PyelonephritisNCT06802796
Plasma NGAL in APN Patients
An observational study of Pyelonephritis, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
In recent years, novel biomarkers of renal dysfunction have attracted attention for the diagnosis of UTIs. NGAL is a 25 kDa protein that belongs to the lipocalin. It acts as a transporter for small hydrophobic molecules and is involved in many physiological processes, such as modulating inflammation, innate immune… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pyelonephritis
- What is being tested?
- Plasma NGAL test
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Jun 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patient had fever due to renal infection
Who may be able to join
- above 20 years Suspected have pyelonphirtis
Who cannot join
- age below 20
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasma NGAL as a Predictor to Acute Pyelonephritis : Case -Control Cohort Study .
In recent years, novel biomarkers of renal dysfunction have attracted attention for the diagnosis of UTIs. NGAL is a 25 kDa protein that belongs to the lipocalin. It acts as a transporter for small hydrophobic molecules and is involved in many physiological processes, such as modulating inflammation, innate immune response, and maintaining metabolic homeostasis
- Conditions
- Pyelonephritis
- Being tested
- Plasma NGAL test
- Medical subject headings
- Pyelonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma NGAL testDiagnostic test
Human neutrophil gelatinase-associated lipocalin ELISA Kit from BT LAB® Bioassay technology laboratory was used for the estimation of serum NGAL. Procedure was done according to the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Group A :patient with pyelonephritis | patient with pyelonephritis Receives: Diagnostic Test: Plasma NGAL test | |
| Group B :patient without pyelonephritis | patient without pyelonephritis Receives: Diagnostic Test: Plasma NGAL test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Result of plasma NGAL test
Result of serum test of NGAL
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Feb 2024
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PyelonephritisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsayed Abdelhalim Elsayed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802796
- Sponsor's protocol ID
- KFSIRB200-143
- Status last verified
- Jan 2025
- First submitted
- 25 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma NGAL as a Predictor to Acute Pyelonephritis : Case -Control Cohort Study .
- ClinicalTrials.gov ID
- NCT06802796
- Acronym / sponsor ID
- KFSIRB200-143
- Conditions
- Pyelonephritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 31 Jan 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.
In recent years, novel biomarkers of renal dysfunction have attracted attention for the diagnosis of UTIs. NGAL is a 25 kDa protein that belongs to the lipocalin. It acts as a transporter for small hydrophobic molecules and is involved in many physiological processes, such as modulating inflammation, innate immune response, and maintaining metabolic homeostasis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A :patient with pyelonephritis | – | Diagnostic Test: Plasma NGAL testpatient with pyelonephritis |
| Group B :patient without pyelonephritis | – | Diagnostic Test: Plasma NGAL testpatient without pyelonephritis |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patient had fever due to renal infection
Key inclusion criteria (1 listed)
- above 20 years Suspected have pyelonphirtis
Key exclusion criteria (1 listed)
- age below 20
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 |
|---|---|---|
| Plasma NGAL testHuman neutrophil gelatinase-associated lipocalin ELISA Kit from BT LAB® Bioassay technology laboratory was used for the estimation of serum NGAL. Procedure was done according to the manufacturer's instructions. | Diagnostic test | Group A :patient with pyelonephritis, Group B :patient without pyelonephritis |
Primary outcome
Result of plasma NGAL test
Time frame: One day
Result of serum test of NGAL
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 31 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Pyelonephritis
Not yet recruitingPhase 2
This is a Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ertapenem-zidebactam Versus Ceftazidime-Avibactam in the Treatment of Hospitalized Adult Patients With Complicated Urinary Tract Infection or Acute Pyelonephritis
Complicated Urinary Tract Infections(cUTI), Acute Pyelonephritis
Not yet recruitingObservational study
Real-World Study of Obstructive Upper Urinary Tract Stones and Acute Pyelonephritis
Urolithiasis, Strategy Training
Active, not recruitingPhase 2
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
Acute Pyelonephritis, Complicated Urinary Tract Infection
RecruitingObservational study
Diagnosis of Abdominal Pain Using RNA Levels: The NATURAL Study
Intra Abdominal Infections, Appendicitis Acute
RecruitingPhase 4
3-day IV Antibiotic Treatment Versus 3-day IV Followed by 7-day Oral Antibiotic Treatment for AP in Children
Pyelonephritis Acute
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 Pyelonephritis, run by Kafrelsheikh 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 1 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 31 Jan 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?
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?
Result of plasma NGAL test (time frame: One day). 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 31 Jan 2025; AzTrials last refreshed its copy on 31 Oct 2026.