Incidence of Oral Candidiasis, Prevalence of C. Dubliniensis in HIV Patients and In-vitro Azole Susceptibility - Full Text View

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:

Genetics Home Reference related topics: complement factor I deficiency

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

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. No abstract available.

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. No abstract available.

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:

HIV Infections
Acquired Immunodeficiency Syndrome
Candidiasis
Candidiasis, Oral
Disease Susceptibility
Genetic Predisposition to Disease
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycoses
Mouth Diseases
Stomatognathic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013

Incidence of Oral Candidiasis, Prevalence of C. Dubliniensis in HIV Patients and In-vitro Azole Susceptibility (ICONIC)