Candida InfectionNCT07245563
Biofilm Formation and Antifungal Resistance in Candida Species
An observational study of Candida Infection, run by Assiut University.
Trial summary
1. To determine the susceptibility pattern of our local isolated Candida strains which is essential for optimal management of fungal infection. 2. Detection of biofilm formation by conventional and molecular methods 3. Comparison between C. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Candida Infection
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to 12 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients admitted to hematology intensive care
Who may be able to join
- Eligible participants in the study were those with invasive infection and had one or more of this criteria :
- oSuppressed general body immunity.
- oSuppressed local body immunity as a result of trauma or invasive procedures.
- oResistant to antibiotic therapy.
- oNegative samples for bacterial examination and culture.
- Critical life threatening infect
Who cannot join
- Patients who received antifungal therapy within 3 days prior to sample collection.
- Resistant to antibiotic therapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Biofilm Formation and Antifungal Resistance in Candida Species: A Comparative Study of Albicans and Non Albicans Strains in Hematology ICU.
- To determine the susceptibility pattern of our local isolated Candida strains which is essential for optimal management of fungal infection.
- Detection of biofilm formation by conventional and molecular methods
- Comparison between C. albicans and non-albicans in the prevalence of biofilm formation and biofilm -forming genes
- Find the association between antifungal resistance and biofilm formation in candida strains isolated from patients
- Determination of clinical factors associated with occurrence of infections.
Read the detailed description
Candida spp are the fourth cause of nosocomial blood stream infections and had a 37% mortality rate within 30-day duration. Early diagnosis of Candida invasive infections reduces the mortality rate from 40% to 15% after therapy .There are several Candida species such as Candida albicans , Candida glabrata but C. albicans remains the most frequent species isolated there is an ongoing shift from C. albicans to non-albicans. Was reported by several countries. C. albicans, C. tropicalis, C. parapsilosis,C. krusei and C. glabrata are responsible for over 90% of cases of candidal infection .Several pathogenic virulence factors are encoded by C. albicans genes and assist the fungus to invade the host tissues leading to infections as the capacity of C. albicans to change from the budding yeast form to filamentous form .Many microbes, including yeasts, form biofilms as one of the major virulence factors. Candida infections often get therapeutic failure, mostly as a result of antifungal resistance that is caused by several mechanisms including biofilm production as biofilm- producing strains show significant increased resistance to antifungal drugs and host immunity.
Candida auris is an emergent pathogen that was first described in Japan. C. auris can be challenging to identify in the laboratory using conventional. Importantly, C. auris isolates are resistant to fluconazole and frequently show multidrug resistance.C. auris has a high capacity for dissemination via contaminated surfaces or horizontal patient-to-patient transfer, which is unusual in other Candida species.
- Conditions
- Candida Infection
- Medical subject headings
- Candidiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses the prevalence of candida species as a cause of infection in patient in hematology intinsive care unit
Measured: 1 year
To asses the prevalence of genes responsible for biofilm formation in different candida species
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start20 Dec 2025 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion12 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candida InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatoallah khaled abdelhady, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245563
- Sponsor's protocol ID
- candida species identification
- Status last verified
- Nov 2025
- First submitted
- 2 Oct 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofilm Formation and Antifungal Resistance in Candida Species: A Comparative Study of Albicans and Non Albicans Strains in Hematology ICU.
- ClinicalTrials.gov ID
- NCT07245563
- Acronym / sponsor ID
- candida species identification
- Conditions
- Candida Infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 12 Oct 2026 (estimated)
- First posted
- 24 Nov 2025 (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.
- To determine the susceptibility pattern of our local isolated Candida strains which is essential for optimal management of fungal infection.
- Detection of biofilm formation by conventional and molecular methods
- Comparison between C. albicans and non-albicans in the prevalence of biofilm formation and biofilm -forming genes
- Find the association between antifungal resistance and biofilm formation in candida strains isolated from patients
- Determination of clinical factors associated with occurrence of infections.
Detailed description
Candida spp are the fourth cause of nosocomial blood stream infections and had a 37% mortality rate within 30-day duration. Early diagnosis of Candida invasive infections reduces the mortality rate from 40% to 15% after therapy .There are several Candida species such as Candida albicans , Candida glabrata but C. albicans remains the most frequent species isolated there is an ongoing shift from C. albicans to non-albicans. Was reported by several countries. C. albicans, C. tropicalis, C. parapsilosis,C. krusei and C. glabrata are responsible for over 90% of cases of candidal infection .Several pathogenic virulence factors are encoded by C. albicans genes and assist the fungus to invade the host tissues leading to infections as the capacity of C. albicans to change from the budding yeast form to filamentous form .Many microbes, including yeasts, form biofilms as one of the major virulence factors. Candida infections often get therapeutic failure, mostly as a result of antifungal resistance that is caused by several mechanisms including biofilm production as biofilm- producing strains show significant increased resistance to antifungal drugs and host immunity.
Candida auris is an emergent pathogen that was first described in Japan. C. auris can be challenging to identify in the laboratory using conventional. Importantly, C. auris isolates are resistant to fluconazole and frequently show multidrug resistance.C. auris has a high capacity for dissemination via contaminated surfaces or horizontal patient-to-patient transfer, which is unusual in other Candida species.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients admitted to hematology intensive care
Key inclusion criteria (6 listed)
- Eligible participants in the study were those with invasive infection and had one or more of this criteria :
- oSuppressed general body immunity.
- oSuppressed local body immunity as a result of trauma or invasive procedures.
- oResistant to antibiotic therapy.
- oNegative samples for bacterial examination and culture.
Key exclusion criteria (2 listed)
- Patients who received antifungal therapy within 3 days prior to sample collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To asses the prevalence of candida species as a cause of infection in patient in hematology intinsive care unit
Time frame: 1 year
To asses the prevalence of genes responsible for biofilm formation in different candida species
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Candida Infection, run by Assiut University.
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 6 inclusion and 2 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: opening soon, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mennat-allah khaled abdelhady (00201151387078, roserena2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To asses the prevalence of candida species as a cause of infection in patient in hematology intinsive care unit (time frame: 1 year). The study lists 2 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 24 Nov 2025.