Clinical Trial

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

Not Yet Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated March 24, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.
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 .
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-10.
Trial Details
NCT Number NCT07475429
Lead Sponsor Sohag University
Conditions Carbapenem-resistant Hypervirulent Klebsiella Pneumoniae Infection
Enrollment 100 participants
Start Date 2026-03-15
Primary Completion 2026-08-01 (estimated)
Study Completion 2026-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-24