Skin and Subcutaneous Tissue Fungal InfectionsNCT02681458
Superficial and Cutaneous Fungal Infections Among Drug-users in Northeast Region of Iran
An observational study of Skin and Subcutaneous Tissue Fungal Infections, run by Islamic Azad University of Mashhad at 1 site in Iran.
Trial summary
The purpose of this study was about survey of prevalence of fungal infections among drug users referring to methadone wards of Hospitals in northeast region of Iran Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Skin and Subcutaneous Tissue Fungal Infections
- What is being tested?
- Direct Examination
- How many people
- 1,436 participants
- Where
- 1 siteIran
- Study dates
- Aug 2013to Apr 2014
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: people from northeast region of Iran referring to Methadone clinics. there were no limitations of age and sex.
Who may be able to join
- Suspected fungal lesions
Who cannot join
- non use of local or edible anti-fungal drugs and not taking bath within the last 48 hours of testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Dermatophytosis and Other Fungal Infections Between Drug Users and Non Drug Users
The purpose of this study was about survey of prevalence of fungal infections among drug users referring to methadone wards of Hospitals in northeast region of Iran
Read the detailed description
There were two groups with overall members of 1436. Statistically, the investigators have used "Likelihood ratio " and " Exact's Fisher" tests.
- Being tested
- Direct Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct ExaminationOther
It was an observational study and subjects received their routine treatment.
| Study group | Role | What they receive |
|---|---|---|
| Drug Users | Case group that consisted of drug users with fungal infections Receives: Other: Direct Examination | |
| Non-drug Users | Control group that consisted of non drug users with fungal infections Receives: Other: Direct Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Prevalence of Superficial and Cutaneous Fungal Infections Among Drug and Non-Drug Users
Measured: up to two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startAug 2013
- Primary completionMar 2014
- Study completionApr 2014
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 Skin and Subcutaneous Tissue Fungal InfectionsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,436 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University of Mashhad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Yazdanfar, Islamic Azad University of Mashhad
- Investigators
- Hassan Yazdanfar, MD, PhD, Study chair, assistant professor of mycology and parasitology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681458
- Sponsor's protocol ID
- IslamicAUM
- Status last verified
- Apr 2016
- First submitted
- 31 Jan 2016
- Last updated
- 20 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: The investigators have not decided about this issue yet
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Dermatophytosis and Other Fungal Infections Between Drug Users and Non Drug Users
- ClinicalTrials.gov ID
- NCT02681458
- Acronym / sponsor ID
- IslamicAUM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,436 participants (actual)
- Lead sponsor
- Islamic Azad University of MashhadUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Posted 20 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was about survey of prevalence of fungal infections among drug users referring to methadone wards of Hospitals in northeast region of Iran
Detailed description
There were two groups with overall members of 1436. Statistically, the investigators have used "Likelihood ratio " and " Exact's Fisher" tests.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Users | – | Other: Direct ExaminationCase group that consisted of drug users with fungal infections |
| Non-drug Users | – | Other: Direct ExaminationControl group that consisted of non drug users with fungal infections |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- people from northeast region of Iran referring to Methadone clinics. there were no limitations of age and sex.
Key inclusion criteria (1 listed)
- Suspected fungal lesions
Key exclusion criteria (1 listed)
- non use of local or edible anti-fungal drugs and not taking bath within the last 48 hours of testing
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 |
|---|---|---|
| Direct ExaminationIt was an observational study and subjects received their routine treatment. | Other | Drug Users, Non-drug Users |
Primary outcome
The Prevalence of Superficial and Cutaneous Fungal Infections Among Drug and Non-Drug Users
Time frame: up to two months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. The investigators have not decided about this issue yet
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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.
Hassan Yazdanfar, MD, PhD study chair
assistant professor of mycology and parasitology
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 Skin and Subcutaneous Tissue Fungal Infections, run by Islamic Azad University of Mashhad at 1 site in Iran.
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 20 May 2016. 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 Iran. 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 20 May 2016). 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?
The Prevalence of Superficial and Cutaneous Fungal Infections Among Drug and Non-Drug Users (time frame: up to two months). 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 20 May 2016.