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Not yet recruitingNCT05876962Updated Jan 30, 2024

The Impact of Rapid Diagnostic Methods in the Diagnosis of Fungal Infections in Intensive Care Units of Assiut University Hospital

An observational study in Fungal Infection, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2024-01-30.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Sex
All
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Study 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 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.

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Conditions studied

  • Fungal Infection

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03

In context

Mycoses

260 studies on the registry are indexed under Mycoses; 37 are open to participants now.

This study's planned enrollment of 100 is below the median of 153 across 85 observational studies indexed under Mycoses.

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Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients of all age group and both sex with clinically suspected fungal infection at intensive care units of Assiut university hospital will be included.

Exclusion criteria

Exclusion Criteria:

  • -Patients who are on antifungal treatment and refuse to take part will be excluded from the study.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

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 28774702 ↗
  • Pappas 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 29749387 ↗
  • Mayer 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 23302789 ↗
  • Neppelenbroek 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 23679136 ↗
  • Vandeputte 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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05876962
Lead sponsor
Assiut University
Responsible party
Sara salah abd El mawgoud (Assistant lecturer, Assiut University) — Principal investigator
First posted
May 26, 2023
Start date
Jan 2024 (estimated)
Primary completion
May 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Jan 30, 2024

Study contacts

sara salah
Contact
fawazsara91@gmail.com
01092127787
asmaa omar
study chair · professor
mohamed zakaria
study chair · professor

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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