OnychomycosisNCT00233493
Spread of Dermatophytes Among Families
An observational study of Onychomycosis and Tinea Pedis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The objective is to demonstrate person-to-person spread of dermatophytes of the skin and nails among family members, as measured by fungal culture and DNA typing of the dermatophytes isolated. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Onychomycosis, Tinea Pedis
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to May 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study Design-Households with at least 2 residents and 1 individual (index person [IP]) with tinea pedis and/or onychomycosis were identified by screening. Infection was confirmed clinically and mycologically (potassium hydroxide [KOH] and culture positive) in the IP; then other members within the same household were examined for tinea pedis and/or onychomycosis using the same criteria. All participants with confirmed fungal infections were referred to their primary care physicians for appropriate treatment.
Who may be able to join
- -
Who cannot join
- use of antifungal agents, either oral or topical
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Demonstration of the Spread of Dermatophytes Through Casual Contact Among Family Household Members
The objective is to demonstrate person-to-person spread of dermatophytes of the skin and nails among family members, as measured by fungal culture and DNA typing of the dermatophytes isolated.
Read the detailed description
Enrolled families consist of at least two members over the age of 14. Once the index person is examined and a dermatophyte is isolated from either toenail or foot scale, other family members are examined and cultured. All dermatophyte isolates obtained from each family unit are compared using DNA typing and restriction length polymorphism (RFLP) to determine whether family members share the same organism or were infected by an outside source.
- Conditions
- Onychomycosis, Tinea Pedis
- Keywords
- dermatophytes
- Medical subject headings
- Onychomycosis, Tinea Pedis
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatophyte Species Distribution
To identify dermatophytes isolates known to cause onychomycosis and/or tinea pedis by Polymerase Chain Reaction (PCR)
Measured: Baseline
Secondary outcomes (3)
Dermatophyte Strain Types Among All Enrolled Households
Using southern blot analysis and RFLP to evaluate the isolates and strain types obtained from all enrolled households
Measured: Baseline
Number of Households With Dermatophyte Infection Spread
To determine if dermatophyte infection in household members could spread to other members, we analyzed the Southern blot and RFLP band patterns for different clinical isolates obtained from members residing in the same MIM households.
Measured: Baseline
Number of Participants Affected by the Association of Spread of Infection and History of Tinea Pedis or Onychomycosis
The relationship between spread of infection and whether a subject previously had onychomycosis, tinea pedis, or onychomycosis plus tinea pedis was investigated. We collected how many subjects had spread of infection and onychomycosis alone, or spread of infection and tinea pedis alone, as well as how many subjects had spread of infection and onychomycosis plus tinea pedis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study startMar 2005
- Primary completionJan 2009
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Mahmoud A Ghannoum, PhD, Principal investigator, Center for Medical Mycology, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233493
- Sponsor's protocol ID
- CSFO327KUS16
- Status last verified
- Aug 2024
- First submitted
- 3 Oct 2005
- Last updated
- 1 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of the Spread of Dermatophytes Through Casual Contact Among Family Household Members
- ClinicalTrials.gov ID
- NCT00233493
- Acronym / sponsor ID
- CSFO327KUS16
- Conditions
- Onychomycosis, Tinea Pedis
- Keywords
- dermatophytes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Mar 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Oct 2005 (estimated)
- Results
- Posted 1 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to demonstrate person-to-person spread of dermatophytes of the skin and nails among family members, as measured by fungal culture and DNA typing of the dermatophytes isolated.
Detailed description
Enrolled families consist of at least two members over the age of 14. Once the index person is examined and a dermatophyte is isolated from either toenail or foot scale, other family members are examined and cultured. All dermatophyte isolates obtained from each family unit are compared using DNA typing and restriction length polymorphism (RFLP) to determine whether family members share the same organism or were infected by an outside source.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study Design-Households with at least 2 residents and 1 individual (index person [IP]) with tinea pedis and/or onychomycosis were identified by screening. Infection was confirmed clinically and mycologically (potassium hydroxide [KOH] and culture positive) in the IP; then other members within the same household were examined for tinea pedis and/or onychomycosis using the same criteria. All participants with confirmed fungal infections were referred to their primary care physicians for appropriate treatment.
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- use of antifungal agents, either oral or topical
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dermatophyte Species Distribution
Time frame: Baseline
To identify dermatophytes isolates known to cause onychomycosis and/or tinea pedis by Polymerase Chain Reaction (PCR)
3 secondary outcomes
Dermatophyte Strain Types Among All Enrolled Households
Time frame: Baseline
Number of Households With Dermatophyte Infection Spread
Time frame: Baseline
Number of Participants Affected by the Association of Spread of Infection and History of Tinea Pedis or Onychomycosis
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mahmoud A Ghannoum, PhD principal investigator
Center for Medical Mycology, University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Onychomycosis and Tinea Pedis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 1 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dermatophyte Species Distribution (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2024.