Urinary Tract InfectionsNCT05674942
Urinary Tract Infection in Patients With Chronic Kidney Disease
An observational study of Urinary Tract Infections and Chronic Kidney Diseases, run by Alexandria University at 1 site in Egypt.
Trial summary
This study aims to investigate the etiology and associated risk factors for UTI in Egyptian chronic kidney disease patients. In addition, to identify the isolated micro-organisms and their sensitivity patterns for better anticipation of treatment regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections, Chronic Kidney Diseases
- What is being tested?
- Patients with urinary tract infection and chronic kidney disease
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 15 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from outpatient nephrology clinics in Alexandria.
Who may be able to join
- Males and non-pregnant females aged ≥ 18 years old
- Patients with CKD stages (G1 to G4)
- Patients diagnosed with UTI due to urine culture
Who cannot join
- Non-CKD patients
- pregnant females
- CKD patients on immunosuppressant agents
- ESRD patients on hemodialysis
- Patients with structural abnormalities which make them liable to frequent UTI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urinary Tract Infection in Patients With Chronic Kidney Disease: A Retrospective Observational Study at Outpatient Nephrology Clinics
This study aims to investigate the etiology and associated risk factors for UTI in Egyptian chronic kidney disease patients. In addition, to identify the isolated micro-organisms and their sensitivity patterns for better anticipation of treatment regimen.
Read the detailed description
Chronic kidney disease (CKD) patients are at higher risk of urinary tract infections (UTI), as CKD is a state of chronic inflammation, metabolic disturbance and impaired immunocompetence. Moreover, patient with CKD are usually of advanced age and suffer from other comorbidities such as diabetes, hypertension, obesity, and cardiovascular diseases, which also add to their risk of infection.
UTI comprises heterogeneous conditions ranging from mild cystitis, easily treated with oral antibiotics, to life-threatening sepsis and multiple organ failure.
There is scarce information about risk factors of recurrence of UTI and infection with multidrug-resistant organisms in the Egyptian population.
- Conditions
- Urinary Tract Infections, Chronic Kidney Diseases
- Being tested
- Patients with urinary tract infection and chronic kidney disease
- Keywords
- urinary tract, infection, chronic kidney disease, UTI, CKD
- Medical subject headings
- Urinary Tract Infections, Renal Insufficiency, Chronic, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with urinary tract infection and chronic kidney diseaseOther
The data that will be collected from the electronic patient records at the clinics through a google form will include sociodemographic (age, sex, weight and occupation), comorbidities (e.g., HTN, DM), medications used, renal functions (serum creatinine, and CKD stage calculated by 2021 CKD-EPI creatinine equation), and in case of positive urine culture (type of microorganism and antibiogram).
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of UTI in CKD patients
percentage of UTI in CKD patients
Measured: records will be retrospectively screened from January 2019 till September 2022
isolated microorganisms causing UTI in CKD patients
isolated microorganisms in cultures causing UTI in CKD patients
Measured: records will be retrospectively screened from January 2019 till September 2022
Secondary outcomes (1)
sensitivity pattern of urine cultures in CKD
describe sensitivity pattern of urine cultures in CKD
Measured: records will be retrospectively screened from January 2019 till September 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Jun 2023
- Primary completion15 Apr 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University
- Investigators
- mohamed mamdouh elsayed, MD, Principal investigator, Lecturer of Nephrology & Internal Medicine, Faculty of medicine, Alexandria UniversityMohammed Abdel Gawad, Study chair, Nephrology Lecturer, School of Medicine, New Giza University (NGU), Giza, EgyptDalia Elzayat, Study chair, Faculty of Pharmacy, Pharos University, Alexandria, EgyptReham Mekawy, Study chair, Faculty of Pharmacy, Pharos University, Alexandria, EgyptSalma Mahdy, Study chair, Faculty of Pharmacy, Pharos University, Alexandria, EgyptSalma Imam, Study chair, Faculty of Pharmacy, Pharos University, Alexandria, EgyptHala Abo El-hassan, Study chair, Faculty of Pharmacy, Pharos University, Alexandria, EgyptRamy Elwaraky, Study chair, Department of Clinical Pharmacy, Kidney and Urology Center, Alexandria, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674942
- Sponsor's protocol ID
- Urinary Tract Infection
- Status last verified
- Jun 2024
- First submitted
- 14 Dec 2022
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scherberich JE, Funfstuck R, Naber KG. Urinary tract infections in patients with renal insufficiency and dialysis - epidemiology, pathogenesis, clinical symptoms, diagnosis and treatment. GMS Infect Dis. 2021 Dec 21;9:Doc07. doi: 10.3205/id000076. eCollection 2021.
PubMed 35106269Gouda Z, Mashaal G, Bello AK, El Attar A, El Kemmry T, El Reweny A, El Nahas M. Egypt Information, Prevention, and Treatment of Chronic Kidney Disease (EGIPT-CKD) programme: prevalence and risk factors for microalbuminuria among the relatives of patients with CKD in Egypt. Saudi J Kidney Dis Transpl. 2011 Sep;22(5):1055-63.
PubMed 21912051Dimitrijevic Z, Paunovic G, Tasic D, Mitic B, Basic D. Risk factors for urosepsis in chronic kidney disease patients with urinary tract infections. Sci Rep. 2021 Jul 13;11(1):14414. doi: 10.1038/s41598-021-93912-3.
PubMed 34257397
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Tract Infection in Patients With Chronic Kidney Disease: A Retrospective Observational Study at Outpatient Nephrology Clinics
- ClinicalTrials.gov ID
- NCT05674942
- Acronym / sponsor ID
- Urinary Tract Infection
- Conditions
- Urinary Tract Infections, Chronic Kidney Diseases
- Keywords
- urinary tract, infection, chronic kidney disease, UTI, CKD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 9 Jan 2023 (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.
This study aims to investigate the etiology and associated risk factors for UTI in Egyptian chronic kidney disease patients. In addition, to identify the isolated micro-organisms and their sensitivity patterns for better anticipation of treatment regimen.
Detailed description
Chronic kidney disease (CKD) patients are at higher risk of urinary tract infections (UTI), as CKD is a state of chronic inflammation, metabolic disturbance and impaired immunocompetence. Moreover, patient with CKD are usually of advanced age and suffer from other comorbidities such as diabetes, hypertension, obesity, and cardiovascular diseases, which also add to their risk of infection.
UTI comprises heterogeneous conditions ranging from mild cystitis, easily treated with oral antibiotics, to life-threatening sepsis and multiple organ failure.
There is scarce information about risk factors of recurrence of UTI and infection with multidrug-resistant organisms in the Egyptian population.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from outpatient nephrology clinics in Alexandria.
Key inclusion criteria (3 listed)
- Males and non-pregnant females aged ≥ 18 years old
- Patients with CKD stages (G1 to G4)
- Patients diagnosed with UTI due to urine culture
Key exclusion criteria (5 listed)
- Non-CKD patients
- pregnant females
- CKD patients on immunosuppressant agents
- ESRD patients on hemodialysis
- Patients with structural abnormalities which make them liable to frequent UTI
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 |
|---|---|---|
| Patients with urinary tract infection and chronic kidney diseaseThe data that will be collected from the electronic patient records at the clinics through a google form will include sociodemographic (age, sex, weight and occupation), comorbidities (e.g., HTN, DM), medications used, renal functions (serum creatinine, and CKD stage calculated by 2021 CKD-EPI creatinine equation), and in case of positive urine culture (type of microorganism and antibiogram). | Other | – |
Primary outcome
prevalence of UTI in CKD patients
Time frame: records will be retrospectively screened from January 2019 till September 2022
percentage of UTI in CKD patients
isolated microorganisms causing UTI in CKD patients
Time frame: records will be retrospectively screened from January 2019 till September 2022
isolated microorganisms in cultures causing UTI in CKD patients
1 secondary outcome
sensitivity pattern of urine cultures in CKD
Time frame: records will be retrospectively screened from January 2019 till September 2022
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 18 Jun 2024.
- Background: PubMed 35106269Scherberich JE, Funfstuck R, Naber KG. Urinary tract infections in patients with renal insufficiency and dialysis - epidemiology, pathogenesis, clinical symptoms, diagnosis and treatment. GMS Infect Dis. 2021 Dec 21;9:Doc07. doi: 10.3205/id000076. eCollection 2021.
- Background: PubMed 21912051Gouda Z, Mashaal G, Bello AK, El Attar A, El Kemmry T, El Reweny A, El Nahas M. Egypt Information, Prevention, and Treatment of Chronic Kidney Disease (EGIPT-CKD) programme: prevalence and risk factors for microalbuminuria among the relatives of patients with CKD in Egypt. Saudi J Kidney Dis Transpl. 2011 Sep;22(5):1055-63.
- Background: PubMed 34257397Dimitrijevic Z, Paunovic G, Tasic D, Mitic B, Basic D. Risk factors for urosepsis in chronic kidney disease patients with urinary tract infections. Sci Rep. 2021 Jul 13;11(1):14414. doi: 10.1038/s41598-021-93912-3.
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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.
mohamed mamdouh elsayed, MD principal investigator
Lecturer of Nephrology & Internal Medicine, Faculty of medicine, Alexandria University
Mohammed Abdel Gawad study chair
Nephrology Lecturer, School of Medicine, New Giza University (NGU), Giza, Egypt
Dalia Elzayat study chair
Faculty of Pharmacy, Pharos University, Alexandria, Egypt
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 Urinary Tract Infections and Chronic Kidney Diseases, run by Alexandria University at 1 site in Egypt.
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 3 inclusion and 5 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 18 Jun 2024. 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 Egypt. 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?
prevalence of UTI in CKD patients (time frame: records will be retrospectively screened from January 2019 till September 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05674942, which also lists 3 linked publications.
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 18 Jun 2024.