Phenotypic and Genotypic Detection of Biofilm Formation a... | NCT07541690

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2026Estimated

Primary Completion Date

Aug 2026Estimated

Completion Date

Feb 2027Estimated

First Submitted Date

Mar 31, 2026

First Submission Date that Met QC Criteria

Apr 16, 2026

First Posted Date

Apr 21, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2026

Last Update Posted Date

Apr 21, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ghofran Mahrous Mohamed, Demonstrator in Microbiology and immunology department, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Sample: urine, pus and sputum samples.
Culture: the samples will be inoculated on the MacConkey agar and subcultured on eosine methylene blue agar.
Identification of isolates will be done by:
- Colony morphology.
- Gram staining.
- Biochemical reactions: including Indole, Methyl red, Voges-Proskauer, and Citrate utilization (IMViC) tests.
Antimicrobial susceptibility testing of the isolates will be performed using the Kirby-Bauer method (disc diffusion method) using Muller Hinton agar according to the Clinical and Laboratory Standards Institute (CLSI 2025) guidelines for selected groups of antibiotics.
Phenotypic detection of biofilm formation by the microtitre plate method.
Phenotypic detection of efflux pump activity by ethidium bromide-agar cartwheel method.
Detection of biofilm genes (fimH-1, mrkA, and mrkD) by conventional PCR.
Detection of efflux pump genes (acrAB, tolC, and mdtk) by conventional PCR.

Detailed Description

K. pneumoniae is a member of the Gram negative Enterobacteriaceae family. It is a rod-shaped, capsulated, non-motile, non-spore-forming bacteria characterized by a unique mucoid look on agar plates.

Klebsiella pneumoniae is an opportunistic pathogen that is responsible for a wide range of community-acquired and healthcare-associated infections including urinary tract infections, wound infection, bacteremia, and pneumonia

Sample: urine, pus and sputum samples.
Culture: the samples will be inoculated on the MacConkey agar and subcultured on eosine methylene blue agar.
Identification of isolates will be done by:
- Colony morphology.
- Gram staining.
- Biochemical reactions: including Indole, Methyl red, Voges-Proskauer, and Citrate utilization (IMViC) tests.
Antimicrobial susceptibility testing of the isolates will be performed using the Kirby-Bauer method (disc diffusion method) using Muller Hinton agar according to the Clinical and Laboratory Standards Institute (CLSI 2025) guidelines for selected groups of antibiotics.
Phenotypic detection of biofilm formation by the microtitre plate method.
Phenotypic detection of efflux pump activity by ethidium bromide-agar cartwheel method.
Detection of biofilm genes (fimH-1, mrkA, and mrkD) by conventional PCR.
Detection of efflux pump genes (acrAB, tolC, and mdtk) by conventional PCR.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: MDR Klebsiella pneumoniae isolates.			Genetic: Genotypic Detection of Biofilm Formation and Efflux Pump Activity.
group 2: Non-MDR Klebsiella pneumoniae isolates.			Genetic: Genotypic Detection of Biofilm Formation and Efflux Pump Activity.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Genotypic Detection of Biofilm Formation and Efflux Pump Activity.	Genetic	Phenotypic detection of biofilm formation by the microtitre plate method. Phenotypic detection of efflux pump activity by ethidium bromide-agar cartwheel method. Detection of biofilm genes (fimH-1, mrkA, and mrkD) by conventional PCR. Detection of efflux pump genes (acrAB, tolC, and mdtk) by conventional PCR.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevelace of biofilm formation genes in MDR Klebsiella pneumonea isolates (%)		6 months

Secondary Outcomes

Measure	Description	Time Frame
Prevelace of efflux pump genes in MDR Klebsiella pneumonea isolates (%)		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:1-Age and sex range: any age and any sex. 2-Clinical setting: hospital-acquired infections. 3-Single pathogen focus. 4-MDR K. pneumoniae which develop resistance to at least one agent from three or more antibiotic classes.

Exclusion Criteria:1-Recent antibiotics : Use within 48-72 hours before enrollment.

2-Mixed infections.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All selected patients to complete history all samples transported to medical microbiology department.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ghofran Mahrous Mohammed	Contact	01154027711		ghofran.azam898@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Description

Biospecimen Description: Bacterial isolates of multidrug resistant Klebsiella pneumoniae from clinical specimens. Genomic DNA will be extracted and stored for molecular detection of efflux pump activity genes and biofilm formation genes.