Peritoneal Dialysis-associated PeritonitisNCT05450523
Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) Clinical Trial Protocol
An observational study of Peritoneal Dialysis-associated Peritonitis, run by Qingdao HIGHTOP Biotech Co., Ltd. at 1 site in China.
Trial summary
According to the requirements of the "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents", the first registered product (hereinafter referred to as the assessment reagent) - Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) was tested in clinical institutions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peritoneal Dialysis-associated Peritonitis
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2021to 7 Sep 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with peritoneal dialysis due to kidney disease, including those with confirmed peritonitis and those without peritonitis.
Who may be able to join
- Patients treated with peritoneal dialysis due to kidney disease, including those with confirmed peritonitis and those without peritonitis. There are no age or gender requirements, and informed consent is required.
Who cannot join
- Patients who have been treated with antibiotics for peritonitis before taking the sample.
- Incomplete information, including: sample ID number, gender, age, department, clinical diagnosis, sample type, and sampling date.
- The sample size is insufficient.
- Repeated cases.
- The samples whose permeate is red in visual inspection.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hosital of Nangchang university
Nanchang, Jiangxi
About this study
Official title: Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold)
According to the requirements of the "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents", the first registered product (hereinafter referred to as the assessment reagent) - Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) was tested in clinical institutions. ) for clinical validation trials. Prove that the clinical performance of the assessment reagent meets the requirements of the intended use.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment reagent test results and clinical reference standard statistics
The peritoneal dialysis effluent collected from the subjects was tested blindly with the assessment reagents, and the test results were compared with the clinical reference standards. By evaluating the clinical sensitivity and specificity of the assessment reagents, the feasibility of clinical application of the assessment reagents was evaluated.
Measured: 8 months
Statistical analysis of non-professional self-testing test
There is no need to train non-professionals. After reading the instructions and labels, non-professionals can evaluate their ability to understand key information such as instructions and packaging labels through questionnaires; Research, comparison of test results of different forms of reagents, and comparison with professional test results to evaluate their operational capabilities.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start28 Dec 2021
- Primary completion7 Sep 2022
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis-associated PeritonitisStudies 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qingdao HIGHTOP Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qinkai Chen, Chief physician, Study chair, The first affiliated hosital of Nangchang university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450523
- Sponsor's protocol ID
- HT1.0
- Status last verified
- Mar 2023
- First submitted
- 27 Jun 2022
- Last updated
- 21 Mar 2023
- 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 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold)
- ClinicalTrials.gov ID
- NCT05450523
- Acronym / sponsor ID
- HT1.0
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Qingdao HIGHTOP Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 8 Jul 2022 (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.
According to the requirements of the "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents", the first registered product (hereinafter referred to as the assessment reagent) - Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) was tested in clinical institutions. ) for clinical validation trials. Prove that the clinical performance of the assessment reagent meets the requirements of the intended use.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with peritoneal dialysis due to kidney disease, including those with confirmed peritonitis and those without peritonitis.
Key inclusion criteria (1 listed)
- Patients treated with peritoneal dialysis due to kidney disease, including those with confirmed peritonitis and those without peritonitis. There are no age or gender requirements, and informed consent is required.
Key exclusion criteria (5 listed)
- Patients who have been treated with antibiotics for peritonitis before taking the sample.
- Incomplete information, including: sample ID number, gender, age, department, clinical diagnosis, sample type, and sampling date.
- The sample size is insufficient.
- Repeated cases.
- The samples whose permeate is red in visual inspection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment reagent test results and clinical reference standard statistics
Time frame: 8 months
The peritoneal dialysis effluent collected from the subjects was tested blindly with the assessment reagents, and the test results were compared with the clinical reference standards. By evaluating the clinical sensitivity and specificity of the assessment reagents, the feasibility of clinical application of the assessment reagents was evaluated.
Statistical analysis of non-professional self-testing test
Time frame: 8 months
There is no need to train non-professionals. After reading the instructions and labels, non-professionals can evaluate their ability to understand key information such as instructions and packaging labels through questionnaires; Research, comparison of test results of different forms of reagents, and comparison with professional test results to evaluate their operational capabilities.
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 21 Mar 2023.
Related trials for Peritoneal Dialysis-associated Peritonitis
RecruitingObservational study
Peritoneal Dialysis Registration System (PERSIST)
ESRD, Disorders Associated With Peritoneal Dialysis
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.
Qinkai Chen, Chief physician study chair
The first affiliated hosital of Nangchang university
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 Peritoneal Dialysis-associated Peritonitis, run by Qingdao HIGHTOP Biotech Co., Ltd. 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 1 inclusion and 5 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 21 Mar 2023. 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?
Assessment reagent test results and clinical reference standard statistics (time frame: 8 months). 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 21 Mar 2023.