NCT05630326

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2022

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2023

Completed
Last Updated

July 27, 2023

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

April 7, 2022

Last Update Submit

July 24, 2023

Conditions

Keywords

Chronic Kidney DiseasesAcute Kidney InjuryUTIs in infantsESBL UTIschronic renal failureUTIs with COVID-19ESBL organisms with COVID-19

Outcome Measures

Primary Outcomes (1)

  • Assessment risk factors , prevalence, and the relation between ESBL UTI and COVID-19 infection of all infants with ESBL- UTIs

    1year

Study Arms (4)

ESBL UTI

all infants with UTIs caused by ESBL producing organisms

Other: comparing, prevalence

Non-ESBL UTI

all infants with UTIs caused by non-ESBL producing organisms

Other: assessment

ESBL UTI with COVID-19

all infants with UTIs caused by ESBL producing organisms with COVID-19 infection

Other: association

ESBL UTI without COVID-19

all infants with UTIs caused by ESBL producing organisms without COVID-19 infection

Other: evaluation

Interventions

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

Also known as: Data on clinical and laboratory findings are reviewed from medical records for details
ESBL UTI

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

Non-ESBL UTI

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

ESBL UTI with COVID-19

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

ESBL UTI without COVID-19

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • All infants with UTIs who had been treated

You may not qualify if:

  • Patient with a mixed urine culture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

Location

MeSH Terms

Conditions

Renal InsufficiencyRenal Insufficiency, ChronicAcute Kidney InjuryKidney Failure, Chronic

Interventions

PrevalenceRestraint, PhysicalAssociation

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorbidityVital StatisticsData CollectionEpidemiologic MethodsInvestigative TechniquesDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilizationPsychotherapeutic ProcessesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mahmoud Alhandi Omar Helal

    Hamad Medical Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2022

First Posted

November 29, 2022

Study Start

March 1, 2023

Primary Completion

July 1, 2023

Study Completion

July 20, 2023

Last Updated

July 27, 2023

Record last verified: 2022-04

Locations