Urinary Tract Infection ComplicatedNCT06946667
Resistance Characteristics and Development of Diagnostic Model for Postoperative UTI in Patients With Kidney Stones
An observational study of Urinary Tract Infection Complicated and Kidney Stones, run by Xingxin Jiang at 1 site in China.
Trial summary
The combined detection of HBP, ADPN, NGAL, and hs-CRP enables the construction of a highly efficient diagnostic model, offering a novel strategy for early infection identification and risk stratification after surgery. Read more about this study
- Who is it for?
- Ages 44 to 62 years
- Conditions the study is for
- Urinary Tract Infection Complicated, Kidney Stones, Antimicrobial Resistance
- What is being tested?
- the UTI group and the Non-UTI group
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 9 Feb 2021to 31 Dec 2024
- Phase
- Observational
- 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 44 to 62 years
- All sexes
- No healthy volunteers
- Adult
Study population: A total of 130 patients diagnosed with kidney stones and treated at our hospital between February 2021 and December 2024 were enrolled in this study. Based on the presence of postoperative UTI, patients were categorized into the UTI group (n=41) and the Non-UTI group (n=89). The mean age of patients in the UTI group was 52.76±8.49 years, comprising 24 males and 17 females, whereas the Non-UTI group had a mean age of 53.03±7.12 years, including 43 males and 46 females.
Who may be able to join
- Age ≥18 years;
- Diagnosis of urinary calculi confirmed by CT, X-ray, or ultrasound;
- Complete clinical data available. -
Who cannot join
- Presence of active UTI or other infections prior to surgery;
- Coexisting urological disorders (e.g., bladder cancer, neurogenic bladder);
- Prolonged use of immunosuppressants or antibiotics (>2 weeks). -
Trial locations and contacts
1 site in 1 country.
China1 site
Suzhou Hospital of Integrated Traditional Chinese and Western Medicine
Suzhou, Jiangsu, 215101
About this study
Official title: Pathogen Resistance Characteristics and Development of a Combined Diagnostic Model Using Hs-CRP, HBP, NGAL, and ADPN for Postoperative Urinary Tract Infections in Patients With Kidney Stones
The combined detection of HBP, ADPN, NGAL, and hs-CRP enables the construction of a highly efficient diagnostic model, offering a novel strategy for early infection identification and risk stratification after surgery.
Read the detailed description
This study investigated pathogen distribution, antimicrobial resistance, and the diagnostic utility of biomarkers (hs-CRP, HBP, NGAL, ADPN) for Urinary Tract Infections (UTI) after kidney stone surgery. A total of 130 patients with kidney stones, treated between February 2021 and December 2024, were included in this study. Based on the occurrence of postoperative UTIs, they were categorized into the UTI group (n=41) and the Non-UTI group (n=89). Laboratory parameters, including WBC, NLR, NEU, hs-CRP, HBP, NGAL, and ADPN levels, were measured. Midstream clean-catch urine samples from patients in the UTI group were collected for pathogen identification and antimicrobial susceptibility testing. Pearson correlation analysis was performed to assess the relationships among these biomarkers, ROC curve analysis was conducted to evaluate diagnostic performance, and logistic regression analysis was used to identify independent risk factors for postoperative infections.
- Being tested
- the UTI group, the Non-UTI group
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the UTI groupOther
Laboratory parameters, including WBC, NLR, NEU, hs-CRP, HBP, NGAL, and ADPN levels, were measured. Midstream clean-catch urine samples from patients in the UTI group were collected for pathogen identification and antimicrobial susceptibility testing.
the Non-UTI groupOther
Laboratory parameters, including WBC, NLR, NEU, hs-CRP, HBP, NGAL, and ADPN levels, were measured. Midstream clean-catch urine samples from patients in the UTI group were collected for pathogen identification and antimicrobial susceptibility testing.
| Study group | Role | What they receive |
|---|---|---|
| the UTI group | Midstream clean-catch urine samples from patients in the UTI group were collected for pathogen identification and antimicrobial susceptibility testing. Receives: Other: the UTI group | |
| the Non-UTI group | Midstream clean-catch urine samples from patients in the UTI group were collected for pathogen identification and antimicrobial susceptibility testing. Receives: Other: the Non-UTI group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathogen Resistance Characteristics and Development of a Combined Diagnostic Model Using hs-CRP, HBP, NGAL, and ADPN for Postoperative Urinary Tract Infections in Patients with Kidney Stones
Postoperative UTI in kidney stone patients are primarily caused by Gram-negative bacteria with high resistance. Combined detection of hs-CRP, HBP, NGAL, and ADPN significantly improves diagnostic accuracy. HBP, NGAL, and ADPN serve as early predictive markers for postoperative infection, providing a reference for clinical practice.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start9 Feb 2021
- Primary completion10 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infection ComplicatedStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xingxin Jiang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Xingxin Jiang, Suzhou Hospital of Integrated Traditional Chinese and Western Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946667
- Sponsor's protocol ID
- No. 2025-008
- Status last verified
- Jan 2025
- First submitted
- 6 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogen Resistance Characteristics and Development of a Combined Diagnostic Model Using Hs-CRP, HBP, NGAL, and ADPN for Postoperative Urinary Tract Infections in Patients With Kidney Stones
- ClinicalTrials.gov ID
- NCT06946667
- Acronym / sponsor ID
- No. 2025-008
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Xingxin JiangOther government
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Apr 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 combined detection of HBP, ADPN, NGAL, and hs-CRP enables the construction of a highly efficient diagnostic model, offering a novel strategy for early infection identification and risk stratification after surgery.
Detailed description
This study investigated pathogen distribution, antimicrobial resistance, and the diagnostic utility of biomarkers (hs-CRP, HBP, NGAL, ADPN) for Urinary Tract Infections (UTI) after kidney stone surgery. A total of 130 patients with kidney stones, treated between February 2021 and December 2024, were included in this study. Based on the occurrence of postoperative UTIs, they were categorized into the UTI group (n=41) and the Non-UTI group (n=89). Laboratory parameters, including WBC, NLR, NEU, hs-CRP, HBP, NGAL, and ADPN levels, were measured. Midstream clean-catch urine samples from patients in the UTI group were collected for pathogen identification and antimicrobial susceptibility testing. Pearson correlation analysis was performed to assess the relationships among these biomarkers, ROC curve analysis was conducted to evaluate diagnostic performance, and logistic regression analysis was used to identify independent risk factors for postoperative infections.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the UTI group | – | Other: the UTI groupMidstream clean-catch urine samples from patients in the UTI group were collected for pathogen identification and antimicrobial susceptibility testing. |
| the Non-UTI group | – | Other: the Non-UTI groupMidstream clean-catch urine samples from patients in the UTI group were collected for pathogen identification and antimicrobial susceptibility testing. |
Who may qualify
- Ages
- 44 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A total of 130 patients diagnosed with kidney stones and treated at our hospital between February 2021 and December 2024 were enrolled in this study. Based on the presence of postoperative UTI, patients were categorized into the UTI group (n=41) and the Non-UTI group (n=89). The mean age of patients in the UTI group was 52.76±8.49 years, comprising 24 males and 17 females, whereas the Non-UTI group had a mean age of 53.03±7.12 years, including 43 males and 46 females.
Key inclusion criteria (3 listed)
- Age ≥18 years;
- Diagnosis of urinary calculi confirmed by CT, X-ray, or ultrasound;
- Complete clinical data available. -
Key exclusion criteria (3 listed)
- Presence of active UTI or other infections prior to surgery;
- Coexisting urological disorders (e.g., bladder cancer, neurogenic bladder);
- Prolonged use of immunosuppressants or antibiotics (>2 weeks). -
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 |
|---|---|---|
| the UTI groupLaboratory parameters, including WBC, NLR, NEU, hs-CRP, HBP, NGAL, and ADPN levels, were measured. Midstream clean-catch urine samples from patients in the UTI group were collected for pathogen identification and antimicrobial susceptibility testing. | Other | the UTI group |
| the Non-UTI groupLaboratory parameters, including WBC, NLR, NEU, hs-CRP, HBP, NGAL, and ADPN levels, were measured. Midstream clean-catch urine samples from patients in the UTI group were collected for pathogen identification and antimicrobial susceptibility testing. | Other | the Non-UTI group |
Primary outcome
Pathogen Resistance Characteristics and Development of a Combined Diagnostic Model Using hs-CRP, HBP, NGAL, and ADPN for Postoperative Urinary Tract Infections in Patients with Kidney Stones
Time frame: 10 weeks
Postoperative UTI in kidney stone patients are primarily caused by Gram-negative bacteria with high resistance. Combined detection of hs-CRP, HBP, NGAL, and ADPN significantly improves diagnostic accuracy. HBP, NGAL, and ADPN serve as early predictive markers for postoperative infection, providing a reference for clinical practice.
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 27 Apr 2025.
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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?
An observational study of Urinary Tract Infection Complicated and Kidney Stones, run by Xingxin Jiang at 1 site in China.
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 3 inclusion and 3 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 27 Apr 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 China. 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?
Pathogen Resistance Characteristics and Development of a Combined Diagnostic Model Using hs-CRP, HBP, NGAL, and ADPN for Postoperative Urinary Tract Infections in Patients with Kidney Stones (time frame: 10 weeks). 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 27 Apr 2025.