Incidence of Oral Candidiasis, Prevalence of C. Dubliniensis in HIV Patients and In-vitro Azole Susceptibility (ICONIC)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 28, 2008 | ||||
| Last Updated Date | September 16, 2011 | ||||
| Start Date ICMJE | May 2008 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00692783 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Incidence of Oral Candidiasis, Prevalence of C. Dubliniensis in HIV Patients and In-vitro Azole Susceptibility | ||||
| Official Title ICMJE | Incidence of Oral Candidiasis, Prevalence of Candida Dubliniensis in HIV Patients and In-vitro Azole Susceptibility. (I.C.O.N.I.C.) | ||||
| 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. |
||||
| 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. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | HIV with or without AIDS defining illnesses at the Boulevard Comprehensive Care Center |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | January 2009 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00692783 | ||||
| Other Study ID Numbers ICMJE | UFJ2008-19 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Florida | ||||
| Study Sponsor ICMJE | University of Florida | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Florida | ||||
| Verification Date | February 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||