NCT04775238

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

February 27, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

February 22, 2021

Last Update Submit

March 2, 2021

Conditions

Nosocomial Infections

Keywords

Staphylococcus aureusPseudomonassilver nanoparticlescopper nanoparticles

Outcome Measures

Primary Outcomes (12)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Group 1 (Staphylococcus aureus)

ACTIVE COMPARATOR

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.

Other: Silver nanoparticlesOther: Copper nanoparticles

Group 2 (Pseudomonas aeruginosa )

ACTIVE COMPARATOR

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.

Other: Silver nanoparticlesOther: Copper nanoparticles

Interventions

Silver nanoparticlesOTHER

AgNPs (19±5 nm)

Also known as: AgNPs
Group 1 (Staphylococcus aureus)Group 2 (Pseudomonas aeruginosa )
Copper nanoparticlesOTHER

CuNPs (150-350 nm)

Also known as: CuNPs
Group 1 (Staphylococcus aureus)Group 2 (Pseudomonas aeruginosa )

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Urinary tract infections (UTI)
  • Surgical site infections (SSI)
  • Catheter related blood stream infection (CRBSI)
  • Infected burns
  • Chest infection

You may not qualify if:

  • Patients less than 18 years.
  • Community acquired infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine - sohag university

Sohag, 82524, Egypt

RECRUITING

MeSH Terms

Conditions

Cross InfectionStaphylococcal InfectionsPseudomonas Infections

Interventions

colloidal silver

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesGram-Negative Bacterial Infections

Study Officials

  • Nahed Fathallah, lecturer

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nahed Fathallah, lecturer

CONTACT

01142283865nanafahmy_783@yahoo.com

Ekram Abdelrahman, lecturer

CONTACT

+201004691692dr.ekram.ar@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of medical microbiology & immunology departement -faculty of medicine- sohag university

Study Record Dates

First Submitted

February 22, 2021

First Posted

March 1, 2021

Study Start

February 27, 2021

Primary Completion

June 20, 2021

Study Completion

July 1, 2021

Last Updated

March 3, 2021

Record last verified: 2021-02

Locations

EG(1)