Multidrug Resistant Klebsiella Pneumoniae InfectionKlebsiellaNCT07541690
Phenotypic and Genotypic Detection of Biofilm Formation and Efflux Pump Activity in Multi-drug Resistant Klebsiella Pneumoniae
An observational study of Multidrug Resistant Klebsiella Pneumoniae Infection, run by Sohag University.
Trial summary
1. Sample: urine, pus and sputum samples. 2. Culture: the samples will be inoculated on the MacConkey agar and subcultured on eosine methylene blue agar. 3. Identification of isolates will be done by: Colony morphology. Gram staining. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Multidrug Resistant Klebsiella Pneumoniae Infection
- What is being tested?
- Genotypic Detection of Biofilm Formation and Efflux Pump Activity.
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Feb 2027
- 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 to complete history all samples transported to medical microbiology department.
Inclusion Criteria:1-Age and sex range: any age and any sex. 2-Clinical setting: hospital-acquired infections. 3-Single pathogen focus. 4-MDR K. pneumoniae which develop resistance to at least one agent from three or more antibiotic classes.
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Exclusion Criteria:1-Recent antibiotics : Use within 48-72 hours before enrollment.
2-Mixed infections.
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Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- Sample: urine, pus and sputum samples.
- Culture: the samples will be inoculated on the MacConkey agar and subcultured on eosine methylene blue agar.
- Identification of isolates will be done by:
- Colony morphology.
- Gram staining.
- Biochemical reactions: including Indole, Methyl red, Voges-Proskauer, and Citrate utilization (IMViC) tests.
- Antimicrobial susceptibility testing of the isolates will be performed using the Kirby-Bauer method (disc diffusion method) using Muller Hinton agar according to the Clinical and Laboratory Standards Institute (CLSI 2025) guidelines for selected groups of antibiotics.
- Phenotypic detection of biofilm formation by the microtitre plate method.
- Phenotypic detection of efflux pump activity by ethidium bromide-agar cartwheel method.
- Detection of biofilm genes (fimH-1, mrkA, and mrkD) by conventional PCR.
- Detection of efflux pump genes (acrAB, tolC, and mdtk) by conventional PCR.
Read the detailed description
- pneumoniae is a member of the Gram negative Enterobacteriaceae family. It is a rod-shaped, capsulated, non-motile, non-spore-forming bacteria characterized by a unique mucoid look on agar plates.
Klebsiella pneumoniae is an opportunistic pathogen that is responsible for a wide range of community-acquired and healthcare-associated infections including urinary tract infections, wound infection, bacteremia, and pneumonia
- Sample: urine, pus and sputum samples.
- Culture: the samples will be inoculated on the MacConkey agar and subcultured on eosine methylene blue agar.
- Identification of isolates will be done by:
- Colony morphology.
- Gram staining.
- Biochemical reactions: including Indole, Methyl red, Voges-Proskauer, and Citrate utilization (IMViC) tests.
- Antimicrobial susceptibility testing of the isolates will be performed using the Kirby-Bauer method (disc diffusion method) using Muller Hinton agar according to the Clinical and Laboratory Standards Institute (CLSI 2025) guidelines for selected groups of antibiotics.
- Phenotypic detection of biofilm formation by the microtitre plate method.
- Phenotypic detection of efflux pump activity by ethidium bromide-agar cartwheel method.
- Detection of biofilm genes (fimH-1, mrkA, and mrkD) by conventional PCR.
- Detection of efflux pump genes (acrAB, tolC, and mdtk) by conventional PCR.
- Being tested
- Genotypic Detection of Biofilm Formation and Efflux Pump Activity.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genotypic Detection of Biofilm Formation and Efflux Pump Activity.Genetic
- Phenotypic detection of biofilm formation by the microtitre plate method.
- Phenotypic detection of efflux pump activity by ethidium bromide-agar cartwheel method.
- Detection of biofilm genes (fimH-1, mrkA, and mrkD) by conventional PCR.
- Detection of efflux pump genes (acrAB, tolC, and mdtk) by conventional PCR.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: MDR Klebsiella pneumoniae isolates. | Not described Receives: Genetic: Genotypic Detection of Biofilm Formation and Efflux Pump Activity. | |
| group 2: Non-MDR Klebsiella pneumoniae isolates. | Not described Receives: Genetic: Genotypic Detection of Biofilm Formation and Efflux Pump Activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevelace of biofilm formation genes in MDR Klebsiella pneumonea isolates (%)
Measured: 6 months
Secondary outcomes (1)
Prevelace of efflux pump genes in MDR Klebsiella pneumonea 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 posted21 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multidrug Resistant 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 only
- 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, Ghofran Mahrous Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541690
- Sponsor's protocol ID
- Soh-Med--25-12-4MS
- Acronym
- Klebsiella
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic and Genotypic Detection of Biofilm Formation and Efflux Pump Activity in Multi-drug Resistant Klebsiella Pneumoniae
- ClinicalTrials.gov ID
- NCT07541690
- Acronym / sponsor ID
- Klebsiella / Soh-Med--25-12-4MS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 21 Apr 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: urine, pus and sputum samples.
- Culture: the samples will be inoculated on the MacConkey agar and subcultured on eosine methylene blue agar.
- Identification of isolates will be done by:
- Colony morphology.
- Gram staining.
- Biochemical reactions: including Indole, Methyl red, Voges-Proskauer, and Citrate utilization (IMViC) tests.
- Antimicrobial susceptibility testing of the isolates will be performed using the Kirby-Bauer method (disc diffusion method) using Muller Hinton agar according to the Clinical and Laboratory Standards Institute (CLSI 2025) guidelines for selected groups of antibiotics.
- Phenotypic detection of biofilm formation by the microtitre plate method.
- Phenotypic detection of efflux pump activity by ethidium bromide-agar cartwheel method.
- Detection of biofilm genes (fimH-1, mrkA, and mrkD) by conventional PCR.
- Detection of efflux pump genes (acrAB, tolC, and mdtk) by conventional PCR.
Detailed description
- pneumoniae is a member of the Gram negative Enterobacteriaceae family. It is a rod-shaped, capsulated, non-motile, non-spore-forming bacteria characterized by a unique mucoid look on agar plates.
Klebsiella pneumoniae is an opportunistic pathogen that is responsible for a wide range of community-acquired and healthcare-associated infections including urinary tract infections, wound infection, bacteremia, and pneumonia
- Sample: urine, pus and sputum samples.
- Culture: the samples will be inoculated on the MacConkey agar and subcultured on eosine methylene blue agar.
- Identification of isolates will be done by:
- Colony morphology.
- Gram staining.
- Biochemical reactions: including Indole, Methyl red, Voges-Proskauer, and Citrate utilization (IMViC) tests.
- Antimicrobial susceptibility testing of the isolates will be performed using the Kirby-Bauer method (disc diffusion method) using Muller Hinton agar according to the Clinical and Laboratory Standards Institute (CLSI 2025) guidelines for selected groups of antibiotics.
- Phenotypic detection of biofilm formation by the microtitre plate method.
- Phenotypic detection of efflux pump activity by ethidium bromide-agar cartwheel method.
- Detection of biofilm genes (fimH-1, mrkA, and mrkD) by conventional PCR.
- Detection of efflux pump genes (acrAB, tolC, and mdtk) by conventional PCR.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: MDR Klebsiella pneumoniae isolates. | – | Genetic: Genotypic Detection of Biofilm Formation and Efflux Pump Activity. |
| group 2: Non-MDR Klebsiella pneumoniae isolates. | – | Genetic: Genotypic Detection of Biofilm Formation and Efflux Pump Activity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All selected patients to complete history all samples transported to medical microbiology department.
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 |
|---|---|---|
| Genotypic Detection of Biofilm Formation and Efflux Pump Activity.1. Phenotypic detection of biofilm formation by the microtitre plate method. 2. Phenotypic detection of efflux pump activity by ethidium bromide-agar cartwheel method. 3. Detection of biofilm genes (fimH-1, mrkA, and mrkD) by conventional PCR. 4. Detection of efflux pump genes (acrAB, tolC, and mdtk) by conventional PCR. | Genetic | Group 1: MDR Klebsiella pneumoniae isolates., group 2: Non-MDR Klebsiella pneumoniae isolates. |
Primary outcome
Prevelace of biofilm formation genes in MDR Klebsiella pneumonea isolates (%)
Time frame: 6 months
1 secondary outcome
Prevelace of efflux pump genes in MDR Klebsiella pneumonea 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 21 Apr 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Multidrug Resistant Klebsiella Pneumoniae Infection, run by Sohag University.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ghofran Mahrous Mohammed (01154027711, ghofran.azam898@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevelace of biofilm formation genes in MDR Klebsiella pneumonea 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 21 Apr 2026.