Renal InsufficiencyABCUCEOINCT05630326
Association Between COVID-19 and UTIs Caused by ESBL Organism in Infants
An observational study of Renal Insufficiency, run by Hamad Medical Corporation at 1 site in Qatar.
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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- comparing, prevalence, assessment and association
- How many people
- 5,600 participants
- Where
- 1 siteQatar
- Study dates
- 1 Mar 2023to 20 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- All infants with UTIs who had been treated
Who cannot join
- Patient with a mixed urine culture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Insufficiency
- Being tested
- comparing, prevalence, assessment, association, evaluation
- Keywords
- Chronic Kidney Diseases, Acute Kidney Injury, UTIs in infants, ESBL UTIs, chronic renal failure, UTIs with COVID-19, ESBL organisms with COVID-19
- Medical subject headings
- Renal Insufficiency, Renal Insufficiency, Chronic, Acute Kidney Injury, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparing, prevalenceOther
Also called Data on clinical and laboratory findings are reviewed from medical records for details
Comparing infants with UTIs caused by ESBL organism, or non ESBL organism.
assessmentOther
comparing infants with UTIs caused by ESBL organism, or non ESBL organism.
associationOther
comparing ESBLUTI with COVID-19 and ESBL UTI without COVID-19
evaluationOther
comparing ESBLUTI with COVID-19 and ESBL UTI without COVID-19
| Study group | Role | What they receive |
|---|---|---|
| ESBL UTI | all infants with UTIs caused by ESBL producing organisms Receives: Other: comparing, prevalence | |
| Non-ESBL UTI | all infants with UTIs caused by non-ESBL producing organisms Receives: Other: assessment | |
| ESBL UTI with COVID-19 | all infants with UTIs caused by ESBL producing organisms with COVID-19 infection Receives: Other: association | |
| ESBL UTI without COVID-19 | all infants with UTIs caused by ESBL producing organisms without COVID-19 infection Receives: Other: evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment risk factors , prevalence, and the relation between ESBL UTI and COVID-19 infection of all infants with ESBL- UTIs
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Mar 2023
- Primary completion1 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 5,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alhandi Omar Helal, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630326
- Sponsor's protocol ID
- MRC-01-22-158
- Acronym
- ABCUCEOI
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Laboratory, and Radiological Characteristics of Urinary Tract Infections in Infants With COVID-19
- ClinicalTrials.gov ID
- NCT05630326
- Acronym / sponsor ID
- ABCUCEOI / MRC-01-22-158
- Conditions
- Renal Insufficiency
- Keywords
- Chronic Kidney Diseases, Acute Kidney Injury, UTIs in infants, ESBL UTIs, chronic renal failure, UTIs with COVID-19, ESBL organisms with COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,600 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ESBL UTI | – | Other: comparing, prevalenceall infants with UTIs caused by ESBL producing organisms |
| Non-ESBL UTI | – | Other: assessmentall infants with UTIs caused by non-ESBL producing organisms |
| ESBL UTI with COVID-19 | – | Other: associationall infants with UTIs caused by ESBL producing organisms with COVID-19 infection |
| ESBL UTI without COVID-19 | – | Other: evaluationall infants with UTIs caused by ESBL producing organisms without COVID-19 infection |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- All infants with UTIs who had been treated
Key exclusion criteria (1 listed)
- Patient with a mixed urine culture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparing, prevalenceAlso: Data on clinical and laboratory findings are reviewed from medical records for detailsComparing infants with UTIs caused by ESBL organism, or non ESBL organism. | Other | ESBL UTI |
| assessmentcomparing infants with UTIs caused by ESBL organism, or non ESBL organism. | Other | Non-ESBL UTI |
| associationcomparing ESBLUTI with COVID-19 and ESBL UTI without COVID-19 | Other | ESBL UTI with COVID-19 |
| evaluationcomparing ESBLUTI with COVID-19 and ESBL UTI without COVID-19 | Other | ESBL UTI without COVID-19 |
Primary outcome
Assessment risk factors , prevalence, and the relation between ESBL UTI and COVID-19 infection of all infants with ESBL- UTIs
Time frame: 1year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
Related trials for Renal Insufficiency
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Alhandi Omar Helal principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insufficiency, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment risk factors , prevalence, and the relation between ESBL UTI and COVID-19 infection of all infants with ESBL- UTIs (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.