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Anti-infective
Nasal Antiseptic for Fungal Infections
Phase 4
Recruiting
Led By Mary K. Hayden, MD
Research Sponsored by Mary K Hayden
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of C. auris colonization or infection
Be older than 18 years old
Must not have
Non-English language speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion and data analysis in three years (2028)
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will test whether using a specific type of antiseptic in the nose can help in detecting a type of fungus called Candida auris.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a C. auris infection or been colonized by it.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not speak English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion and data analysis in three years (2028)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion and data analysis in three years (2028)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Detection of C. auris from the anterior nares
Secondary study objectives
Detection of C. auris from body sites other than anterior nares
Detection of C. auris from environmental surfaces
Detection of MRSA from environmental surfaces
+1 moreOther study objectives
Change in microbiome community
Non-susceptibility of C. auris to povidone iodine
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Routine care.
Group II: Intranasal Povidone IodineActive Control1 Intervention
Nasal iodophor applied twice daily for five days.
Find a Location
Who is running the clinical trial?
Mary K HaydenLead Sponsor
Rush University Medical CenterOTHER
439 Previous Clinical Trials
250,126 Total Patients Enrolled
RML Specialty HospitalOTHER
5 Previous Clinical Trials
1,603 Total Patients Enrolled
Mary K. Hayden, MDPrincipal InvestigatorRush University Medical Center