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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04775238
Other study ID # Soh-Med-21-02-21
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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