NCT05368948

Brief Summary

  • Identification of different types of fungi.
  • Determine sensitivity the profile and the resistance pattern of the clinical isolates against antifungal.
  • Determine the antifungal effects of defensin, cathelicidin and histatins and their effects on biofilm formation and resistant isolates.

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 Dec 2022

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

April 14, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

April 14, 2022

Last Update Submit

May 6, 2022

Conditions

Fungal Infection

Keywords

antimicrobial peptides

Outcome Measures

Primary Outcomes (1)

  • 1.to determine the level at which inhibition of fungi occurs

    Determination of defensin ,cathelicidin and histatin is done using broth microdilution method . The procedure involves preparation of twofold dilutions in sterile heart brain broth inside the wells of 96-well microplate.The highest dilution of samples without visible growth after 24 h incubation at 37 °C was considered as minimum inhibitory concentration. . A change in color from blue to pink indicates the growth of bacteria .

    6 months

Secondary Outcomes (1)

  • measure the percentage of decrease in biofilm formation

    6 month

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- Samples obtained from patients with cutaneous fungal infection and systemic fungal infection

You may qualify if:

  • \- Samples obtained from patients with cutaneous fungal infection and systemic fungal infection

You may not qualify if:

  • Patients diagnosed to be viral or bacterial infections.
  • Patients on antibiotic or antifungal treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Lionakis MS, Levitz SM. Host Control of Fungal Infections: Lessons from Basic Studies and Human Cohorts. Annu Rev Immunol. 2018 Apr 26;36:157-191. doi: 10.1146/annurev-immunol-042617-053318. Epub 2017 Dec 13.

    PMID: 29237128BACKGROUND

  • Chowdhary A, Sharma C, Meis JF. Azole-Resistant Aspergillosis: Epidemiology, Molecular Mechanisms, and Treatment. J Infect Dis. 2017 Aug 15;216(suppl_3):S436-S444. doi: 10.1093/infdis/jix210.

    PMID: 28911045BACKGROUND

  • Perlin DS, Rautemaa-Richardson R, Alastruey-Izquierdo A. The global problem of antifungal resistance: prevalence, mechanisms, and management. Lancet Infect Dis. 2017 Dec;17(12):e383-e392. doi: 10.1016/S1473-3099(17)30316-X. Epub 2017 Jul 31.

    PMID: 28774698BACKGROUND

  • Huan Y, Kong Q, Mou H, Yi H. Antimicrobial Peptides: Classification, Design, Application and Research Progress in Multiple Fields. Front Microbiol. 2020 Oct 16;11:582779. doi: 10.3389/fmicb.2020.582779. eCollection 2020.

    PMID: 33178164BACKGROUND

  • Cools TL, Struyfs C, Drijfhout JW, Kucharikova S, Lobo Romero C, Van Dijck P, Ramada MHS, Bloch C Jr, Cammue BPA, Thevissen K. A Linear 19-Mer Plant Defensin-Derived Peptide Acts Synergistically with Caspofungin against Candida albicans Biofilms. Front Microbiol. 2017 Oct 20;8:2051. doi: 10.3389/fmicb.2017.02051. eCollection 2017.

    PMID: 29104569BACKGROUND

  • Oshiro KGN, Rodrigues G, Monges BED, Cardoso MH, Franco OL. Bioactive Peptides Against Fungal Biofilms. Front Microbiol. 2019 Oct 4;10:2169. doi: 10.3389/fmicb.2019.02169. eCollection 2019.

    PMID: 31681179BACKGROUND

  • Sathoff AE, Samac DA. Antibacterial Activity of Plant Defensins. Mol Plant Microbe Interact. 2019 May;32(5):507-514. doi: 10.1094/MPMI-08-18-0229-CR. Epub 2019 Mar 29.

    PMID: 30501455BACKGROUND

  • Scarsini M, Tomasinsig L, Arzese A, D'Este F, Oro D, Skerlavaj B. Antifungal activity of cathelicidin peptides against planktonic and biofilm cultures of Candida species isolated from vaginal infections. Peptides. 2015 Sep;71:211-21. doi: 10.1016/j.peptides.2015.07.023. Epub 2015 Jul 31.

    PMID: 26238597BACKGROUND

MeSH Terms

Conditions

Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • amal mohamad hosni, lecturer

    Assiut University

    STUDY DIRECTOR

  • asmaa omar ahmed, assistant professor

    Assiut University

    STUDY CHAIR

  • mohamad zakaria abd elrahman, professor

    Assiut University

    STUDY CHAIR

Central Study Contacts

sara salah abd el mawgoud, assistant lecturer

CONTACT

01092127787fawazsara@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer in clinical pathology department

Study Record Dates

First Submitted

April 14, 2022

First Posted

May 10, 2022

Study Start

December 1, 2022

Primary Completion

February 1, 2023

Study Completion

June 1, 2023

Last Updated

May 10, 2022

Record last verified: 2022-05