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NCT Number: NCT07475429

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

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 .

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine

Sohag, Egypt

About this study

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

  • Sample: Clinical specimens (blood, urine, sputum, wound swabs) will be collected aseptically and transported to the microbiology laboratory for analysis.
  • 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
  • Identification of isolates will be done by:

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

  • 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)."

  • MIC determination for cifederecol using E-test .
  • Phenotypic Detection of hvKP:
  • String Test: A viscous string ≥5 mm formed by stretching a single colony indicates hypermucoviscosity .
  • Capsule Staining: to visualize large capsules .
  • Siderophore Production: Assessed on chrome azurol S (CAS) agar to detect iron-chelating activity.
  • Detection of siderophore genes by Simple qualitative PCR .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Patients who received antibiotic treatment in the 48 hours prior to sample collection.
  • Patients with incomplete clinical data or inadequate samples.

Treatment and study plan

Cefiderocol susceptibility testing

Diagnostic Test

Determination of cefiderocol susceptibility in carbapenem-resistant hypervirulent Klebsiella pneumoniae isolates using antimicrobial susceptibility testing according to CLSI guidelines.

Primary outcomes

  1. Proportion of cefiderocol-susceptible CR-hvKP isolates (%)

    Time frame: 6 months

Secondary outcomes

  1. Prevalence of siderophore-associated genes among CR-hvKP isolates (%)

    Time frame: 6 months

  2. Difference in cefiderocol susceptibility rates between siderophore gene-positive and siderophore gene-negative CR-hvKP isolates (%)

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Lobna Rashad

CONTACT

[email protected]

+20 114 7448161

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.