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临床试验/NCT07188935
NCT07188935已完成不适用

Effect of Glycemic Status on Antimicrobial Response in T2DM Patients With Recurrent UTI, Prospective Comparative Study

Al-Mustansiriyah University1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2024年10月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
99
试验地点
1
主要终点
treatment success will be defined as simultaneous absence of symptoms and GUE showing <5 pus cells/HPF and MARS-10 score ≥8. Unit of measure: % of participants meeting all criteria.

研究概览

简要总结

This study looked at how blood sugar control affects treatment of repeated urinary tract infections (UTIs) in people with type 2 diabetes. Ninety-nine patients at Al-Zahraa Teaching Hospital in Iraq were included. Some patients had good blood sugar control, while others did not. All were treated with antibiotics, and doctors checked if the infection was cured after 14 days and if it came back within 30 days. The study helps show how diabetes management can affect recovery from UTIs and the chance of infection returning.

详细描述

Recurrent urinary tract infections (rUTIs) are a frequent complication among patients with type 2 diabetes mellitus (T2DM), associated with impaired immune function, glycosuria, and increased risk of antimicrobial resistance. While UTIs are common in both diabetic and non-diabetic patients, recurrence rates and treatment failures are higher in T2DM. Few prospective studies have evaluated the effect of glycemic control on antimicrobial response in this population.

This prospective comparative study enrolled 99 patients with recurrent UTIs, including 58 with T2DM, at Al-Zahraa Teaching Hospital, Wasit Province, Iraq. Patients with diabetes were stratified into groups based on glycemic control (good vs. poor). Antimicrobial therapy was administered according to hospital guidelines, and treatment response was evaluated after 14 days (clinical cure). Patients were followed for 30 days to monitor recurrence.

The primary objective was to assess whether glycemic status influences antimicrobial treatment outcomes in patients with rUTIs. Secondary objectives included evaluating recurrence rates and identifying potential risk factors for treatment failure. Findings from this study highlight the importance of optimizing glycemic control as part of the overall management of recurrent UTIs in patients with T2DM.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age >18 years, both sex
  • Patient with known history of T2DM at least 1 year
  • Patients diagnosed with rUTI according to the positive GUE as in practice guideline
  • Patients with different glycemic status according to the HbA1c level, and on different treatment for T2DM accordingly.
  • Patients with non-diabetic rUTI as active comparator.
  • Patients who had the ability to communicate to answer study questionnaire.
  • Exclusion criteria:
  • Type 1 diabetic patients on insulin therapy were excluded.
  • T2DM Patients who were using Sodium-glucose co-transporter-2 inhibitors (SGLT-2) (because of their renal -related side effect).
  • Patients who received any antimicrobial treatment within the last 72 hours of their enrollment.
  • Women patients with recurrent vaginitis or urinary incontinence.
  • Men patients with BPH or over flow incontinence ( as a cause for r UTI).
  • Patients with chronic disease other than T2DM that may cause rUTI ( eg. CKD, Spinal cord injury. kidney stone).
  • Pregnancy and lactation

排除标准

  • 未提供

研究组 & 干预措施

Non-diabetic patients with recurrent UTI

Active Comparator

Non diabetic patients with recurrent UTI receiving treatment

干预措施: ciprofloxacin 500 mg tablet (Drug)

Diabetic patients with recurrent UTI

Other

Diabetic patients with recurrent UTI receiving treatments

干预措施: ciprofloxacin 500 mg tablet (Drug)

结局指标

主要结局

treatment success will be defined as simultaneous absence of symptoms and GUE showing <5 pus cells/HPF and MARS-10 score ≥8. Unit of measure: % of participants meeting all criteria.

时间窗: Up to 14 days after completion of antimicrobial therapy

treatment success will be defined as simultaneous absence of symptoms and GUE showing <5 pus cells/HPF after 30 days of treatment initiation

时间窗: Day 30 after treatment initiation

次要结局

未报告次要终点

研究者

发起方
Al-Mustansiriyah University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maher Kadhum

Clinical Researcher

Al-Mustansiriyah University

研究点 (1)

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