Oral Fungal InfectionOCNCT04121871
Molecular Characterization of Candida Auris
An observational study of Oral Fungal Infection, run by Islamia University of Bahawalpur at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Oral Fungal Infection
- How many people
- 384 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Nov 2019to 29 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All individuals are equally eligible to be selected in the study
Who may be able to join
- Pre-diagnosed Patients of both gender from pre-selected localities
Who cannot join
- Healthy individuals or individuals having no oral fungal infection individuals above 100 years of age
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Bahawal Victoria Hospital Bahawalpur
Bahawalpur, Punjab Province, 63100
Civil Hospital Jhangi Wala Road Bahawalpur
Bahawalpur, Punjab Province, 63100
About this study
Official title: 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.
- Conditions
- Oral Fungal Infection
- Being tested
- No intervention
- Keywords
- Candida auris, Oral Fungal Infection, Candidiasis
- Medical subject headings
- Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Not required
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From November 15, 2019 to February 29, 2020
Drug susceptibility
Antifungal drug discs will be used for assessing the antfungal drugs susceptibility
Measured: From November 15, 2019 to February 29, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start15 Nov 2019
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Fungal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamia University of Bahawalpur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jafir Hussain Shirazi, Islamia University of Bahawalpur
- Investigators
- Jafi H Shirazi, M.Phil, Principal investigator, The Islamia University of Bahawalpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121871
- Sponsor's protocol ID
- Oral Fungal Infection
- Acronym
- OC
- Status last verified
- Oct 2020
- First submitted
- 7 Oct 2019
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual privacy is prime important, hence data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formulation Development and In-Vitro Studies of Efficacy of Botanical Extracts Against Candida Auris
- ClinicalTrials.gov ID
- NCT04121871
- Acronym / sponsor ID
- OC / Oral Fungal Infection
- Conditions
- Oral Fungal Infection
- Keywords
- Candida auris, Oral Fungal Infection, Candidiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Islamia University of BahawalpurUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals are equally eligible to be selected in the study
Key inclusion criteria (1 listed)
- Pre-diagnosed Patients of both gender from pre-selected localities
Key exclusion criteria (1 listed)
- Healthy individuals or individuals having no oral fungal infection individuals above 100 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNot required | Other | – |
Primary outcome
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
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
Drug susceptibility
Time frame: From November 15, 2019 to February 29, 2020
Antifungal drug discs will be used for assessing the antfungal drugs susceptibility
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Individual participant dataSharing planned: No. Individual privacy is prime important, hence data will not be shared
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jafi H Shirazi, M.Phil principal investigator
The Islamia University of Bahawalpur
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Fungal Infection, run by Islamia University of Bahawalpur at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of C. auris (time frame: From November 15, 2019 to February 29, 2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020; AzTrials last refreshed its copy on 1 Nov 2026.