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:

Information provided by (Responsible Party):

University of Florida

ClinicalTrials.gov Identifier:

NCT00692783

First received: May 28, 2008

Last updated: September 16, 2011

Last verified: February 2009

History of Changes

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:

MedlinePlus related topics: HIV/AIDS Yeast Infections

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]


Estimated Enrollment:	100
Study Start Date:	May 2008
Study Completion Date:	January 2009
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Detailed Description:

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
Genders Eligible for Study:	Both
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).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Sullivan D, Coleman D. Candida dubliniensis: characteristics and identification. J Clin Microbiol. 1998 Feb;36(2):329-34. Review.

Milan EP, de Laet Sant' Ana P, de Azevedo Melo AS, Sullivan DJ, Coleman DC, Lewi D, Colombo AL. Multicenter prospective surveillance of oral Candida dubliniensis among adult Brazilian human immunodeficiency virus-positive and AIDS patients. Diagn Microbiol Infect Dis. 2001 Sep-Oct;41(1-2):29-35.

Sullivan DJ, Westerneng TJ, Haynes KA, Bennett DE, Coleman DC. Candida dubliniensis sp. nov.: phenotypic and molecular characterization of a novel species associated with oral candidosis in HIV-infected individuals. Microbiology. 1995 Jul;141 ( Pt 7):1507-21.

Sullivan DJ, Moran G, Donnelly S, Gee S, Pinjon E, McCartan B, Shanley DB, Coleman DC. Candida dubliniensis: An update. Rev Iberoam Micol. 1999 Jun;16(2):72-6.

Tintelnot K, Haase G, Seibold M, Bergmann F, Staemmler M, Franz T, Naumann D. Evaluation of phenotypic markers for selection and identification of Candida dubliniensis. J Clin Microbiol. 2000 Apr;38(4):1599-608.

Schorling SR, Kortinga HC, Froschb M, Mühlschlegel FA. The role of Candida dubliniensis in oral candidiasis in human immunodeficiency virus-infected individuals. Crit Rev Microbiol. 2000;26(1):59-68. Review.


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:	September 16, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:


candida dubliniensis candidiasis	HIV AIDS azole resistance.

Additional relevant MeSH terms:


Candidiasis Mycoses

ClinicalTrials.gov processed this record on March 03, 2015

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