Clinical trial NCT05674942: Urinary Tract Infection in Patients With Chronic Kidney Disease
Official title: Urinary Tract Infection in Patients With Chronic Kidney Disease: A Retrospective Observational Study at Outpatient Nephrology Clinics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Chronic Kidney Diseases
Keywords: urinary tract
infection
chronic kidney disease
UTI
CKD
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from outpatient nephrology clinics in Alexandria.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Males and non-pregnant females aged ≥ 18 years old
2. Patients with CKD stages (G1 to G4)
3. Patients diagnosed with UTI due to urine culture

Exclusion Criteria:

1. Non-CKD patients
2. pregnant females
3. CKD patients on immunosuppressant agents
4. ESRD patients on hemodialysis
5. Patients with structural abnormalities which make them liable to frequent UTI

Primary outcomes:
measure: prevalence of UTI in CKD patients
timeFrame: records will be retrospectively screened from January 2019 till September 2022
measure: isolated microorganisms causing UTI in CKD patients
timeFrame: records will be retrospectively screened from January 2019 till September 2022
Secondary outcomes:
measure: sensitivity pattern of urine cultures in CKD
timeFrame: records will be retrospectively screened from January 2019 till September 2022
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Alexandria University
Study officials:
affiliation: Lecturer of Nephrology & Internal Medicine, Faculty of medicine, Alexandria University
name: mohamed mamdouh elsayed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nephrology Lecturer, School of Medicine, New Giza University (NGU), Giza, Egypt
name: Mohammed Abdel Gawad
role: STUDY_CHAIR
affiliation: Faculty of Pharmacy, Pharos University, Alexandria, Egypt
name: Dalia Elzayat
role: STUDY_CHAIR
affiliation: Faculty of Pharmacy, Pharos University, Alexandria, Egypt
name: Reham Mekawy
role: STUDY_CHAIR
affiliation: Faculty of Pharmacy, Pharos University, Alexandria, Egypt
name: Salma Mahdy
role: STUDY_CHAIR
affiliation: Faculty of Pharmacy, Pharos University, Alexandria, Egypt
name: Salma Imam
role: STUDY_CHAIR
affiliation: Faculty of Pharmacy, Pharos University, Alexandria, Egypt
name: Hala Abo El-hassan
role: STUDY_CHAIR
affiliation: Department of Clinical Pharmacy, Kidney and Urology Center, Alexandria, Egypt
name: Ramy Elwaraky
role: STUDY_CHAIR
affiliation: Clinical Pharmacist, Alexandria Main University Hospital, Alexandria, Egypt
name: Engy Emam
role: STUDY_CHAIR
References:
citation: 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.
citation: Gouda 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.
citation: Dimitrijevic 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.