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

Sponsored by:	University of Florida
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00692783

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

MedlinePlus related topics: AIDS Yeast Infections

U.S. FDA Resources

Study Type:	Observational
Study Design:	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.)

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2008

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

Contacts

Contact: Katherine Rogers, BSN	904-253-1261	katherine_rogers@doh.state.fl.us
Contact: Jose Vindas, MD	904-253-1369	jose_vindas-cordero@doh.state.fl.us

Locations

United States, Florida
Duval County Department of Health. Boulevard Comprehensive Care Center	Recruiting
Jacksonville, Florida, United States, 32206
Contact: Katherine Rogers, BSN 904-253-1261 katherine_rogers@doh.state.fl.us
Contact: Jose Vindas, MD 904-253-1369 jose_vindas-cordero@doh.state.fl.us
Principal Investigator: Jose Vindas, MD
Sub-Investigator: Levonne Mitchell-Samon, MD

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator:

Jose Vindas, MD

University of Florida

More Information

Publications of Results:

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 ( Jose Pablo Vindas-Cordero; principal investigator )
Study ID Numbers:	UFJ2008-19
Study First Received:	May 28, 2008
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00692783
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

candida
dubliniensis
candidiasis

HIV
AIDS
azole resistance.

Study placed in the following topic categories:

Mouth Diseases
Candidiasis, Oral
Sexually Transmitted Diseases, Viral
Candidiasis
Disease Susceptibility
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Virus Diseases

Mycoses
HIV Infections
Sexually Transmitted Diseases
Stomatognathic Diseases
Genetic Predisposition to Disease
Torulopsis
Retroviridae Infections

Additional relevant MeSH terms:

Disease Attributes
RNA Virus Infections
Pathologic Processes
Slow Virus Diseases

Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009