NCT00692783

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

5 months

First QC Date

May 28, 2008

Last Update Submit

May 7, 2015

Conditions

CandidiasisHIV Infections

Keywords

candidadubliniensiscandidiasisHIVAIDSazole resistance.

Outcome Measures

Primary Outcomes (1)

  • Incidence of oropharyngeal candidiasis in our HIV population; estimation of the prevalence of candida dubliniensis and pattern of azole resistance to direct future treatment

    April 2009

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV with or without AIDS defining illnesses at the Boulevard Comprehensive Care Center

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duval County Department of Health. Boulevard Comprehensive Care Center

Jacksonville, Florida, 32206, United States

Location

Related Publications (6)

  • 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.

    PMID: 9466736RESULT

  • 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.

    PMID: 11687311RESULT

  • 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.

    PMID: 7551019RESULT

  • 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.

    PMID: 18473572RESULT

  • 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.

    PMID: 10747150RESULT

  • 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.

    PMID: 10782340RESULT

MeSH Terms

Conditions

CandidiasisHIV InfectionsTorulopsisAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Jose Vindas, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2008

First Posted

June 6, 2008

Study Start

May 1, 2008

Primary Completion

October 1, 2008

Study Completion

January 1, 2009

Last Updated

May 8, 2015

Record last verified: 2015-05

Locations

US(1)