Fungal InfectionNCT05876962
The Impact of Rapid Diagnostic Methods in the Diagnosis of Fungal Infections in Intensive Care Units of Assiut University Hospital
An observational study of Fungal Infection, run by Assiut University.
Trial summary
The diagnosis of invasive fungal disease remains challenging in the clinical laboratory. The use of matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) for the identification of filamentous fungi as well as its application for antifungal resistance testing and strain typing Will… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fungal Infection
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of all age group and both sex with clinically suspected fungal infection at intensive care units of Assiut university hospital will be included
Who may be able to join
- Patients of all age group and both sex with clinically suspected fungal infection at intensive care units of Assiut university hospital will be included.
Who cannot join
- -Patients who are on antifungal treatment and refuse to take part will be excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
The diagnosis of invasive fungal disease remains challenging in the clinical laboratory. The use of matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) for the identification of filamentous fungi as well as its application for antifungal resistance testing and strain typing Will be evaluated.
Read the detailed description
Fungal infections are life-threatening opportunistic infections that have emerged as a major cause of morbidity and mortality in critically ill patients. Yeast infections,mainly Candida spp., remain much more frequent than mold infections. Among mold infections, Aspergillus spp. represent the most frequently isolated filamentous fungi in these circumstances .Candida species are the most common cause of nosocomial fungal infections and the fourth most common source of hospital-acquired infections. Candidiasis is an infection caused by Candida, mostly limited to the skin, nails and mucous membranes. However, it can cause serious systemic infections. Candidiasis is an opportunistic infection occurring in presence of predisposing factors like extensive and prolonged administration of broad-spectrum antimicrobials, corticosteroids, immunosuppressive agents and cytotoxic drugs, diabetes mellitus, HIV, chronic renal failure, haemodialysis, renal transplantation or indwelling urinary catheter.The pathogenicity of Candida spp. is related to a combination of microbial factors such as their ability to grow at 37°C, polymorphism, biofilm formation, hydrolytic enzyme secretion, and phenotypic switching. Candida species are identified by different phenotypic methods including examination of their morphological features, analysis of their ability of carbohydrates assimilation and/or fermentation, and their ability of assimilating different nitrogen compounds. Numerous antifungal classes are used to treat Candida infections; polyenes, azoles, echinocandins and allylamines. These antifungals are used with varying efficacy depending on the type, site of infection and the susceptibility of different Candida species. Azoles are the most frequently used antifungal drugs to treat Candida infections as they achieve high success rates even over short durations of therapy. However, resistance among previously susceptible Candida species has emerged following the expanded use of antifungal agents. Antifungal susceptibility testing methods including broth dilution, disk diffusion and E test are now available with species-specific breakpoints developed by The Clinical and Laboratory Standards Institute (CLSI) for multiple antifungal agents.
- Conditions
- Fungal Infection
- Medical subject headings
- Mycoses
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotypically identify percentage of different fungal infections isolated from various clinical specimens in intensive care units. and Assess their antifungal susceptibility pattern.
Assess the accuracy of Maldi-TOF in diagnosis of fungal infections
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study startJan 2024 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fungal 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara salah abd El mawgoud, Assiut University
- Investigators
- asmaa omar, Study chair, professormohamed zakaria, Study chair, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876962
- Sponsor's protocol ID
- Diagnosis of fungal infection
- Status last verified
- Jul 2023
- First submitted
- 17 May 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Colombo AL, de Almeida Junior JN, Slavin MA, Chen SC, Sorrell TC. Candida and invasive mould diseases in non-neutropenic critically ill patients and patients with haematological cancer. Lancet Infect Dis. 2017 Nov;17(11):e344-e356. doi: 10.1016/S1473-3099(17)30304-3. Epub 2017 Jul 31.
PubMed 28774702Pappas PG, Lionakis MS, Arendrup MC, Ostrosky-Zeichner L, Kullberg BJ. Invasive candidiasis. Nat Rev Dis Primers. 2018 May 11;4:18026. doi: 10.1038/nrdp.2018.26.
PubMed 29749387Mayer FL, Wilson D, Hube B. Candida albicans pathogenicity mechanisms. Virulence. 2013 Feb 15;4(2):119-28. doi: 10.4161/viru.22913. Epub 2013 Jan 9.
PubMed 23302789Neppelenbroek KH, Seo RS, Urban VM, Silva S, Dovigo LN, Jorge JH, Campanha NH. Identification of Candida species in the clinical laboratory: a review of conventional, commercial, and molecular techniques. Oral Dis. 2014 May;20(4):329-44. doi: 10.1111/odi.12123. Epub 2013 May 16.
PubMed 23679136Vandeputte P, Ferrari S, Coste AT. Antifungal resistance and new strategies to control fungal infections. Int J Microbiol. 2012;2012:713687. doi: 10.1155/2012/713687. Epub 2011 Dec 1.
PubMed 22187560
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Rapid Diagnostic Methods in the Diagnosis of Fungal Infections in Intensive Care Units of Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05876962
- Acronym / sponsor ID
- Diagnosis of fungal infection
- Conditions
- Fungal Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 May 2023 (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.
The diagnosis of invasive fungal disease remains challenging in the clinical laboratory. The use of matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) for the identification of filamentous fungi as well as its application for antifungal resistance testing and strain typing Will be evaluated.
Detailed description
Fungal infections are life-threatening opportunistic infections that have emerged as a major cause of morbidity and mortality in critically ill patients. Yeast infections,mainly Candida spp., remain much more frequent than mold infections. Among mold infections, Aspergillus spp. represent the most frequently isolated filamentous fungi in these circumstances .Candida species are the most common cause of nosocomial fungal infections and the fourth most common source of hospital-acquired infections. Candidiasis is an infection caused by Candida, mostly limited to the skin, nails and mucous membranes. However, it can cause serious systemic infections. Candidiasis is an opportunistic infection occurring in presence of predisposing factors like extensive and prolonged administration of broad-spectrum antimicrobials, corticosteroids, immunosuppressive agents and cytotoxic drugs, diabetes mellitus, HIV, chronic renal failure, haemodialysis, renal transplantation or indwelling urinary catheter.The pathogenicity of Candida spp. is related to a combination of microbial factors such as their ability to grow at 37°C, polymorphism, biofilm formation, hydrolytic enzyme secretion, and phenotypic switching. Candida species are identified by different phenotypic methods including examination of their morphological features, analysis of their ability of carbohydrates assimilation and/or fermentation, and their ability of assimilating different nitrogen compounds. Numerous antifungal classes are used to treat Candida infections; polyenes, azoles, echinocandins and allylamines. These antifungals are used with varying efficacy depending on the type, site of infection and the susceptibility of different Candida species. Azoles are the most frequently used antifungal drugs to treat Candida infections as they achieve high success rates even over short durations of therapy. However, resistance among previously susceptible Candida species has emerged following the expanded use of antifungal agents. Antifungal susceptibility testing methods including broth dilution, disk diffusion and E test are now available with species-specific breakpoints developed by The Clinical and Laboratory Standards Institute (CLSI) for multiple antifungal agents.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of all age group and both sex with clinically suspected fungal infection at intensive care units of Assiut university hospital will be included
Key inclusion criteria (1 listed)
- Patients of all age group and both sex with clinically suspected fungal infection at intensive care units of Assiut university hospital will be included.
Key exclusion criteria (1 listed)
- -Patients who are on antifungal treatment and refuse to take part will be excluded from the study.
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
Phenotypically identify percentage of different fungal infections isolated from various clinical specimens in intensive care units. and Assess their antifungal susceptibility pattern.
Time frame: baseline
Assess the accuracy of Maldi-TOF in diagnosis of fungal infections
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 28774702Colombo AL, de Almeida Junior JN, Slavin MA, Chen SC, Sorrell TC. Candida and invasive mould diseases in non-neutropenic critically ill patients and patients with haematological cancer. Lancet Infect Dis. 2017 Nov;17(11):e344-e356. doi: 10.1016/S1473-3099(17)30304-3. Epub 2017 Jul 31.
- Background: PubMed 29749387Pappas PG, Lionakis MS, Arendrup MC, Ostrosky-Zeichner L, Kullberg BJ. Invasive candidiasis. Nat Rev Dis Primers. 2018 May 11;4:18026. doi: 10.1038/nrdp.2018.26.
- Background: PubMed 23302789Mayer FL, Wilson D, Hube B. Candida albicans pathogenicity mechanisms. Virulence. 2013 Feb 15;4(2):119-28. doi: 10.4161/viru.22913. Epub 2013 Jan 9.
- Background: PubMed 23679136Neppelenbroek KH, Seo RS, Urban VM, Silva S, Dovigo LN, Jorge JH, Campanha NH. Identification of Candida species in the clinical laboratory: a review of conventional, commercial, and molecular techniques. Oral Dis. 2014 May;20(4):329-44. doi: 10.1111/odi.12123. Epub 2013 May 16.
- Background: PubMed 22187560Vandeputte P, Ferrari S, Coste AT. Antifungal resistance and new strategies to control fungal infections. Int J Microbiol. 2012;2012:713687. doi: 10.1155/2012/713687. Epub 2011 Dec 1.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
asmaa omar study chair
professor
mohamed zakaria study chair
professor
Questions about this trial
What is this clinical trial studying?
An observational study of Fungal 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 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: status not confirmed, as of the sponsor's last update on 30 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sara salah (01092127787, fawazsara91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotypically identify percentage of different fungal infections isolated from various clinical specimens in intensive care units. and Assess their antifungal susceptibility pattern. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05876962, which also lists 5 linked publications.
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 30 Jan 2024.