NCT06628076

Brief 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. These infections are usually associated with high mortality rates ranging between 26% among hospitalized patients and 43% among ICU patients.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

September 26, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

Same day

First QC Date

September 26, 2024

Last Update Submit

October 3, 2024

Conditions

Keywords

A. baumannii.BiofilmZnO NPshospital aquired infections

Outcome Measures

Primary Outcomes (5)

  • A. baumannii antibiotic susceptibility profile

    A. baumannii antibiotic susceptibility profile will be done using modified kirbybeur method

    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

    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

    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

    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)

    October 2024 to December 2025

Interventions

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

Detection of the effect of ZnO NPs on the biofilm producer MDR A. baumannii strains using the same method

\- 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.

Eligibility Criteria

AgeUp to 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will be carried out at Department of Medical Microbiology and Immunology, Sohag Faculty of Medicine and Sohag University Hospitals.

You may qualify if:

  • All patients suffering from infections that can be caused by A. baumannii.

You may not qualify if:

  • All patients suffering from infections that aren\'t caused by A. baumannii.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university, Faculty of medicine

Sohag, 534568, Egypt

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Different samples (pus, urine, urinary catheter samples, wound swabs, sputum, bronchoalveolar lavage and central venous catheter samples) will be collected under strict aseptic precautions from patients admitted at different departments at Sohag university hospitals

MeSH Terms

Conditions

Cross InfectionRespiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract Diseases

Central Study Contacts

Shimaa Anwar Ahmed, Assistant Lecturer

CONTACT

Noha Saber Shafik, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of Medical Microbiology and Immunology

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 4, 2024

Study Start

October 10, 2024

Primary Completion

October 10, 2024

Study Completion

December 30, 2025

Last Updated

October 4, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations