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NCT Number: NCT05674942

Urinary Tract Infection in Patients With Chronic Kidney Disease

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.

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Key information

Conditions

Urinary Tract Infections Chronic Disease Chronic Kidney Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Alexandria University

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Patients with urinary tract infection and chronic kidney disease

Other

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).

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. sensitivity pattern of urine cultures in CKD

    Time frame: records will be retrospectively screened from January 2019 till September 2022

    describe sensitivity pattern of urine cultures in CKD

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Urinary Tract Infection in Patients With Chronic Kidney Disease: A Retrospective Observational Study at Outpatient Nephrology Clinics

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2023
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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