Association Between COVID-19 and UTIs Caused by ESBL Organism in Infants (ABCUCEOI)

July 24, 2023 updated by: Hamad Medical Corporation

Clinical, Laboratory, and Radiological Characteristics of Urinary Tract Infections in Infants With COVID-19

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

5600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mahmoud Alhandi Omar Helal
  • Phone Number: 50074001
  • Email: Mhelal1@hamad.qa

Study Contact Backup

Study Locations

  • Qatar
      • Doha, Qatar
        • Hamad Medical Corporation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This retrospective review of electronic medical records from the pediatric division, Hamad General hospital in Doha, Qatar, will include all treated infants (0-1 years) who were diagnosed with UTI (Approximately 300 patients) between January 1, 2015, to january 1, 2022. Data collection will be done by co-investigators for all participants.

Description

Inclusion Criteria:

  • All infants with UTIs who had been treated

Exclusion Criteria:

  • Patient with a mixed urine culture.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ESBL UTI
all infants with UTIs caused by ESBL producing organisms
Other: comparing, prevalence
Comparing infants with UTIs caused by ESBL organism, or non ESBL organism.
Other Names:
  • Data on clinical and laboratory findings are reviewed from medical records for details
Non-ESBL UTI
all infants with UTIs caused by non-ESBL producing organisms
Other: assessment
comparing infants with UTIs caused by ESBL organism, or non ESBL organism.
ESBL UTI with COVID-19
all infants with UTIs caused by ESBL producing organisms with COVID-19 infection
Other: association
comparing ESBLUTI with COVID-19 and ESBL UTI without COVID-19
ESBL UTI without COVID-19
all infants with UTIs caused by ESBL producing organisms without COVID-19 infection
Other: evaluation
comparing ESBLUTI with COVID-19 and ESBL UTI without COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment risk factors , prevalence, and the relation between ESBL UTI and COVID-19 infection of all infants with ESBL- UTIs
Time Frame: 1year
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamad Medical Corporation

Investigators

  • Principal Investigator: Mahmoud Alhandi Omar Helal, Hamad Medical Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 20, 2023

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

November 22, 2022

First Posted (Actual)

November 29, 2022

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-01-22-158

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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