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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05141188
Other study ID # Soh-Med-21-10-10
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date November 1, 2022

Study information

Verified date November 2021
Source Sohag University
Contact Mayada S Amin
Phone 01098839535
Email maiada011200@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Urinary tract infection is among the most common nosocomial and community acquired infections. The Information on prevailing levels of antimicrobial resistance among common pathogens that associated with urinary tract infection is useful in making an appropriate choice of empiric therapy .Resistance to antibiotic treatment in patients with urinary tract infections (UTIs) is a representative example of the increasing problem of antimicrobial resistance. Extended-spectrum β-lactamases (ESBLs) has emerged as an important mechanism of resistance in Gram-negative bacteria.


Description:

Urinary tract infection is among the most common nosocomial and community acquired infections. The Information on prevailing levels of antimicrobial resistance among common pathogens that associated with urinary tract infection is useful in making an appropriate choice of empiric therapy . Resistance to antibiotic treatment in patients with urinary tract infections (UTIs) is a representative example of the increasing problem of antimicrobial resistance. Extended-spectrum β-lactamases (ESBLs) has emerged as an important mechanism of resistance in Gram-negative bacteria. Bacterial production of extended-spectrum β-lactamases (ESBL) significantly reduces the efficacy of the most commonly used beta-lactam antibiotics for the empiric therapy of infections caused by putative Gram-negative . Extended Spectrum Beta-Lactamase (ESBL) is derived from the mutated beta-lactamase enzyme, Beta-lactamase is an enzyme produced by bacteria that acts to inactivate beta-lactam class of antibiotics . Extended Spectrum Beta-Lactamase is most commonly produced by the Enterobacteriaceae group, especially Escherichia coli and Klebsiella pneumonia. ESBL-producing bacteria can also be resistant to the antibiotics class of aminoglycoside, fluoroquinolone, tetracycline, chloramphenicol, and sulfamethoxazole-trimethoprim. The presence of ESBL-producing bacteria in an infection can result in treatment failure. Antibiotic resistance causes a decrease in the effectiveness of treatment, increases transmission of infection, increases mortality, and increases the cost of health care, while the discovery of new antibiotics is getting less and less


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date November 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - This study will be conducted on a group of patients who are diagnosed that have urinary tract infections Exclusion Criteria: - The cases that do not give bacterial growth .

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Outcome

Type Measure Description Time frame Safety issue
Primary The aim of this study is to indicate the spread of extended spectrum beta lactamase producing gram negative bacteria ( that isolated from the urine of patients with urinary tract infections based on their susceptibility to antimicrobial agents ) This study will be conducted on a group of patients who are diagnosed that have urinary tract infections .
Methods of the study:
Antibiotic susceptibility will be examined on disk diffusion test on Mueller-Hinton agar (MHA) . The zones of growth inhibition around each of the antibiotic disks are measured to the nearest millimeter
through study completion, an average of 1 year
Primary The aim of this study is to indicate the spread of extended spectrum beta lactamase producing gram negative bacteria ( that isolated from the urine of patients with urinary tract infections based on their susceptibility to antimicrobial agents ) This study will be conducted on a group of patients who are diagnosed that have urinary tract infections .
Methods of the study:
Antibiotic susceptibility will be performed by automated method Vitek -2 system that measured by minimal inhibitory concentration (MIC) .
through study completion, an average of 1 year
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