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Effect of Metallic Nanoparticles on Nosocomial Bacteria

Primary Purpose

Nosocomial Infections

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Silver nanoparticles
Copper nanoparticles
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nosocomial Infections focused on measuring Staphylococcus aureus, Pseudomonas, silver nanoparticles, copper nanoparticles

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of medicine - sohag universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1 (Staphylococcus aureus)

Group 2 (Pseudomonas aeruginosa )

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
Well diffusion method
Measurement of the inhibition zone diameter by (mm) around wells containing silver nanoparticles on nutrient agar containing 105 cfu/ml Pseudomonas
Well diffusion method
Measurement of the inhibition zone diameter by (mm) around wells containing copper nanoparticles on nutrient agar containing 105 cfu/ml Staphylococcus aureus
disc diffusion method
Measurement of the inhibition zone diameter by (mm) around wells containing copper nanoparticles on nutrient agar containing 105 cfu/ml Pseudomonas
disc diffusion method
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 (+++)
Modified Tissue Culture Plate method (TCP):by ELISA
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 (+++)
Modified Tissue Culture Plate method (TCP):by ELISA
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 (+++)
Modified Tissue Culture Plate method (TCP):by ELISA
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 (+++)
Modified Tissue Culture Plate method (TCP):by ELISA
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).
disc diffusion method
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).
disc diffusion method
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).
disc diffusion method
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).
disc diffusion method

Secondary Outcome Measures

Full Information

First Posted
February 22, 2021
Last Updated
March 2, 2021
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT04775238
Brief Title
Effect of Metallic Nanoparticles on Nosocomial Bacteria
Official Title
Metallic Nanoparticles: Evaluation of Their Antibacterial, Antibiofilm and Synergistic Effect in Combination With Antibiotics on Nosocomial Bacteria
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 27, 2021 (Actual)
Primary Completion Date
June 20, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nosocomial Infections
Keywords
Staphylococcus aureus, Pseudomonas, silver nanoparticles, copper nanoparticles

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Staphylococcus aureus)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2 (Pseudomonas aeruginosa )
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Silver nanoparticles
Other Intervention Name(s)
AgNPs
Intervention Description
AgNPs (19±5 nm)
Intervention Type
Other
Intervention Name(s)
Copper nanoparticles
Other Intervention Name(s)
CuNPs
Intervention Description
CuNPs (150-350 nm)
Primary Outcome Measure Information:
Title
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
Description
Well diffusion method
Time Frame
24 hours
Title
Measurement of the inhibition zone diameter by (mm) around wells containing silver nanoparticles on nutrient agar containing 105 cfu/ml Pseudomonas
Description
Well diffusion method
Time Frame
24 hours
Title
Measurement of the inhibition zone diameter by (mm) around wells containing copper nanoparticles on nutrient agar containing 105 cfu/ml Staphylococcus aureus
Description
disc diffusion method
Time Frame
24 hours
Title
Measurement of the inhibition zone diameter by (mm) around wells containing copper nanoparticles on nutrient agar containing 105 cfu/ml Pseudomonas
Description
disc diffusion method
Time Frame
24 hours
Title
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 (+++)
Description
Modified Tissue Culture Plate method (TCP):by ELISA
Time Frame
24 hours
Title
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 (+++)
Description
Modified Tissue Culture Plate method (TCP):by ELISA
Time Frame
24 hours
Title
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 (+++)
Description
Modified Tissue Culture Plate method (TCP):by ELISA
Time Frame
24 hours
Title
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 (+++)
Description
Modified Tissue Culture Plate method (TCP):by ELISA
Time Frame
24 hours
Title
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).
Description
disc diffusion method
Time Frame
24 hours
Title
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).
Description
disc diffusion method
Time Frame
24 hours
Title
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).
Description
disc diffusion method
Time Frame
24 hours
Title
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).
Description
disc diffusion method
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nahed Fathallah, lecturer
Phone
01142283865
Email
nanafahmy_783@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ekram Abdelrahman, lecturer
Phone
+201004691692
Email
dr.ekram.ar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nahed Fathallah, lecturer
Organizational Affiliation
Sohag University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine - sohag university
City
Sohag
ZIP/Postal Code
82524
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hassan Elnoamany, Professor
Phone
+201002554984
Email
hassan.noaman@med.sohag.edu.eg
First Name & Middle Initial & Last Name & Degree
Mona Fattouh, Professor
Phone
+201009222054
Email
monarahman2002@yahoo.co.uk
First Name & Middle Initial & Last Name & Degree
Ekram Abdelrahman, lecturer

12. IPD Sharing Statement

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Effect of Metallic Nanoparticles on Nosocomial Bacteria

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