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Incidence of Oral Candidiasis, Prevalence of C. Dubliniensis in HIV Patients and In-vitro Azole Susceptibility (ICONIC)
This study has been terminated.
(Dr. Vindas completed his fellowship + low enrollment)
Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00692783
First received: May 28, 2008
Last updated: May 7, 2015
Last verified: May 2015
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Purpose
C. dubliniensis has been identified as pathogen in Oropharyngeal Candidiasis(OPC)particularly among HIV patients. Azole therapy is a cornerstone in OPC, but resistance within C. dubliniensis isolates to diflucan is common.This is a prospective collection of biological specimens from oropharyngeal cavity with the purpose of determining the prevalence of C. dubliniensis in HIV/AIDS patients at the Duval County Department of Health Comprehensive care Center. It is hereto proposed an estimation of azole-resistance in these isolates.
| Condition |
|---|
| Candidiasis HIV Infections |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Incidence of Oral Candidiasis, Prevalence of Candida Dubliniensis in HIV Patients and In-vitro Azole Susceptibility. (I.C.O.N.I.C.) |
Resource links provided by NLM:
Further study details as provided by University of Florida:
Primary Outcome Measures:
- Incidence of oropharyngeal candidiasis in our HIV population; estimation of the prevalence of candida dubliniensis and pattern of azole resistance to direct future treatment [ Time Frame: April 2009 ]
| Enrollment: | 10 |
| Study Start Date: | May 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
This is a study to try to establish the prevalence of C. dubliniensis as a causative organism of OPC in HIV and/or AIDS patients. We will aim to establish the resistance pattern for azoles but also for Flucytosine and amphotericin of these isolates.
This study will serve as a support to previously published articles that have suggested intrinsic azole-resistance within this particular species of candida and we will try to postulate its possible correlation with clinical failure.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV with or without AIDS defining illnesses at the Boulevard Comprehensive Care Center
Criteria
Inclusion Criteria:
- Any patient 18 years old or older with a documented diagnosis of HIV infection with or without AIDS-defining illnesses at the time of assessment, who is presenting with clinical symptoms and physical findings compatible with oropharyngeal candidiasis (as defined by the IDSA Guidelines for the Treatment and Management of HIV and HIV- related complications.
Exclusion Criteria:
- Any prior diagnosis or established treatment for oropharyngeal, mucocutaneous or esophageal candidiasis documented in the patient's chart or any proven diagnosis based on reviews of physically available medical records and or history provided by patients that can be subject to later confirmation pertaining to the use of parenteral antifungals within 6 months prior to enrollment (azoles, echinocandins, amphotericin B, Flucytosine, etc).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00692783
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692783
Locations
| United States, Florida | |
| Duval County Department of Health. Boulevard Comprehensive Care Center | |
| Jacksonville, Florida, United States, 32206 | |
Sponsors and Collaborators
University of Florida
Investigators
| Principal Investigator: | Jose Vindas, MD | University of Florida |
More Information
Publications:
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT00692783 History of Changes |
| Other Study ID Numbers: |
UFJ2008-19 |
| Study First Received: | May 28, 2008 |
| Last Updated: | May 7, 2015 |
Keywords provided by University of Florida:
|
candida dubliniensis candidiasis |
HIV AIDS azole resistance. |
Additional relevant MeSH terms:
|
HIV Infections Candidiasis Disease Susceptibility Candidiasis, Oral Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Mycoses Disease Attributes Pathologic Processes Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on July 21, 2017