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

NCT ID: NCT05630326

Last Updated: 2023-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

5600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-07-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ESBL UTI

all infants with UTIs caused by ESBL producing organisms

comparing, prevalence

Intervention Type OTHER

Comparing infants with UTIs caused by ESBL organism, or non ESBL organism.

Non-ESBL UTI

all infants with UTIs caused by non-ESBL producing organisms

assessment

Intervention Type OTHER

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

association

Intervention Type OTHER

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

evaluation

Intervention Type OTHER

comparing ESBLUTI with COVID-19 and ESBL UTI without COVID-19

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

comparing, prevalence

Comparing infants with UTIs caused by ESBL organism, or non ESBL organism.

Intervention Type OTHER

assessment

comparing infants with UTIs caused by ESBL organism, or non ESBL organism.

Intervention Type OTHER

association

comparing ESBLUTI with COVID-19 and ESBL UTI without COVID-19

Intervention Type OTHER

evaluation

comparing ESBLUTI with COVID-19 and ESBL UTI without COVID-19

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Data on clinical and laboratory findings are reviewed from medical records for details

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All infants with UTIs who had been treated

Exclusion Criteria

* Patient with a mixed urine culture.
Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hamad Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mahmoud Alhandi Omar Helal

Role: PRINCIPAL_INVESTIGATOR

Hamad Medical Corporation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hamad Medical Corporation

Doha, , Qatar

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Qatar

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MRC-01-22-158

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Maternal- Fetal Infection
NCT03371056 UNKNOWN NA