Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae

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.

Study Overview

• Status: Not yet recruiting
• 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
• Intervention / Treatment: Genetic: . - Genotypic detection of carbapenemase genes 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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Walaa Ismael, Demonstrator; Phone Number: +20114 8736091; Email: walaa.marzouk@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Faculty of medicine Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria: Infections caused by klebsiella pneumoniae like skin infections, chest infections, surgical site infections, and urinary tract Infections.-

Exclusion Criteria:

• Infections caused by any organisms other than klebsiella pneumoniae and carbapenem resistant klebsiella pneumoniae by mechanism other than carbapenemases production.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 patients with klebsiella pneumoniae infection; Infections caused by klebsiella pneumoniae like skin infections, chest infections, surgical site infections, and urinary tract Infections.	Genetic: . - 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.
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.	Genetic: . - 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1 ISOLATION OF KLEB. by culture on macConkey agar	6 months from January to may
Antibiotic sensitivity testing of different antibiotics according to clsi 25	6 months from January to may
Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae	6 months from January to may
Detection of resistance gene in isolates using conventional pcr	6 months from June to December
Detection of some virulence genes using conventional pcr	6 months from June to December

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 10, 2026
• First Submitted That Met QC Criteria: January 17, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 17, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med-25-12-2MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No