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Clinical Trials/NCT07369518
NCT07369518
Not yet recruiting
Not Applicable

Effect of Ceftazidime-Avibactam Against Carbapenemase-Positive Klebsiella Pneumoniae Causing Health Care-Associated Infections

Sohag University1 site in 1 country100 target enrollmentStarted: January 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
100
Locations
1
Primary Endpoint
1 ISOLATION OF KLEB. by culture on macConkey agar

Overview

Brief 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.

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

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Group 1 patients with klebsiella pneumoniae infection

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

Intervention: . - Genotypic detection of carbapenemase genes by conventional PCR. (Genetic)

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.

Intervention: . - Genotypic detection of carbapenemase genes by conventional PCR. (Genetic)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Walaa ismail Marzouk

Demonstrator at medical microbiology and immunology department faculty of medicine so

Sohag University

Study Sites (1)

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