- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04121871
Molecular Characterization of Candida Auris (OC)
October 25, 2020 updated by: Jafir Hussain Shirazi, Islamia University of Bahawalpur
Formulation Development and In-Vitro Studies of Efficacy of Botanical Extracts Against Candida Auris
Candida auris is emerging fungal opportunistic pathogen in developing countries.
Much studies has been conducted on Candida albicans.
there was a dire need to investigate this alarming threat.
Our hypothesis is that by recording the patients diagnosed with oropharygneal candidiasis and collecting clinical swab samples from these patients will be fruitful if microbiological isolation, identification and molecular characterization will be done.
So this is the first study on C. auris in south punjab, Pakistan.
Aim of this study is to collect epidemiological data of C. auris.
Study Overview
Study Type
Observational
Enrollment (Actual)
384
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab
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Bahawalpur, Punjab, Pakistan, 63100
- Bahawal Victoria Hospital Bahawalpur
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Bahawalpur, Punjab, Pakistan, 63100
- Civil Hospital Jhangi Wala Road Bahawalpur
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 100 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All individuals are equally eligible to be selected in the study
Description
Inclusion Criteria:
- Pre-diagnosed Patients of both gender from pre-selected localities
Exclusion Criteria:
- Healthy individuals or individuals having no oral fungal infection individuals above 100 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of C. auris
Time Frame: From November 15, 2019 to February 29, 2020
|
patients from selected localities will be recorded along with total patients in that category, prevalence will be calculated on the record collected from specified duration of study
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From November 15, 2019 to February 29, 2020
|
|
Seasonality of C. auris infection
Time Frame: From November 15, 2019 to February 29, 2020
|
Number of patients recorded during different months will be the source of calculation of seasonality index of the C. auris infection
|
From November 15, 2019 to February 29, 2020
|
|
Drug susceptibility
Time Frame: From November 15, 2019 to February 29, 2020
|
Antifungal drug discs will be used for assessing the antfungal drugs susceptibility
|
From November 15, 2019 to February 29, 2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jafi H Shirazi, M.Phil, The islamia university of Bahawalpur
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2019
Primary Completion (Actual)
February 29, 2020
Study Completion (Actual)
February 29, 2020
Study Registration Dates
First Submitted
October 7, 2019
First Submitted That Met QC Criteria
October 9, 2019
First Posted (Actual)
October 10, 2019
Study Record Updates
Last Update Posted (Actual)
October 27, 2020
Last Update Submitted That Met QC Criteria
October 25, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Oral Fungal Infection
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Individual privacy is prime important, hence data will not be shared
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.