PeritonitisPeriplexNCT04070196
Point-of-care Test for Diagnosis of Peritonitis in Peritoneal Dialysis Patients
A study testing Periplex in people with Peritonitis, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Peritoneal dialysis (PD) is a home-based dialysis therapy and peritonitis is a serious complication in PD. A reliable point-of-care test to detect peritonitis is important for patients to self-detect peritonitis at home as delayed diagnosis and treatment of peritonitis will translate to poor outcomes in PD patients. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Peritonitis
- What is being tested?
- Periplex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSingapore
- Study dates
- 25 Sep 2019to 24 Feb 2024
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult PD patients who are followed up in Singapore General Hospital and presented with signs and symptoms suspected of peritonitis including fever, abdominal pain or cloudy effluent will be recruited for the study.
Who cannot join
- 1. PD patients who are not followed up in SGH 2. Patients with mentally challenging conditions and who are unable to provide a valid consent 3. Non-PD patients 4. PD patients who do not have signs or symptoms suspected of peritonitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Point-of-care Test for Diagnosis of Peritonitis in Peritoneal Dialysis Patients
Peritoneal dialysis (PD) is a home-based dialysis therapy and peritonitis is a serious complication in PD. A reliable point-of-care test to detect peritonitis is important for patients to self-detect peritonitis at home as delayed diagnosis and treatment of peritonitis will translate to poor outcomes in PD patients. The study aims to examine the effectiveness of Periplex®, point-of-care test, in the diagnosis of peritonitis in PD patients.
Read the detailed description
A reliable point-of-care test to detect peritonitis is indeed needed for early diagnosis of peritonitis at home and seeking medical help early.
We hypothesize that Periplex® is not inferior to routine leukocyte testing of PD Fluid effluent in the diagnosis of peritonitis. The test strip is designed to detect the inflammatory markers (IL6 and MMP-8) which are usually released during peritonitis. The strip is intended to be used in the PD patients who suspected to have symptoms of peritonitis. The target population is all adult PD patients who are followed up in Singapore General Hospital and have signs and symptoms suspected of peritonitis during the study period. The test is considered positive for peritonitis if one or both test lines appear in the window of the test strip.
The test will be performed at 2-time points, one at the presentation of peritonitis and one at the completion of antibiotics for the current episode of peritonitis, to document resolution of peritonitis.
The results of the tests will be compared with the leukocyte testing of PD effluent.
- Conditions
- Peritonitis
- Being tested
- Periplex
- Keywords
- Peritonitis, point-of-care test, Peritoneal Dialysis
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeriplexDiagnostic test
Periplex test strip will be used to examine the PD effluent for peritonitis, in addition to the routine leucocyte testing of PD effluent
| Study group | Role | What they receive |
|---|---|---|
| Leucocyte testing | Other | The PD effluent will be sent to the laboratory for leucocyte testing for patients presented with suspected PD peritonitis. Receives: Diagnostic Test: Periplex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test positive for peritonitis
Number of participants having positive test result for peritonitis
Measured: within 24 hours of presentation with signs and symptoms suspected of peritonitis in PD patients.
Secondary outcomes (2)
resolution of peritonitis
Number of participants having negative test result for peritonitis
Measured: within 2 weeks of completion of a course of antibiotics for peritonitis
causal organisms for peritonitis
Number of participants with gram-positive organisms, gram-negative organisms, no bacterial growth or other organisms peritonitis having test result positive for peritonitis
Measured: within a week of peritonitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start25 Sep 2019
- Primary completion24 Jun 2023
- Study completion24 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mologic Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070196
- Sponsor's protocol ID
- 2018/3152
- Acronym
- Periplex
- Status last verified
- Apr 2024
- First submitted
- 18 Aug 2019
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Point-of-care Test for Diagnosis of Peritonitis in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT04070196
- Acronym / sponsor ID
- Periplex / 2018/3152
- Conditions
- Peritonitis
- Keywords
- Peritonitis, point-of-care test, Peritoneal Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Mologic Ltd
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 24 Jun 2023 (actual)
- Study completion
- 24 Feb 2024 (actual)
- First posted
- 28 Aug 2019 (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.
Peritoneal dialysis (PD) is a home-based dialysis therapy and peritonitis is a serious complication in PD. A reliable point-of-care test to detect peritonitis is important for patients to self-detect peritonitis at home as delayed diagnosis and treatment of peritonitis will translate to poor outcomes in PD patients. The study aims to examine the effectiveness of Periplex®, point-of-care test, in the diagnosis of peritonitis in PD patients.
Detailed description
A reliable point-of-care test to detect peritonitis is indeed needed for early diagnosis of peritonitis at home and seeking medical help early.
We hypothesize that Periplex® is not inferior to routine leukocyte testing of PD Fluid effluent in the diagnosis of peritonitis. The test strip is designed to detect the inflammatory markers (IL6 and MMP-8) which are usually released during peritonitis. The strip is intended to be used in the PD patients who suspected to have symptoms of peritonitis. The target population is all adult PD patients who are followed up in Singapore General Hospital and have signs and symptoms suspected of peritonitis during the study period. The test is considered positive for peritonitis if one or both test lines appear in the window of the test strip.
The test will be performed at 2-time points, one at the presentation of peritonitis and one at the completion of antibiotics for the current episode of peritonitis, to document resolution of peritonitis.
The results of the tests will be compared with the leukocyte testing of PD effluent.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Leucocyte testing | Other | Diagnostic Test: PeriplexThe PD effluent will be sent to the laboratory for leucocyte testing for patients presented with suspected PD peritonitis. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult PD patients who are followed up in Singapore General Hospital and presented with signs and symptoms suspected of peritonitis including fever, abdominal pain or cloudy effluent will be recruited for the study.
Key exclusion criteria (1 listed)
- 1. PD patients who are not followed up in SGH 2. Patients with mentally challenging conditions and who are unable to provide a valid consent 3. Non-PD patients 4. PD patients who do not have signs or symptoms suspected of peritonitis
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 |
|---|---|---|
| PeriplexPeriplex test strip will be used to examine the PD effluent for peritonitis, in addition to the routine leucocyte testing of PD effluent | Diagnostic test | Leucocyte testing |
Primary outcome
Test positive for peritonitis
Time frame: within 24 hours of presentation with signs and symptoms suspected of peritonitis in PD patients.
Number of participants having positive test result for peritonitis
2 secondary outcomes
resolution of peritonitis
Time frame: within 2 weeks of completion of a course of antibiotics for peritonitis
causal organisms for peritonitis
Time frame: within a week of peritonitis
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 1 May 2024.
Related trials for Peritonitis
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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 Periplex in people with Peritonitis, run by Singapore General Hospital at 1 site in Singapore.
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 1 May 2024. 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 Singapore. 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?
Test positive for peritonitis (time frame: within 24 hours of presentation with signs and symptoms suspected of peritonitis in PD patients.). 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 1 May 2024.