Carbapenem-resistant Hypervirulent Klebsiella Pneumoniae InfectionNCT07475429
Impact of Siderophore Genes on Cefiderocol Susceptibility in Carbapenem Resistant Hypervirulent Klebsiella Pneumoniae
An observational study of Carbapenem-resistant Hypervirulent Klebsiella Pneumoniae Infection, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Carbapenem-resistant Hypervirulent Klebsiella Pneumoniae Infection
- What is being tested?
- Cefiderocol susceptibility testing
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2026to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All selected patients subjected to complete history all samples transported to medical microbiology department
Who may be able to join
- 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.
Who cannot join
- Patients who received antibiotic treatment in the 48 hours prior to sample collection.
- 2. Patients with incomplete clinical data or inadequate samples.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
- 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 .
Read the 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
- 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 .
- Being tested
- Cefiderocol susceptibility testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefiderocol susceptibility testingDiagnostic test
Determination of cefiderocol susceptibility in carbapenem-resistant hypervirulent Klebsiella pneumoniae isolates using antimicrobial susceptibility testing according to CLSI guidelines.
| Study group | Role | What they receive |
|---|---|---|
| • 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. Receives: 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. Receives: Diagnostic Test: Cefiderocol susceptibility testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of cefiderocol-susceptible CR-hvKP isolates (%)
Measured: 6 months
Secondary outcomes (2)
Prevalence of siderophore-associated genes among CR-hvKP isolates (%)
Measured: 6 months
Difference in cefiderocol susceptibility rates between siderophore gene-positive and siderophore gene-negative CR-hvKP isolates (%)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbapenem-resistant Hypervirulent Klebsiella Pneumoniae InfectionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lobna Rashad Elsayed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475429
- Sponsor's protocol ID
- Soh-Med--25--12-3MS
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Siderophore Genes on Cefiderocol Susceptibility in Carbapenem Resistant Hypervirulent Klebsiella Pneumoniae
- ClinicalTrials.gov ID
- NCT07475429
- Acronym / sponsor ID
- Soh-Med--25--12-3MS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 .
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
- 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 .
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| • Cefiderocol susceptible CR-hvKP isolates | – | Diagnostic Test: Cefiderocol susceptibility testingClinical 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. |
| Cefiderocol resistant CR-hvKP isolates | – | Diagnostic Test: Cefiderocol susceptibility testingClinical 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All selected patients subjected to complete history all samples transported to medical microbiology department
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who received antibiotic treatment in the 48 hours prior to sample collection.
- 2. Patients with incomplete clinical data or inadequate samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefiderocol susceptibility testingDetermination of cefiderocol susceptibility in carbapenem-resistant hypervirulent Klebsiella pneumoniae isolates using antimicrobial susceptibility testing according to CLSI guidelines. | Diagnostic test | Cefiderocol resistant CR-hvKP isolates, • Cefiderocol susceptible CR-hvKP isolates |
Primary outcome
Proportion of cefiderocol-susceptible CR-hvKP isolates (%)
Time frame: 6 months
2 secondary outcomes
Prevalence of siderophore-associated genes among CR-hvKP isolates (%)
Time frame: 6 months
Difference in cefiderocol susceptibility rates between siderophore gene-positive and siderophore gene-negative CR-hvKP isolates (%)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbapenem-resistant Hypervirulent Klebsiella Pneumoniae Infection, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lobna Rashad (+20 114 7448161, lobna.rashad@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of cefiderocol-susceptible CR-hvKP isolates (%) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.