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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

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.

Italy1 site

IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, 37024

Other trials in Italy

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.

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 groups in NCT06308705
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.

6 Jun 202318 Oct 2023

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluation of the Rapid Diagnostic Test SsRT+ for Strongyloides Stercoralis
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