Strongyloides Stercoralis InfectionNCT06308705
The SsRI/NIE Recombinant Antigen ELISA for the Follow up of Patients Infected by Strongyloides Stercoralis
A study testing InBios Strongy Detect TM IgG ELISA in people with Strongyloides Stercoralis Infection, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial summary
This is a single-center interventional study with an IVD medical device. The main objective of this study is to evaluate the ELISA SsIR/NIE test for the post-treatment follow-up of patients suffering from strongyloidosis, using well-characterized sera from a previous study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Strongyloides Stercoralis Infection
- What is being tested?
- InBios Strongy Detect TM IgG ELISA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jun 2023to 18 Oct 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All sera available in our biobank and originating from the Strong Treat trial
- availability of the baseline and the 12-month follow up serum of each included case
Who cannot join
- unavailability of the baseline or of the 12-month follow up serum of each included case
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-center interventional study with an IVD medical device.
The main objective of this study is to evaluate the ELISA SsIR/NIE test for the post-treatment follow-up of patients suffering from strongyloidosis, using well-characterized sera from a previous study.
Read more
All sera available in the Tropica biobank and coming from the Strong Treat study, for which serum samples collected at baseline and at 12-month follow-up are available, will be eligible for the study.
The test The InBios Strongy Detect TM IgG ELISA detects specific IgG antibodies against recombinant Strongyloides NIE and SsIR antigens in serum. It consists of an enzymatically amplified sandwich immunoassay. Positive and negative control samples are provided in the kit. The test will be performed and interpreted according to the manufacturer's instructions. The results are expressed as OD and nOD. Clinical interpretation of the results will be performed by receiver operating characteristic (ROC) curve analysis generated using data from confirmed positive and confirmed negative samples.
The laboratory technicians will receive from the PI of the study a list of pseudo-anonymized sera to be tested with SsIR/NIE ELISA, they will check their availability and proceed with the test according to the Manufacturer's instructions. Laboratory personnel performing and reading the tests will be blinded to the results of any previously performed tests (and the classification of the sample in the Strong Treat study). A single run will be performed for each sample, unless the test needs to be repeated due to any technical problem. Both baseline and follow-up sera will be tested. The resulting OD and nOD will be reported in an Excel file by the laboratory technicians performing the tests.
- Conditions
- Strongyloides Stercoralis Infection
- Being tested
- InBios Strongy Detect TM IgG ELISA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InBios Strongy Detect TM IgG ELISADiagnostic test
The InBios Strongy Detect TM IgG ELISA detects specific IgG antibodies to Strongyloides recombinant antigens NIE and SsIR in serum. It consists of an enzymatically amplified sandwich-type immunoassay. Positive and negative control samples are provided in the kit. The test will be run and interpreted according to the manufacturer's instruction. The results are expressed as OD and nOD. Clinical interpretation of the results will be done by analysis of the Receiver Operating Characteristics (ROC) curve generated using data from confirmed positive and confirmed negative samples.
| Study group | Role | What they receive |
|---|---|---|
| Sera | Other | All sera available in our biobank and originating from the Strong Treat trial will be eligible for the study, based on the availability of the baseline and the 12-month follow up serum of each included case. Receives: Diagnostic Test: InBios Strongy Detect TM IgG ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Result of the SsIR/NIE ELISA
For each sample, the result of the SsIR/NIE ELISA will be compared with the outcome category (cure/persistence of infection) defined at the 12-month follow up within the Strong Treat study. Similarly to what is established with other serology tests, SsIR/NIE ELISA will indicate parasitological cure when at least a twofold reduction of nOD at the 12-month follow up, compared to the baseline nOD, will be observed.
Measured: Baseline and at the 12-month follow-up
Secondary outcomes (1)
Seroconversion
Proportion of SsIR/NIE ELISA tests showing complete seroreversion within the subgroup of cases that will be correctly (in comparison with the Strong Treat category) classified as cured by the SsIR/NIE ELISA.
Measured: Baseline and at the 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start6 Jun 2023
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strongyloides Stercoralis InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308705
- Sponsor's protocol ID
- 2022-19
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 13 Mar 2024
- 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 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SsRI/NIE Recombinant Antigen ELISA for the Follow up of Patients Infected by Strongyloides Stercoralis
- ClinicalTrials.gov ID
- NCT06308705
- Acronym / sponsor ID
- 2022-19
- Conditions
- Strongyloides Stercoralis Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 13 Mar 2024 (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.
This is a single-center interventional study with an IVD medical device.
The main objective of this study is to evaluate the ELISA SsIR/NIE test for the post-treatment follow-up of patients suffering from strongyloidosis, using well-characterized sera from a previous study.
All sera available in the Tropica biobank and coming from the Strong Treat study, for which serum samples collected at baseline and at 12-month follow-up are available, will be eligible for the study.
The test The InBios Strongy Detect TM IgG ELISA detects specific IgG antibodies against recombinant Strongyloides NIE and SsIR antigens in serum. It consists of an enzymatically amplified sandwich immunoassay. Positive and negative control samples are provided in the kit. The test will be performed and interpreted according to the manufacturer's instructions. The results are expressed as OD and nOD. Clinical interpretation of the results will be performed by receiver operating characteristic (ROC) curve analysis generated using data from confirmed positive and confirmed negative samples.
The laboratory technicians will receive from the PI of the study a list of pseudo-anonymized sera to be tested with SsIR/NIE ELISA, they will check their availability and proceed with the test according to the Manufacturer's instructions. Laboratory personnel performing and reading the tests will be blinded to the results of any previously performed tests (and the classification of the sample in the Strong Treat study). A single run will be performed for each sample, unless the test needs to be repeated due to any technical problem. Both baseline and follow-up sera will be tested. The resulting OD and nOD will be reported in an Excel file by the laboratory technicians performing the tests.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sera | Other | Diagnostic Test: InBios Strongy Detect TM IgG ELISAAll sera available in our biobank and originating from the Strong Treat trial will be eligible for the study, based on the availability of the baseline and the 12-month follow up serum of each included case. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All sera available in our biobank and originating from the Strong Treat trial
- availability of the baseline and the 12-month follow up serum of each included case
Key exclusion criteria (1 listed)
- unavailability of the baseline or of the 12-month follow up serum of each included case
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 |
|---|---|---|
| InBios Strongy Detect TM IgG ELISAThe InBios Strongy Detect TM IgG ELISA detects specific IgG antibodies to Strongyloides recombinant antigens NIE and SsIR in serum. It consists of an enzymatically amplified sandwich-type immunoassay. Positive and negative control samples are provided in the kit. The test will be run and interpreted according to the manufacturer's instruction. The results are expressed as OD and nOD. Clinical interpretation of the results will be done by analysis of the Receiver Operating Characteristics (ROC) curve generated using data from confirmed positive and confirmed negative samples. | Diagnostic test | Sera |
Primary outcome
Result of the SsIR/NIE ELISA
Time frame: Baseline and at the 12-month follow-up
For each sample, the result of the SsIR/NIE ELISA will be compared with the outcome category (cure/persistence of infection) defined at the 12-month follow up within the Strong Treat study. Similarly to what is established with other serology tests, SsIR/NIE ELISA will indicate parasitological cure when at least a twofold reduction of nOD at the 12-month follow up, compared to the baseline nOD, will be observed.
1 secondary outcome
Seroconversion
Time frame: Baseline and at the 12-month follow-up
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 13 Mar 2024.
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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 InBios Strongy Detect TM IgG ELISA in people with Strongyloides Stercoralis Infection, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
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 2 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 13 Mar 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 Italy. 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 the SsIR/NIE ELISA (time frame: Baseline and at the 12-month follow-up). 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 13 Mar 2024.