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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04244526
Other study ID # Urinary tract infection
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date May 1, 2021

Study information

Verified date January 2020
Source Assiut University
Contact Noura Samir Hussein, Demonstrator
Phone 00201002606302
Email Noura011456@med.au.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

- to describe the profile of uropathogenic E coli from Egyptian pregnant women with UTIs and a symptomatic bacteriuria.

- to determine the susceptibility pattern of our local isolated UPEC strains which is essential for optimal management of UTI.

- to evaluate the different virulence genes in UPEC isolates and their association with antibiotic resistance.

- to track common UPEC serogroups.

- to investigate the biofilm formation and the relationship between virulence genes and biofilm formation in UPEC strains isolated from patients.


Description:

Urinary tract infection represents the most common bacterial infection in pregnancy and the third common cause of human infection after respiratory and intestinal infections. The infection can be life threatening and associated with serious complications. UTI can be associated with defined symptoms'symptomatic' or without symptoms 'asymptomatic'. Asymptomatic bacteriuria is defined as the presence of >100000 colony forming units/ml of urine of a single pathogen in two consecutive midstream clean catch urine specimen or on catheterization specimen from an individual without signs or symptoms associated with urinary or genital organs. Asymptomatic bacteriuria can lead to acute pyelonephritis in30%of pregnant women and complications such as early delivery, increase risk of hypertension, pre-eclampsia, low birth weight and postpartum endometritis. Ecoli accounts for most cases of symptomatic and asymptomatic bacteriuria in women, representing70 _90 %of the cases. The important virulence factors of uropathogenic ecoli can be broadly divided into two groups :bacterial cell surface factors and secreted factors. The emergence of drug resistant microorganism among Uropathogenic Escherichia coli strains increases the serious threat to global health. Ecoli often acquired genes coding for antibiotic resistance, beta-lactamase enzymes are the most frequent and play a key role, conferring resistance of bacteria to beta lactam antibiotic group such as penicillin and cephalosporins. Therefore, knowledge regarding local prevalence of uropathogenic ecoli and antimicrobial resistance is essential for optimal management of UTI.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 155
Est. completion date May 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- pregnant women who diagnosed through clinical examination and urine analysis. 3 groups : group 1 pregnant women with cystitis Group 2 pregnant women with Pyelonephritis Group 3 pregnant women with asymptomatic bacteriuria

Exclusion Criteria:

- pregnant women on antibiotics _Patients with any anatomical abnormalities in the urinary tract

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Talking a urine sample
Just taking a urine sample

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary The percentage of virulence genes in different isolated UPEC strains Measurment of virulence genes of Escherichia coli strains by molecular diagnosis as PCR technique to determine relationship between clinical presentation of urinary tract infection and distribution of virulence genes of strains Three months
Secondary Correlation between the virulence genes and antibiotic resistance Measurment of virulence genes of escherichia coli strains by molecular diagnosis as PCR technique,and determine antibiotic susceptibility of ecoli strains between different groups of women to determine relationship between distribution of virulence genea and antibiotic susceptibility of strains Seven months
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