Infections, NosocomialNCT06628076
Antibacterial Effect of Zinc Oxide Nanoparticles on Acinetobacter Baumannii Isolated From Patients With Hospital Acquired Infections in Sohag University Hospitals, Egypt
An observational study of Infections, Nosocomial and Infections, Respiratory Tract, run by Sohag University at 1 site in Egypt.
Trial summary
A. baumannii is known as the most frequently isolated organism in intensive care units (ICUs), causing a variety of nosocomial infections, including pneumonia, urinary tract infections (UTIs), bacteremia as well as skin and soft tissue infections. Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Infections, Nosocomial, Infections, Respiratory Tract
- What is being tested?
- Culture specific antibiotic therapy, Antibiotic and Biofilm assessment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2024to 30 Dec 2025
- Phase
- Observational
- 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 Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will be carried out at Department of Medical Microbiology and Immunology, Sohag Faculty of Medicine and Sohag University Hospitals.
Who may be able to join
- All patients suffering from infections that can be caused by A. baumannii.
Who cannot join
- All patients suffering from infections that aren\'t caused by A. baumannii.
Trial locations and contacts
1 site in 1 country.
About this study
- baumannii is known as the most frequently isolated organism in intensive care units (ICUs), causing a variety of nosocomial infections, including pneumonia, urinary tract infections (UTIs), bacteremia as well as skin and soft tissue infections. These infections are usually associated with high mortality rates ranging between 26% among hospitalized patients and 43% among ICU patients.
Read the detailed description
Acinetobacter baumannii (A. baumannii) is Gram- negative, aerobic, glucose non-fermentative, non-motile coccobacillus, ubiquitous in nature, and persistent in healthcare settings. It is regarded as a significant opportunistic human pathogen.
This bacterium become a growing problem in hospitals as a predominant multidrug-resistant (MDR) bacterium. Horizontal acquisition of resistance genes is the main factor involved in the emergence of MDR .
There are many mechanisms to confer resistance to different classes of antibiotics in A. baumannii, one of them is multidrug efflux pumps. These efflux pumps are important source of MDR, which export antibiotics from the cell, increasing their antibiotic resistance.
AdeABC is one of the most important efflux systems, belonging to the RND family in Acinetobacter, which plays an important role in the resistance to a broad group of antibiotics; its genes are chromosomal and encode three genes, i.e., AdeB, AdeA, and AdeC, forming an operon in the vicinity. In addition, the expression of AdeABC is done by a two-component system, which includes a response regulator (AdeR) and a sensor kinase (AdeS) .
The ability of Acinetobacter spp. to form biofilm that enables bacterial survival in hospital settings, especially in ICUs, is the most significant contributing factor to their virulence, and this trait is also responsible for their notable antibiotic resistance. Several biofilm-related genes influence antimicrobial susceptibility, suggesting an association between the biofilm-forming ability of Acinetobacter spp. and their antibiotic resistance patterns (MDR/XDR)
Zinc oxide nanoparticles (ZnO NPs) are one of the most important nanoparticles of metal oxides; it is a unique and inorganic materials that can be used in several biological applications (anti-bacterial, anti-inflammatory). ZnO NPs exhibit distinctive properties other than other nanoparticles such as higher solubility, better biofilm penetration and effective drug delivery . ZnO NPs have been reported to have antimicrobial properties such as disrupting the cell membrane of pathogens, accumulating in the cell and producing toxic H2O2 (hydrogen peroxide)
- Being tested
- Culture specific antibiotic therapy, Antibiotic, Biofilm assessment, nanoparticle zinc oxide, Molecular detection of antibiotic resistance
- Keywords
- A. baumannii., Biofilm, ZnO NPs, hospital aquired infections
- Medical subject headings
- Cross Infection, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culture specific antibiotic therapyDiagnostic test
Samples will be cultured on MacConkey agar. Morphological identifications of growth isolates by Gram staining, colony features and conventional biochemical tests. All isolates will be identified to species level using automated bacterial identification systems.
AntibioticDiagnostic test
Strains confirmed as A. baumannii will be examined for their different antibiotic susceptibility by modified Kirby Bauer\'s disc diffusion method on Mueller Hinton Agar.
Biofilm assessmentDiagnostic test
The biofilm formation activity of A. baumannii isolates will be tested using the microtitre plate technique
nanoparticle zinc oxideDiagnostic test
Detection of the effect of ZnO NPs on the biofilm producer MDR A. baumannii strains using the same method
Molecular detection of antibiotic resistanceDiagnostic test
- Evaluation the effect of ZnO NPs on the expression of some efflux pump genes, and biofilm related genes in MDR A. baumannii isolates using Real time PCR technology.
What is being measured
The primary outcome is the main question the study is designed to answer.
A. baumannii antibiotic susceptibility profile
- baumannii antibiotic susceptibility profile will be done using modified kirbybeur method
Measured: October 2024 to December 2025
Isolation and identification of A. baumannii from different clinical samples
Isolation and identification of A. baumannii from different clinical samples using MacConKey medium, oxidase test. TSI, And automated identification ViteK system
Measured: October 2024 to December 2025
A. baumannii strains which produce biofilm
Detection of A. baumannii strains which produce biofilm using tissue culture plates and Gram stain
Measured: October 2024 to December 2025
Ability of ZnO NPs to inhibit the phenomenon of biofilm formation by MDR A. baumannii strains
Assessment of ability of ZnO NPs to inhibit the phenomenon of biofilm formation by MDR A. baumannii strains using ZnO NPs to be applied by different concentrations on tissue culture plates and measure the degree of Biofilm formation using ELISA
Measured: October 2024 to December 2025
The effect of ZnO NPs on the expression of some efflux pump genes and biofilm related genes in MDR A. baumannii strains
Evaluation the effect of ZnO NPs on the expression of some efflux pump genes and biofilm related genes in MDR A. baumannii strains using real time PCR(Polymerase Chain reaction)
Measured: October 2024 to December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start10 Oct 2024
- Primary completion10 Oct 2024
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, NosocomialStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Anwar Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628076
- Sponsor's protocol ID
- Soh-Med-24-9-1MD
- Status last verified
- Aug 2026
- First submitted
- 26 Sep 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibacterial Effect of Zinc Oxide Nanoparticles on Acinetobacter Baumannii Isolated From Patients With Hospital Acquired Infections in Sohag University Hospitals, Egypt
- ClinicalTrials.gov ID
- NCT06628076
- Acronym / sponsor ID
- Soh-Med-24-9-1MD
- Keywords
- A. baumannii., Biofilm, ZnO NPs, hospital aquired infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 4 Oct 2024 (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.
- baumannii is known as the most frequently isolated organism in intensive care units (ICUs), causing a variety of nosocomial infections, including pneumonia, urinary tract infections (UTIs), bacteremia as well as skin and soft tissue infections. These infections are usually associated with high mortality rates ranging between 26% among hospitalized patients and 43% among ICU patients.
Detailed description
Acinetobacter baumannii (A. baumannii) is Gram- negative, aerobic, glucose non-fermentative, non-motile coccobacillus, ubiquitous in nature, and persistent in healthcare settings. It is regarded as a significant opportunistic human pathogen.
This bacterium become a growing problem in hospitals as a predominant multidrug-resistant (MDR) bacterium. Horizontal acquisition of resistance genes is the main factor involved in the emergence of MDR .
There are many mechanisms to confer resistance to different classes of antibiotics in A. baumannii, one of them is multidrug efflux pumps. These efflux pumps are important source of MDR, which export antibiotics from the cell, increasing their antibiotic resistance.
AdeABC is one of the most important efflux systems, belonging to the RND family in Acinetobacter, which plays an important role in the resistance to a broad group of antibiotics; its genes are chromosomal and encode three genes, i.e., AdeB, AdeA, and AdeC, forming an operon in the vicinity. In addition, the expression of AdeABC is done by a two-component system, which includes a response regulator (AdeR) and a sensor kinase (AdeS) .
The ability of Acinetobacter spp. to form biofilm that enables bacterial survival in hospital settings, especially in ICUs, is the most significant contributing factor to their virulence, and this trait is also responsible for their notable antibiotic resistance. Several biofilm-related genes influence antimicrobial susceptibility, suggesting an association between the biofilm-forming ability of Acinetobacter spp. and their antibiotic resistance patterns (MDR/XDR)
Zinc oxide nanoparticles (ZnO NPs) are one of the most important nanoparticles of metal oxides; it is a unique and inorganic materials that can be used in several biological applications (anti-bacterial, anti-inflammatory). ZnO NPs exhibit distinctive properties other than other nanoparticles such as higher solubility, better biofilm penetration and effective drug delivery . ZnO NPs have been reported to have antimicrobial properties such as disrupting the cell membrane of pathogens, accumulating in the cell and producing toxic H2O2 (hydrogen peroxide)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will be carried out at Department of Medical Microbiology and Immunology, Sohag Faculty of Medicine and Sohag University Hospitals.
Key inclusion criteria (1 listed)
- All patients suffering from infections that can be caused by A. baumannii.
Key exclusion criteria (1 listed)
- All patients suffering from infections that aren\'t caused by A. baumannii.
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 |
|---|---|---|
| Culture specific antibiotic therapySamples will be cultured on MacConkey agar. Morphological identifications of growth isolates by Gram staining, colony features and conventional biochemical tests. All isolates will be identified to species level using automated bacterial identification systems. | Diagnostic test | – |
| AntibioticStrains confirmed as A. baumannii will be examined for their different antibiotic susceptibility by modified Kirby Bauer\'s disc diffusion method on Mueller Hinton Agar. | Diagnostic test | – |
| Biofilm assessmentThe biofilm formation activity of A. baumannii isolates will be tested using the microtitre plate technique | Diagnostic test | – |
| nanoparticle zinc oxideDetection of the effect of ZnO NPs on the biofilm producer MDR A. baumannii strains using the same method | Diagnostic test | – |
| Molecular detection of antibiotic resistance- Evaluation the effect of ZnO NPs on the expression of some efflux pump genes, and biofilm related genes in MDR A. baumannii isolates using Real time PCR technology. | Diagnostic test | – |
Primary outcome
A. baumannii antibiotic susceptibility profile
Time frame: October 2024 to December 2025
A. baumannii antibiotic susceptibility profile will be done using modified kirbybeur method
Isolation and identification of A. baumannii from different clinical samples
Time frame: October 2024 to December 2025
Isolation and identification of A. baumannii from different clinical samples using MacConKey medium, oxidase test. TSI, And automated identification ViteK system
A. baumannii strains which produce biofilm
Time frame: October 2024 to December 2025
Detection of A. baumannii strains which produce biofilm using tissue culture plates and Gram stain
Ability of ZnO NPs to inhibit the phenomenon of biofilm formation by MDR A. baumannii strains
Time frame: October 2024 to December 2025
Assessment of ability of ZnO NPs to inhibit the phenomenon of biofilm formation by MDR A. baumannii strains using ZnO NPs to be applied by different concentrations on tissue culture plates and measure the degree of Biofilm formation using ELISA
The effect of ZnO NPs on the expression of some efflux pump genes and biofilm related genes in MDR A. baumannii strains
Time frame: October 2024 to December 2025
Evaluation the effect of ZnO NPs on the expression of some efflux pump genes and biofilm related genes in MDR A. baumannii strains using real time PCR(Polymerase Chain reaction)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Nosocomial and Infections, Respiratory Tract, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A. baumannii antibiotic susceptibility profile (time frame: October 2024 to December 2025). The study lists 5 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 13 Aug 2026.