UTIUrinary tractNCT06859814
Value of Infection Control Programs on Infection Associated with Urinary Tract Catheterization in Sohag University Hospital
A study testing urinary catheterization in people with UTI, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effectiveness of an infection control program implemented at Sohag University Hospital in reducing the incidence of catheter-associated urinary tract infections (CAUTIs) among patients requiring urinary catheterization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- UTI
- What is being tested?
- urinary catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥ 18 years) who are catheterized during their hospitalization. Patients who provide informed consent to participate in the study.
Who cannot join
- Patients with a known history of urinary tract infections prior to hospitalization.
- Patients who have indwelling catheters for more than 14 days before the study. Patients with urinary tract anomalies or other conditions that may affect infection rates.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospitals
Sohag, Sohag Governorate, 82738
Laila Mohamed Yousef, professor of clinica pathology, 00201002976973, lelysaeed@yahoo.com
About this study
The aim of this study is to evaluate the effectiveness of an infection control program implemented at Sohag University Hospital in reducing the incidence of catheter-associated urinary tract infections (CAUTIs) among patients requiring urinary catheterization.
- Conditions
- UTI
- Being tested
- urinary catheterization
- Keywords
- UTI, Urinary catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urinary catheterizationProcedure or surgery
urine samples for culture and sensitivity will be collected in patients having urinary tract infection and we will use sterile container 50cc for urine sampling culture on blood or macconkey medium for detection type of organism .
| Study group | Role | What they receive |
|---|---|---|
| Patients with urinary catheters | Experimental | Adult patients (≥ 18 years) who are catheterized during their hospitalization. Receives: Procedure: urinary catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CAUTIs:
The primary outcome will be the rate of CAUTIs before and after the implementation of the infection control program. CAUTIs will be defined according to the criteria established by the Centers for Disease Control and Prevention (CDC) and will include clinical signs, symptoms, and positive urine cultures.
Measured: one month
Secondary outcomes (1)
Length of Hospital Stay:
The average length of stay for patients with CAUTIs will be compared preand post-intervention. A reduction in length of stay may indicate improved patient outcomes and decreased complications.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Feb 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UTIStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mosleh, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859814
- Sponsor's protocol ID
- Soh-Med--25-2-01MS
- Acronym
- Urinary tract
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Infection Control Programs on Infection Associated with Urinary Tract Catheterization in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06859814
- Acronym / sponsor ID
- Urinary tract / Soh-Med--25-2-01MS
- Conditions
- UTI
- Keywords
- UTI, Urinary catheterization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 5 Mar 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.
The aim of this study is to evaluate the effectiveness of an infection control program implemented at Sohag University Hospital in reducing the incidence of catheter-associated urinary tract infections (CAUTIs) among patients requiring urinary catheterization.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with urinary catheters | Experimental | Procedure: urinary catheterizationAdult patients (≥ 18 years) who are catheterized during their hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (≥ 18 years) who are catheterized during their hospitalization. Patients who provide informed consent to participate in the study.
Key exclusion criteria (2 listed)
- Patients with a known history of urinary tract infections prior to hospitalization.
- Patients who have indwelling catheters for more than 14 days before the study. Patients with urinary tract anomalies or other conditions that may affect infection rates.
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 |
|---|---|---|
| urinary catheterizationurine samples for culture and sensitivity will be collected in patients having urinary tract infection and we will use sterile container 50cc for urine sampling culture on blood or macconkey medium for detection type of organism . | Procedure or surgery | Patients with urinary catheters |
Primary outcome
Incidence of CAUTIs:
Time frame: one month
The primary outcome will be the rate of CAUTIs before and after the implementation of the infection control program. CAUTIs will be defined according to the criteria established by the Centers for Disease Control and Prevention (CDC) and will include clinical signs, symptoms, and positive urine cultures.
1 secondary outcome
Length of Hospital Stay:
Time frame: one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urinary catheterization in people with UTI, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 10 Mar 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed mahmoud mohamed Mosleh, MBBCH (00201003565342, nmosleh41@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CAUTIs: (time frame: one month). 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 10 Mar 2025.