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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07475429
Enrollment
100
Registered
2026-03-16
Start date
2026-03-15
Completion date
2026-10-01
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbapenem-resistant Hypervirulent Klebsiella Pneumoniae Infection

Brief summary

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 .

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 .

Interventions

DIAGNOSTIC_TESTCefiderocol susceptibility testing

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

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Proportion of cefiderocol-susceptible CR-hvKP isolates (%)6 months

Secondary

MeasureTime frame
Prevalence of siderophore-associated genes among CR-hvKP isolates (%)6 months
Difference in cefiderocol susceptibility rates between siderophore gene-positive and siderophore gene-negative CR-hvKP isolates (%)6 months

Countries

Egypt

Contacts

CONTACTLobna Rashad
lobna.rashad@med.sohag.edu.eg+20 114 7448161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026