Effect of Metallic Nanoparticles on Nosocomial Bacteria

Nosocomial Infections Clinical Trial

Official title:

Metallic Nanoparticles: Evaluation of Their Antibacterial, Antibiofilm and Synergistic Effect in Combination With Antibiotics on Nosocomial Bacteria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04775238
• Other study ID #: Soh-Med-21-02-21
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: February 2021
• Source: Sohag University
• Contact: Nahed Fathallah, lecturer
• Phone: 01142283865
• Email: nanafahmy_783[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2021
• Est. primary completion date: June 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cross Infection
• Nosocomial Infections

Intervention

Other:
• Silver nanoparticles
AgNPs (19±5 nm)
• Copper nanoparticles
CuNPs (150-350 nm)

Locations

Country	Name	City	State
Egypt	Faculty of medicine - sohag university	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours
Primary	Measurement of the inhibition zone diameter by (mm) around wells containing silver nanoparticles on nutrient agar containing 105 cfu/ml Pseudomonas	Well diffusion method	24 hours
Primary	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	24 hours
Primary	Measurement of the inhibition zone diameter by (mm) around wells containing copper nanoparticles on nutrient agar containing 105 cfu/ml Pseudomonas	disc diffusion method	24 hours
Primary	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	24 hours
Primary	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	24 hours
Primary	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	24 hours
Primary	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	24 hours
Primary	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	24 hours
Primary	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	24 hours
Primary	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	24 hours
Primary	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	24 hours