Fungal InfectionNCT05368948
The Assessment of Antimicrobial Peptides Against Fungal Infection
An observational study of Fungal Infection, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fungal Infection
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Jun 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - Samples obtained from patients with cutaneous fungal infection and systemic fungal infection
Who may be able to join
- - Samples obtained from patients with cutaneous fungal infection and systemic fungal infection
Who cannot join
- Patients diagnosed to be viral or bacterial infections.
- Patients on antibiotic or antifungal treatment
Trial locations and contacts
No sites are listed yet.
About this study
- 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.
Read the detailed description
Fungal infections are recurrent in the clinical environment and, annually, affect 25% of the general population worldwide, causing high morbidity and mortality rates. The indiscriminate use of broad-spectrum antibiotics, along with parenteral nutrition, permanent catheters, chemotherapy and radiotherapy, as well as immunosuppression in patients, is the most important predisposing factors for invasive fungal infections. Fungi are classified according to their morphologies, including yeasts (Cryptococcus spp.), fungi with branched hyphae (Aspergillus spp.), as well as fungi with both morphologies (yeasts and pseudohyphae, as for Candida spp.), which have all been associated with fungal infections in humans.
Fungal biofilms are communities of adherent cells surrounded by an extracellular matrix. These biofilms are commonly found during infection caused by a variety of fungal pathogens. Clinically, biofilm infections can be extremely difficult to eradicate due to their resistance to antifungals and host defenses. Biofilm formation can protect fungal pathogens from many aspects of the innate immune system, including killing by neutrophils and monocytes. Currently, antifungal therapies are scarce and include only four classes of antifungal agents, polyenes, triazoles, echinocandins and flucytosine . The misuse of antifungal agents over the last two decades contributed to antifungal resistance development.Fungal resistance emergence has important clinical implications, as it limits the already small arsenal of antifungal agents, raising the idea of a "post-antifungal" era. Antimicrobial peptides (AMPs) have emerged as new biopharmaceuticals to prevent or treat fungal infections. AMPs are a class of small peptides that widely exist in nature and are an important part of the innate immune system of different organisms. AMPs have a wide range of inhibitory effects against bacteria, fungi, parasites and viruses . Defensins comprise antifungal peptides isolated from various organisms, including plants and mammals . Plant defensins are cationic and have 45-54 amino acids in length. These peptides have typically been isolated from seeds, but can also be found in other plant tissues including leaves, flowers, roots and stems. Most of the plant defensins identified so far have eight cysteine residues that favor structural stability by the formation of four disulfide bonds . In addition, structural studies have shown that plant defensins comprise a triple β-sheet with a parallel helix. Regarding their biological properties, plant defensins have shown activity against bacteria and fungi, both in their planktonic and biofilm modes of growth . Peptides from the cathelicidin family have been isolated from different species of mammals and exhibit broad-spectrum activities against fungi. Cathelicidins are characterized as cationic peptides, consisting of 12-80 amino acids that adopt an α-helix or β-sheet as secondary structures, most of which have 23-37 amino acid residues distributed in amphipathic helices, including LL-37. The activities of LL-37 have been investigated against Candida spp. strains. Human salivary histatins are a group of small histidine-rich proteins constituted from 7 to 38 amino acids first isolated from human parotid saliva. In general, histatins are a multifunctional group of proteins with antimicrobial properties that vary from broad-spectrum to moderate activities. Moreover, histatins have been reported for their effective antifungal activity
- Conditions
- Fungal Infection
- Keywords
- antimicrobial peptides
- Medical subject headings
- Mycoses
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 6 months
Secondary outcomes (1)
measure the percentage of decrease in biofilm formation
The ability of fungal isolates to adhere and to form biofilms in a 96-well plate will be done using the microtiter plate assay.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study startDec 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Cross-sectional
- 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
- amal mohamad hosni, lecturer, Study director, Assiut Universityasmaa omar ahmed, assistant professor, Study chair, Assiut Universitymohamad zakaria abd elrahman, professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368948
- Sponsor's protocol ID
- antimicrobial peptides
- Status last verified
- May 2022
- First submitted
- 14 Apr 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29237128Chowdhary 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.
PubMed 28911045Perlin 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.
PubMed 28774698Huan 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.
PubMed 33178164Cools 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.
PubMed 29104569Oshiro 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.
PubMed 31681179Sathoff 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.
PubMed 30501455Scarsini 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.
PubMed 26238597
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Antimicrobial Peptides Against Fungal Infection
- ClinicalTrials.gov ID
- NCT05368948
- Acronym / sponsor ID
- antimicrobial peptides
- Conditions
- Fungal Infection
- Keywords
- antimicrobial peptides
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 10 May 2022 (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.
- 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.
Detailed description
Fungal infections are recurrent in the clinical environment and, annually, affect 25% of the general population worldwide, causing high morbidity and mortality rates. The indiscriminate use of broad-spectrum antibiotics, along with parenteral nutrition, permanent catheters, chemotherapy and radiotherapy, as well as immunosuppression in patients, is the most important predisposing factors for invasive fungal infections. Fungi are classified according to their morphologies, including yeasts (Cryptococcus spp.), fungi with branched hyphae (Aspergillus spp.), as well as fungi with both morphologies (yeasts and pseudohyphae, as for Candida spp.), which have all been associated with fungal infections in humans.
Fungal biofilms are communities of adherent cells surrounded by an extracellular matrix. These biofilms are commonly found during infection caused by a variety of fungal pathogens. Clinically, biofilm infections can be extremely difficult to eradicate due to their resistance to antifungals and host defenses. Biofilm formation can protect fungal pathogens from many aspects of the innate immune system, including killing by neutrophils and monocytes. Currently, antifungal therapies are scarce and include only four classes of antifungal agents, polyenes, triazoles, echinocandins and flucytosine . The misuse of antifungal agents over the last two decades contributed to antifungal resistance development.Fungal resistance emergence has important clinical implications, as it limits the already small arsenal of antifungal agents, raising the idea of a "post-antifungal" era. Antimicrobial peptides (AMPs) have emerged as new biopharmaceuticals to prevent or treat fungal infections. AMPs are a class of small peptides that widely exist in nature and are an important part of the innate immune system of different organisms. AMPs have a wide range of inhibitory effects against bacteria, fungi, parasites and viruses . Defensins comprise antifungal peptides isolated from various organisms, including plants and mammals . Plant defensins are cationic and have 45-54 amino acids in length. These peptides have typically been isolated from seeds, but can also be found in other plant tissues including leaves, flowers, roots and stems. Most of the plant defensins identified so far have eight cysteine residues that favor structural stability by the formation of four disulfide bonds . In addition, structural studies have shown that plant defensins comprise a triple β-sheet with a parallel helix. Regarding their biological properties, plant defensins have shown activity against bacteria and fungi, both in their planktonic and biofilm modes of growth . Peptides from the cathelicidin family have been isolated from different species of mammals and exhibit broad-spectrum activities against fungi. Cathelicidins are characterized as cationic peptides, consisting of 12-80 amino acids that adopt an α-helix or β-sheet as secondary structures, most of which have 23-37 amino acid residues distributed in amphipathic helices, including LL-37. The activities of LL-37 have been investigated against Candida spp. strains. Human salivary histatins are a group of small histidine-rich proteins constituted from 7 to 38 amino acids first isolated from human parotid saliva. In general, histatins are a multifunctional group of proteins with antimicrobial properties that vary from broad-spectrum to moderate activities. Moreover, histatins have been reported for their effective antifungal activity
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Samples obtained from patients with cutaneous fungal infection and systemic fungal infection
Key inclusion criteria (1 listed)
- - Samples obtained from patients with cutaneous fungal infection and systemic fungal infection
Key exclusion criteria (2 listed)
- Patients diagnosed to be viral or bacterial infections.
- Patients on antibiotic or antifungal treatment
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
1.to determine the level at which inhibition of fungi occurs
Time frame: 6 months
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 .
1 secondary outcome
measure the percentage of decrease in biofilm formation
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Background: PubMed 29237128Lionakis 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.
- Background: PubMed 28911045Chowdhary 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.
- Background: PubMed 28774698Perlin 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.
- Background: PubMed 33178164Huan 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.
- Background: PubMed 29104569Cools 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.
- Background: PubMed 31681179Oshiro 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.
- Background: PubMed 30501455Sathoff 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.
- Background: PubMed 26238597Scarsini 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.
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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.
amal mohamad hosni, lecturer study director
Assiut University
asmaa omar ahmed, assistant professor study chair
Assiut University
mohamad zakaria abd elrahman, professor study chair
Assiut University
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 2 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 10 May 2022. 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 abd el mawgoud, assistant lecturer (01092127787, fawazsara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.to determine the level at which inhibition of fungi occurs (time frame: 6 months). 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 NCT05368948, which also lists 8 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 10 May 2022.