical Center
Collaborator
RML Specialty Hospital
Collaborator
Source ClinicalTrials.gov