NCT04121871

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
384

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

October 7, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

October 7, 2019

Last Update Submit

October 25, 2020

Conditions

Keywords

Candida aurisOral Fungal InfectionCandidiasis

Outcome Measures

Primary Outcomes (3)

  • Prevalence of C. auris

    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

    From November 15, 2019 to February 29, 2020

  • Seasonality of C. auris infection

    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

    Antifungal drug discs will be used for assessing the antfungal drugs susceptibility

    From November 15, 2019 to February 29, 2020

Interventions

Not required

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All individuals are equally eligible to be selected in the study

You may qualify if:

  • Pre-diagnosed Patients of both gender from pre-selected localities

You may not qualify if:

  • Healthy individuals or individuals having no oral fungal infection individuals above 100 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bahawal Victoria Hospital Bahawalpur

Bahawalpur, Punjab Province, 63100, Pakistan

Location

Civil Hospital Jhangi Wala Road Bahawalpur

Bahawalpur, Punjab Province, 63100, Pakistan

Location

Biospecimen

Retention: NONE RETAINED

Clinical oral swab samples from infected patients will be collected

MeSH Terms

Conditions

Candidiasis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Study Officials

  • Jafi H Shirazi, M.Phil

    The Islamia University of Bahawalpur

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 7, 2019

First Posted

October 10, 2019

Study Start

November 15, 2019

Primary Completion

February 29, 2020

Study Completion

February 29, 2020

Last Updated

October 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Individual privacy is prime important, hence data will not be shared

Locations