Nosocomial InfectionsNCT04775238
Effect of Metallic Nanoparticles on Nosocomial Bacteria
A study testing Silver nanoparticles and Copper nanoparticles in people with Nosocomial Infections, run by Sohag University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nosocomial Infections
- What is being tested?
- Silver nanoparticles and Copper nanoparticles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Feb 2021to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urinary tract infections (UTI)
- Surgical site infections (SSI)
- Catheter related blood stream infection (CRBSI)
- Infected burns
- Chest infection
Who cannot join
- Patients less than 18 years.
- Community acquired infections
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine - sohag university
Sohag, 82524
Hassan Elnoamany, Professor, +201002554984, hassan.noaman@med.sohag.edu.eg
Mona Fattouh, Professor, +201009222054, monarahman2002@yahoo.co.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Nosocomial Infections
- Being tested
- Silver nanoparticles, Copper nanoparticles
- Keywords
- Staphylococcus aureus, Pseudomonas, silver nanoparticles, copper nanoparticles
- Medical subject headings
- Cross Infection, Staphylococcal Infections, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver nanoparticlesOther
Also called AgNPs
AgNPs (19±5 nm)
Copper nanoparticlesOther
Also called CuNPs
CuNPs (150-350 nm)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Silver nanoparticles; Other: 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. Receives: Other: Silver nanoparticles; Other: Copper nanoparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start27 Feb 2021
- Primary completion20 Jun 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nosocomial InfectionsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahed Fathallah Fahmy, Sohag University
- Investigators
- Nahed Fathallah, lecturer, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775238
- Sponsor's protocol ID
- Soh-Med-21-02-21
- Status last verified
- Feb 2021
- First submitted
- 22 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metallic Nanoparticles: Evaluation of Their Antibacterial, Antibiofilm and Synergistic Effect in Combination With Antibiotics on Nosocomial Bacteria
- ClinicalTrials.gov ID
- NCT04775238
- Acronym / sponsor ID
- Soh-Med-21-02-21
- Conditions
- Nosocomial Infections
- Keywords
- Staphylococcus aureus, Pseudomonas, silver nanoparticles, copper nanoparticles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 27 Feb 2021 (actual)
- Primary completion
- 20 Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Staphylococcus aureus) | Active comparator | Other: Silver nanoparticles, Other: Copper nanoparticlesStaphylococcus 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. |
| Group 2 (Pseudomonas aeruginosa ) | Active comparator | Other: Silver nanoparticles, Other: Copper nanoparticlesPseudomonas 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Urinary tract infections (UTI)
- Surgical site infections (SSI)
- Catheter related blood stream infection (CRBSI)
- Infected burns
- Chest infection
Key exclusion criteria (2 listed)
- Patients less than 18 years.
- Community acquired infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver nanoparticlesAlso: AgNPsAgNPs (19±5 nm) | Other | Group 1 (Staphylococcus aureus), Group 2 (Pseudomonas aeruginosa ) |
| Copper nanoparticlesAlso: CuNPsCuNPs (150-350 nm) | Other | Group 1 (Staphylococcus aureus), Group 2 (Pseudomonas aeruginosa ) |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nahed Fathallah, lecturer principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver nanoparticles and Copper nanoparticles in people with Nosocomial Infections, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nahed Fathallah, lecturer (01142283865, nanafahmy_783@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.