ISOLATION OF KLEB. by Culture on macConkey AgarNCT07369518
Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae
An observational study of ISOLATION OF KLEB. by Culture on macConkey Agar and Antibiotic Sensitivity Testing of Different Antibiotics According to Clsi 25, run by Sohag University at 1 site in Egypt.
Trial summary
Specimen Collection : Clinical specimens included blood, urine, bronchoalveolar lavage fluid, wound, peritoneal fluid, and tracheal aspirate obtained from patients with suspected bacterial infections collected in dry sterile well-closed plastic cups. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- ISOLATION OF KLEB. by Culture on macConkey Agar, Antibiotic Sensitivity Testing of Different Antibiotics According to Clsi 25, Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae
- What is being tested?
- . - Genotypic detection of carbapenemase genes by conventional PCR.
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2026to Dec 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
None listed.
Who cannot join
- Infections caused by any organisms other than klebsiella pneumoniae and carbapenem resistant klebsiella pneumoniae by mechanism other than carbapenemases production.
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
Official title: Effect of Ceftazidime-Avibactam Against Carbapenemase-Positive Klebsiella Pneumoniae Causing Health Care-Associated Infections
Specimen Collection : Clinical specimens included blood, urine, bronchoalveolar lavage fluid, wound, peritoneal fluid, and tracheal aspirate obtained from patients with suspected bacterial infections collected in dry sterile well-closed plastic cups.
Bacterial identification by Gram stain, culture and biochemical rections
- analysisThe resistance pattern of the isolates will be detected by disc diffusion method.
- phenotypic detection of carbapenemases. • Detection of carbapenem resistance genes (KPC, VIM, IMP, OXA-48, NDM) by conventional PCR.
Read the detailed description
Carbapenem-resistant Enterobacterales (CRE) poses an urgent global public health threat, with more than 1,100 documented deaths, as reported in a 2019 antibiotic resistance publication by the U.S. Centers for Disease Control and Prevention.
Carbapenem-resistant Enterobacterales, including carbapenem-resistant Klebsiella pneumoniae (CRKP), is associated with higher mortality compared with infections caused by carbapenem-susceptible Enterobacterales infections Specimen Collection : Clinical specimens included blood, urine, bronchoalveolar lavage fluid, wound, peritoneal fluid, and tracheal aspirate obtained from patients with suspected bacterial infections collected in dry sterile well-closed plastic cups.
Bacterial identification by Gram stain, culture and biochemical rections
- analysisThe resistance pattern of the isolates will be detected by disc diffusion method.
- phenotypic detection of carbapenemases. • Detection of carbapenem resistance genes (KPC, VIM, IMP, OXA-48, NDM) by conventional PCR.
- Conditions
- ISOLATION OF KLEB. by Culture on macConkey Agar, Antibiotic Sensitivity Testing of Different Antibiotics According to Clsi 25, Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae, Detection of Resistance Gene in Isolates Using Conventional Pcr, Detection of Some Virulence Genes Using Conventional Pcr
- Being tested
- . - Genotypic detection of carbapenemase genes by conventional PCR.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
. - Genotypic detection of carbapenemase genes by conventional PCR.Genetic
Specimen Collection : Clinical specimens included blood, urine, bronchoalveolar lavage fluid, wound, peritoneal fluid, and tracheal aspirate obtained from patients with suspected bacterial infections collected in dry sterile well-closed plastic cups. Bacterial identification by Gram stain, culture and biochemical rections - analysisThe resistance pattern of the isolates will be detected by disc diffusion method. - phenotypic detection of carbapenemases. • Detection of carbapenem resistance genes (KPC, VIM, IMP, OXA-48, NDM) by conventional PCR.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 patients with klebsiella pneumoniae infection | Infections caused by klebsiella pneumoniae like skin infections, chest infections, surgical site infections, and urinary tract Infections. Receives: Genetic: . - Genotypic detection of carbapenemase genes by conventional PCR. | |
| Group 2 patients without klebsiella pneumoniae | Infections caused by any organisms other than klebsiella pneumoniae and carbapenem resistant klebsiella pneumoniae by mechanism other than carbapenemases production. Receives: Genetic: . - Genotypic detection of carbapenemase genes by conventional PCR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 ISOLATION OF KLEB. by culture on macConkey agar
Measured: 6 months from January to may
Antibiotic sensitivity testing of different antibiotics according to clsi 25
Measured: 6 months from January to may
Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae
Measured: 6 months from January to may
Detection of resistance gene in isolates using conventional pcr
Measured: 6 months from June to December
Detection of some virulence genes using conventional pcr
Measured: 6 months from June to December
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ISOLATION OF KLEB. by Culture on macConkey AgarStudies 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, Walaa ismail Marzouk, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369518
- Sponsor's protocol ID
- Soh-Med-25-12-2MS
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2026
- Last updated
- 27 Jan 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ceftazidime-Avibactam Against Carbapenemase-Positive Klebsiella Pneumoniae Causing Health Care-Associated Infections
- ClinicalTrials.gov ID
- NCT07369518
- Acronym / sponsor ID
- Soh-Med-25-12-2MS
- Conditions
- ISOLATION OF KLEB. by Culture on macConkey Agar, Antibiotic Sensitivity Testing of Different Antibiotics According to Clsi 25, Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae, Detection of Resistance Gene in Isolates Using Conventional Pcr, Detection of Some Virulence Genes Using Conventional Pcr
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jan 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.
Specimen Collection : Clinical specimens included blood, urine, bronchoalveolar lavage fluid, wound, peritoneal fluid, and tracheal aspirate obtained from patients with suspected bacterial infections collected in dry sterile well-closed plastic cups.
Bacterial identification by Gram stain, culture and biochemical rections
- analysisThe resistance pattern of the isolates will be detected by disc diffusion method.
- phenotypic detection of carbapenemases. • Detection of carbapenem resistance genes (KPC, VIM, IMP, OXA-48, NDM) by conventional PCR.
Detailed description
Carbapenem-resistant Enterobacterales (CRE) poses an urgent global public health threat, with more than 1,100 documented deaths, as reported in a 2019 antibiotic resistance publication by the U.S. Centers for Disease Control and Prevention.
Carbapenem-resistant Enterobacterales, including carbapenem-resistant Klebsiella pneumoniae (CRKP), is associated with higher mortality compared with infections caused by carbapenem-susceptible Enterobacterales infections Specimen Collection : Clinical specimens included blood, urine, bronchoalveolar lavage fluid, wound, peritoneal fluid, and tracheal aspirate obtained from patients with suspected bacterial infections collected in dry sterile well-closed plastic cups.
Bacterial identification by Gram stain, culture and biochemical rections
- analysisThe resistance pattern of the isolates will be detected by disc diffusion method.
- phenotypic detection of carbapenemases. • Detection of carbapenem resistance genes (KPC, VIM, IMP, OXA-48, NDM) by conventional PCR.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 patients with klebsiella pneumoniae infection | – | Genetic: . - Genotypic detection of carbapenemase genes by conventional PCR.Infections caused by klebsiella pneumoniae like skin infections, chest infections, surgical site infections, and urinary tract Infections. |
| Group 2 patients without klebsiella pneumoniae | – | Genetic: . - Genotypic detection of carbapenemase genes by conventional PCR.Infections caused by any organisms other than klebsiella pneumoniae and carbapenem resistant klebsiella pneumoniae by mechanism other than carbapenemases production. |
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 (0 listed)
Key exclusion criteria (1 listed)
- Infections caused by any organisms other than klebsiella pneumoniae and carbapenem resistant klebsiella pneumoniae by mechanism other than carbapenemases production.
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 carbapenemase genes by conventional PCR.Specimen Collection : Clinical specimens included blood, urine, bronchoalveolar lavage fluid, wound, peritoneal fluid, and tracheal aspirate obtained from patients with suspected bacterial infections collected in dry sterile well-closed plastic cups. Bacterial identification by Gram stain, culture and biochemical rections - analysisThe resistance pattern of the isolates will be detected by disc diffusion method. - phenotypic detection of carbapenemases. • Detection of carbapenem resistance genes (KPC, VIM, IMP, OXA-48, NDM) by conventional PCR. | Genetic | Group 1 patients with klebsiella pneumoniae infection, Group 2 patients without klebsiella pneumoniae |
Primary outcome
1 ISOLATION OF KLEB. by culture on macConkey agar
Time frame: 6 months from January to may
Antibiotic sensitivity testing of different antibiotics according to clsi 25
Time frame: 6 months from January to may
Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae
Time frame: 6 months from January to may
Detection of resistance gene in isolates using conventional pcr
Time frame: 6 months from June to December
Detection of some virulence genes using conventional pcr
Time frame: 6 months from June to December
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 27 Jan 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 ISOLATION OF KLEB. by Culture on macConkey Agar and Antibiotic Sensitivity Testing of Different Antibiotics According to Clsi 25, 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 0 inclusion and 1 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 27 Jan 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 Walaa Ismael, Demonstrator (+20114 8736091, walaa.marzouk@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 ISOLATION OF KLEB. by culture on macConkey agar (time frame: 6 months from January to may). The study lists 5 primary outcomes in all. 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 27 Jan 2026.