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CompletedNCT07188935Updated Sep 24, 2025

Glycemia and Antibiotic Efficacy in Diabetic Recurrent UTIs

An interventional study of ciprofloxacin 500 mg tablet in T2DM (Type 2 Diabetes Mellitus), sponsored by Al-Mustansiriyah University. Completed at 1 site in Iraq. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-24.

Sponsored by Al-Mustansiriyah University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Oct 2024, registered Sep 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
99
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • T2DM (Type 2 Diabetes Mellitus)
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 99 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Al-Mustansiriyah University is the lead sponsor of 31 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
99 participants (actual)

Study arms

  • Active comparator
    Non-diabetic patients with recurrent UTI

    Non diabetic patients with recurrent UTI receiving treatment

    Drug: ciprofloxacin 500 mg tablet

  • Other
    Diabetic patients with recurrent UTI

    Diabetic patients with recurrent UTI receiving treatments

    Drug: ciprofloxacin 500 mg tablet

Interventions

  • Drugciprofloxacin 500 mg tablet

    Administration of oral ciprofloxacin 500 mg twice daily for 7-14 days for the treatment of recurrent urinary tract infections in patients with type 2 diabetes mellitus, following local and international guidelines.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 14 days after completion of antimicrobial therapy

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

    Time frame: Day 30 after treatment initiation

07

Study locations

1 site
  • Al-Zahraa Teaching Hospital, Wasit, Iraq
    Kut, Wasit Governorate 52001, Iraq
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07188935
Lead sponsor
Al-Mustansiriyah University
Responsible party
Maher Kadhum (Clinical Researcher, Al-Mustansiriyah University) — Principal investigator
First posted
Sep 23, 2025
Start date
Oct 30, 2024
Primary completion
Jun 20, 2025
Completion
Jun 20, 2025
Last update
Sep 24, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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