Impact of Siderophore Genes on Cefiderocol Susceptibility in Carbapenem Resistant Hypervirulent Klebsiella Pneumoniae

March 19, 2026 updated by: Lobna Rashad Elsayed, Sohag University
  1. Sample: Clinical specimens (blood, urine, sputum, wound swabs) will be collected aseptically and transported to the microbiology laboratory for analysis.
  2. Culture: Specimens will be inoculated on MacConkey agar and incubated at 35-37°C for 18-24 hours. Colonies with typical K. pneumoniae morphology (mucoid, lactose-fermenting) will be selected for further testing

  3. Identification of isolates will be done by:

    Colony morphology, Gram staining, and conventional biochemical tests (eg, indole, citrate utilization, urease, Voges-Proskauer) .

  4. Antimicrobial susceptibility testing of the isolates :

    Antimicrobial susceptibility testing was performed and interpreted according to the Clinical and Laboratory Standards Institute (CLSI) guidelines, M100 document (latest edition)."

  5. MIC determination for cifederecol using E-test .

  6. Phenotypic Detection of hvKP:

    1. String Test: A viscous string ≥5 mm formed by stretching a single colony indicates hypermucoviscosity .
    2. Capsule Staining: to visualize large capsules .
    3. Siderophore Production: Assessed on chrome azurol S (CAS) agar to detect iron-chelating activity.
  7. Detection of siderophore genes by Simple qualitative PCR .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Klebsiella pneumoniae ( K.pneumoniae ) is a Gram-negative, encapsulated, non-motile bacterium of the Enterobacteriaceae family and a major pathogen responsible for a broad spectrum of healthcare- and community-acquired infections, including pneumonia, urinary tract infections, bloodstream infections, and pyogenic liver abscesses

  1. Sample: Clinical specimens (blood, urine, sputum, wound swabs) will be collected aseptically and transported to the microbiology laboratory for analysis.
  2. Culture: Specimens will be inoculated on MacConkey agar and incubated at 35-37°C for 18-24 hours. Colonies with typical K. pneumoniae morphology (mucoid, lactose-fermenting) will be selected for further testing

  3. Identification of isolates will be done by:

    Colony morphology, Gram staining, and conventional biochemical tests (eg, indole, citrate utilization, urease, Voges-Proskauer) .

  4. Antimicrobial susceptibility testing of the isolates :

    Antimicrobial susceptibility testing was performed and interpreted according to the Clinical and Laboratory Standards Institute (CLSI) guidelines, M100 document (latest edition)."

  5. MIC determination for cifederecol using E-test .

  6. Phenotypic Detection of hvKP:

    1. String Test: A viscous string ≥5 mm formed by stretching a single colony indicates hypermucoviscosity .
    2. Capsule Staining: to visualize large capsules .
    3. Siderophore Production: Assessed on chrome azurol S (CAS) agar to detect iron-chelating activity.
  7. Detection of siderophore genes by Simple qualitative PCR .

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt
        • Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

- 1. Patients with hypervirulant K. pneumoniae infection from various clinical specimens (blood, urine, sputum, wound swabs, etc.) Confirmed by culture and initial laboratory testing .

2. Age and sex range: any age and any sex.

Exclusion Criteria:

- Patients who received antibiotic treatment in the 48 hours prior to sample collection.

2. Patients with incomplete clinical data or inadequate samples.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
• Cefiderocol susceptible CR-hvKP isolates
Clinical carbapenem-resistant hypervirulent Klebsiella pneumoniae isolates that test positive for siderophore genes. These isolates will be evaluated for susceptibility to cefiderocol using standard antimicrobial susceptibility testing methods.
Diagnostic test: Cefiderocol susceptibility testing
Determination of cefiderocol susceptibility in carbapenem-resistant hypervirulent Klebsiella pneumoniae isolates using antimicrobial susceptibility testing according to CLSI guidelines.
Cefiderocol resistant CR-hvKP isolates
Clinical isolates of carbapenem-resistant hypervirulent Klebsiella pneumoniae collected from clinical samples. Isolates will be tested for the presence of siderophore genes and their susceptibility to cefiderocol using standard antimicrobial susceptibility testing methods.
Diagnostic test: Cefiderocol susceptibility testing
Determination of cefiderocol susceptibility in carbapenem-resistant hypervirulent Klebsiella pneumoniae isolates using antimicrobial susceptibility testing according to CLSI guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of cefiderocol-susceptible CR-hvKP isolates (%)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of siderophore-associated genes among CR-hvKP isolates (%)
Time Frame: 6 months
6 months
Difference in cefiderocol susceptibility rates between siderophore gene-positive and siderophore gene-negative CR-hvKP isolates (%)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Soh-Med--25--12-3MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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