NCT05876962

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 30, 2024

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

May 17, 2023

Last Update Submit

January 29, 2024

Conditions

Outcome Measures

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

    baseline

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 28774702BACKGROUND
  • 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.

    PMID: 29749387BACKGROUND
  • 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.

    PMID: 23302789BACKGROUND
  • 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.

    PMID: 23679136BACKGROUND
  • 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.

    PMID: 22187560BACKGROUND

MeSH Terms

Conditions

Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • asmaa omar

    professor

    STUDY CHAIR
  • mohamed zakaria

    professor

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

May 17, 2023

First Posted

May 26, 2023

Study Start

January 1, 2024

Primary Completion

May 1, 2024

Study Completion

December 1, 2024

Last Updated

January 30, 2024

Record last verified: 2023-07