- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04775238
Effect of Metallic Nanoparticles on Nosocomial Bacteria
March 2, 2021 updated by: Nahed Fathallah Fahmy, Sohag University
Metallic Nanoparticles: Evaluation of Their Antibacterial, Antibiofilm and Synergistic Effect in Combination With Antibiotics on Nosocomial Bacteria
This research aims to study the properties of metallic nanoparticles"MNPs" (silver nanoparticles "AgNps" and copper nanoparticles "CuNps") on the 2 most common nosocomial bacteria which are highly resistant to antibiotics including Staphylococcus aureus and Pseudomonas aeruginosa, to evaluate the growth inhibiting properties of MNPs on all bacterial isolates, to evaluate the biofilm inhibitory effect on biofilm forming bacterial isolates and the synergistic effect of these MNPs in combination with antibiotics on the antibiotic resistant isolates.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
There is a rapid increase in the number of health care associated infections (HAIs) due to multi-drug resistant (MDR) bacterial strains which have a worse prognosis being associated with significant morbidity and mortality, particularly in critically ill patients.
The main problem with MDR strains is their limited treatment options, posing a major challenge for health care providers.The increasing utilization and immense studies of nanoparticles have brought new perspectives towards new antimicrobial material that could hinder the MDR bacteria pandemic currently faced.
Particularly, metallic nanoparticles exhibit strong biocidal properties on different bacterial species, including MDR bacteria.
Another important aspect of the antimicrobial properties of metallic nanoparticles is their potential to eradicate or inhibit microbial biofilm formation, which is an important virulence factor in many localized chronic infections.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
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
- Name: Nahed Fathallah, lecturer
- Phone Number: 01142283865
- Email: nanafahmy_783@yahoo.com
Study Contact Backup
- Name: Ekram Abdelrahman, lecturer
- Phone Number: +201004691692
- Email: dr.ekram.ar@gmail.com
Study Locations
-
-
-
Sohag, Egypt, 82524
- Recruiting
- faculty of medicine - Sohag university
-
Contact:
- Hassan Elnoamany, Professor
- Phone Number: +201002554984
- Email: hassan.noaman@med.sohag.edu.eg
-
Contact:
- Mona Fattouh, Professor
- Phone Number: +201009222054
- Email: monarahman2002@yahoo.co.uk
-
Sub-Investigator:
- Ekram Abdelrahman, lecturer
-
-
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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Urinary tract infections (UTI)
- Surgical site infections (SSI)
- Catheter related blood stream infection (CRBSI)
- Infected burns
- Chest infection
Exclusion Criteria:
- Patients less than 18 years.
- Community acquired infections
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1 (Staphylococcus aureus)
Staphylococcus aureus is an example of gram positive bacteria which is a strong biofilm producer and highly resistant to antibiotics.
Staphylococcus aureus will be exposed to silver nanoparticles and copper nanoparticles separately to study their antibacterial and biofilm inhibiting properties and their synergistic effect in combination with antibiotics.
|
AgNPs (19±5 nm)
Other Names:
CuNPs (150-350 nm)
Other Names:
|
Active Comparator: Group 2 (Pseudomonas aeruginosa )
Pseudomonas aeruginosa is an example of gram negative bacteria which is a strong biofilm producer and highly resistant to antibiotics.
Pseudomonas aeruginosa will be exposed to silver nanoparticles and copper nanoparticles separately to study their antibacterial and biofilm inhibiting properties and their synergistic effect in combination with antibiotics.
|
AgNPs (19±5 nm)
Other Names:
CuNPs (150-350 nm)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of the inhibition zone diameter by (mm) around wells containing silver nanoparticles on nutrient agar containing 105 cfu/ml (colony forming unit/ml) Staphylococcus aureus
Time Frame: 24 hours
|
Well diffusion method
|
24 hours
|
Measurement of the inhibition zone diameter by (mm) around wells containing silver nanoparticles on nutrient agar containing 105 cfu/ml Pseudomonas
Time Frame: 24 hours
|
Well diffusion method
|
24 hours
|
Measurement of the inhibition zone diameter by (mm) around wells containing copper nanoparticles on nutrient agar containing 105 cfu/ml Staphylococcus aureus
Time Frame: 24 hours
|
disc diffusion method
|
24 hours
|
Measurement of the inhibition zone diameter by (mm) around wells containing copper nanoparticles on nutrient agar containing 105 cfu/ml Pseudomonas
Time Frame: 24 hours
|
disc diffusion method
|
24 hours
|
Antibiofilm Activity:12 μg/mL of AgNPs will be added to 107 CFU/mL of Staph aureus. using a microtiter plate reader at 595 nm, biofilm scores: nonbiofilm forming (-), weak (+), moderate (++), and strong (+++)
Time Frame: 24 hours
|
Modified Tissue Culture Plate method (TCP):by ELISA
|
24 hours
|
Antibiofilm Activity:12 μg/mL of CuNPs will be added to 107 CFU/mL of Staph aureus. using a microtiter plate reader at 595 nm, biofilm scores: nonbiofilm forming (-), weak (+), moderate (++), and strong (+++)
Time Frame: 24 hours
|
Modified Tissue Culture Plate method (TCP):by ELISA
|
24 hours
|
Antibiofilm Activity:12 μg/mL of AgNPs will be added to 107 CFU/mL of Pseudomonas. Using a microtiter plate reader at 595 nm, biofilm scores: nonbiofilm forming (-), weak (+), moderate (++), and strong (+++)
Time Frame: 24 hours
|
Modified Tissue Culture Plate method (TCP):by ELISA
|
24 hours
|
Antibiofilm Activity:12 μg/mL of CuNPs will be added to 107 CFU/mL of Pseudomonas. Using a microtiter plate reader at 595 nm, biofilm scores: nonbiofilm forming (-), weak (+), moderate (++), and strong (+++)
Time Frame: 24 hours
|
Modified Tissue Culture Plate method (TCP):by ELISA
|
24 hours
|
Synergism with antibiotics: cefoxitin, Tetracyclin, Ciprofloxacin, Rifampin, Linezolide impregnated with 42.5 μg/mL AgNPs will be placed on nutrient agar containing 105 cfu/ml of Staph aureus. Inhibition zones will be measured (mm).
Time Frame: 24 hours
|
disc diffusion method
|
24 hours
|
Synergism with antibiotics: cefoxitin, Tetracyclin, Ciprofloxacin, Rifampin, Linezolide impregnated with 85 μg/mL CuNPs will be placed on nutrient agar containing 105 cfu/ml of Staph aureus. Inhibition zones will be measured (mm).
Time Frame: 24 hours
|
disc diffusion method
|
24 hours
|
Synergism with antibiotics:piperacillin-tazobactam, Aztreonam, Imipenem, Colistin, Ciprofloxacin impregnated with 42.5 μg/mL AgNPs will be placed on nutrient agar containing 105 cfu/ml of Pseudomonas. Inhibition zones will be measured (mm).
Time Frame: 24 hours
|
disc diffusion method
|
24 hours
|
Synergism with antibiotics:piperacillin-tazobactam, Aztreonam, Imipenem, Colistin ,Gentamicin, Ciprofloxacin impregnated with 85 μg/mL CuNPs will be placed on nutrient agar containing 105 cfu/ml of Pseudomonas. Inhibition zones will be measured (mm).
Time Frame: 24 hours
|
disc diffusion method
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nahed Fathallah, lecturer, Sohag University
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 (Actual)
February 27, 2021
Primary Completion (Anticipated)
June 20, 2021
Study Completion (Anticipated)
July 1, 2021
Study Registration Dates
First Submitted
February 22, 2021
First Submitted That Met QC Criteria
February 25, 2021
First Posted (Actual)
March 1, 2021
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
March 2, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-21-02-21
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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