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

January 29, 2024 updated by: Sara salah abd El mawgoud, Assiut University
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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: asmaa omar, professor
  • Study Chair: mohamed zakaria, professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diagnosis of fungal infection

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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