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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05630326
Other study ID # MRC-01-22-158
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date July 20, 2023

Study information

Verified date April 2022
Source Hamad Medical Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Urinary tract infections (UTIs) in infants and young children are one of the most common bacterial infections, usually febrile illness without source, frequently due to Enterobacteriaceae, mainly Escherichia coli. Multidrug-resistant organisms including extended-spectrum beta-lactamase (ESBL) producing bacteria are becoming more prevalent. Due to the risk factors of ESBL-producing organisms in community-acquired (CA)-UTIs in infants in QATAR and Arab countries are still not studied because of the limited therapeutic options. hence, the importance of this study is to get knowledge about how to decrease the rapidly increasing in ESBL- producing bacteria, in infants, and to use antibiotics in a suitable guideline.so, The aim of this retrospective case-control study is to determine the clinical manifestations, and investigations of urinary tract infections among infants and the association with COVID-19 infection, in pediatric emergency centers at Hamad General Hospital - Qatar. From 1st January 2015 till 1st January 2022.


Description:

In this retrospective, case-control study investigators will include all infants (0-1 year) with UTIs who were treated at Hamad General Hospital, pediatric division- PEC Doha, Qatar, using the electronic medical records from 1st January 2015 till January 1st, 2022, diagnosed by a positive urine culture. Investigators will look for the clinical manifestations, radiological and laboratory findings, renal scarring, ESBL-organisms, prevalence, median age, gender, and ethnic background. Participants are divided into two groups: early infancy and late infancy, ESBL UTIs and non-ESBL UTIs, and upper UTIs and lower UTIs. Finally, UTIs ESBL with COVID-19 and without COVID_19.


Recruitment information / eligibility

Status Completed
Enrollment 5600
Est. completion date July 20, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Year
Eligibility Inclusion Criteria: - All infants with UTIs who had been treated Exclusion Criteria: - Patient with a mixed urine culture.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
comparing, prevalence
Comparing infants with UTIs caused by ESBL organism, or non ESBL organism.
assessment
comparing infants with UTIs caused by ESBL organism, or non ESBL organism.
association
comparing ESBLUTI with COVID-19 and ESBL UTI without COVID-19
evaluation
comparing ESBLUTI with COVID-19 and ESBL UTI without COVID-19

Locations

Country Name City State
Qatar Hamad Medical Corporation Doha

Sponsors (1)

Lead Sponsor Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment risk factors , prevalence, and the relation between ESBL UTI and COVID-19 infection of all infants with ESBL- UTIs 1year
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