T2DM (Type 2 Diabetes Mellitus)NCT07188935
Glycemia and Antibiotic Efficacy in Diabetic Recurrent UTIs
A study testing ciprofloxacin 500 mg tablet in people with T2DM (Type 2 Diabetes Mellitus), run by Al-Mustansiriyah University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- ciprofloxacin 500 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteIraq
- Study dates
- 30 Oct 2024to 20 Jun 2025
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Al-Zahraa Teaching Hospital, Wasit, Iraq
Kut, Wasit Governorate, 52001
About this study
Official title: Effect of Glycemic Status on Antimicrobial Response in T2DM Patients With Recurrent UTI, Prospective Comparative Study
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.
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Being tested
- ciprofloxacin 500 mg tablet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciprofloxacin 500 mg tabletDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-diabetic patients with recurrent UTI | Active comparator | Non diabetic patients with recurrent UTI receiving treatment Receives: Drug: ciprofloxacin 500 mg tablet |
| Diabetic patients with recurrent UTI | Other | Diabetic patients with recurrent UTI receiving treatments Receives: Drug: ciprofloxacin 500 mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Day 30 after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start30 Oct 2024
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maher Kadhum, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188935
- Sponsor's protocol ID
- MustansiriyahU ,80 ,3/m9/2024
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glycemic Status on Antimicrobial Response in T2DM Patients With Recurrent UTI, Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07188935
- Acronym / sponsor ID
- MustansiriyahU ,80 ,3/m9/2024
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 23 Sep 2025 (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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-diabetic patients with recurrent UTI | Active comparator | Drug: ciprofloxacin 500 mg tabletNon diabetic patients with recurrent UTI receiving treatment |
| Diabetic patients with recurrent UTI | Other | Drug: ciprofloxacin 500 mg tabletDiabetic patients with recurrent UTI receiving treatments |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
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 |
|---|---|---|
| ciprofloxacin 500 mg tabletAdministration 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. | Drug | Diabetic patients with recurrent UTI, Non-diabetic patients with recurrent UTI |
Primary outcome
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
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
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 24 Sep 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ciprofloxacin 500 mg tablet in people with T2DM (Type 2 Diabetes Mellitus), run by Al-Mustansiriyah University at 1 site in Iraq.
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 6 inclusion and 7 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 24 Sep 2025. 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 Iraq. 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?
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). 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?
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 24 Sep 2025.