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

NCT ID: NCT00692783

Last Updated: 2015-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Candidiasis HIV Infections

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose Vindas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Duval County Department of Health. Boulevard Comprehensive Care Center

Jacksonville, Florida, United States

Site Status

Countries

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United States

References

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Sullivan D, Coleman D. Candida dubliniensis: characteristics and identification. J Clin Microbiol. 1998 Feb;36(2):329-34. doi: 10.1128/JCM.36.2.329-334.1998. No abstract available.

Reference Type RESULT
PMID: 9466736 (View on PubMed)

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. doi: 10.1016/s0732-8893(01)00290-5.

Reference Type RESULT
PMID: 11687311 (View on PubMed)

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 (Reading). 1995 Jul;141 ( Pt 7):1507-21. doi: 10.1099/13500872-141-7-1507.

Reference Type RESULT
PMID: 7551019 (View on PubMed)

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.

Reference Type RESULT
PMID: 18473572 (View on PubMed)

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. doi: 10.1128/JCM.38.4.1599-1608.2000.

Reference Type RESULT
PMID: 10747150 (View on PubMed)

Schorling SR, Kortinga HC, Froschb M, Muhlschlegel FA. The role of Candida dubliniensis in oral candidiasis in human immunodeficiency virus-infected individuals. Crit Rev Microbiol. 2000;26(1):59-68. doi: 10.1080/10408410091154183.

Reference Type RESULT
PMID: 10782340 (View on PubMed)

Other Identifiers

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UFJ2008-19

Identifier Type: -

Identifier Source: org_study_id

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