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

NCT07475429 | Not Yet Recruiting

• 1 other identifier: Soh-Med--25--12-3MS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Sample: Clinical specimens (blood, urine, sputum, wound swabs) will be collected aseptically and transported to the microbiology laboratory for analysis.
2. 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. 3.Identification of isolates will be done by:
4. 4.Antimicrobial susceptibility testing of the isolates :
5. 5.MIC determination for cifederecol using E-test .
6. 6.Phenotypic Detection of hvKP:
7. 7.String Test: A viscous string ≥5 mm formed by stretching a single colony indicates hypermucoviscosity .
8. 8.Capsule Staining: to visualize large capsules .
9. 9.Siderophore Production: Assessed on chrome azurol S (CAS) agar to detect iron-chelating activity.
10. 10.Detection of siderophore genes by Simple qualitative PCR .

Conditions

Carbapenem-resistant Hypervirulent Klebsiella Pneumoniae Infection

Outcome Measures

Primary Outcomes (1)

• Proportion of cefiderocol-susceptible CR-hvKP isolates (%)

  6 months

Secondary Outcomes (2)

• 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

Study Arms (2)

• 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

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

Interventions

Cefiderocol susceptibility testing DIAGNOSTIC_TEST

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

Cefiderocol resistant CR-hvKP isolates; • Cefiderocol susceptible CR-hvKP isolates

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of Medicine

Sohag, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial isolates of carbapenem-resistant hypervirulent Klebsiella pneumoniae from clinical specimens. Genomic DNA will be extracted and stored for molecular detection of siderophore and virulence genes.

Central Study Contacts

Lobna Rashad

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator of microbiology

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 16, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)