Strongyloides Stercoralis InfectionNCT07876622
Evaluation of the Rapid Diagnostic Test SsRT+ for Strongyloides Stercoralis
A study testing Analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid) in people with Strongyloides Stercoralis Infection and Device Performance, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial summary
The goal of this performance study is to determine if the diagnostic accuracy of the SsRT+ for the diagnosis of S. stercoralis infection meets the minimum requirements defined in the WHO target product profile. The study does not involve patients, but rather the analysis of samples stored in the local biobank. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Strongyloides Stercoralis Infection, Device Performance, Diagnostic
- What is being tested?
- Analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 1 siteItaly
- Study dates
- 2 Oct 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Serum from individuals who were prescribed screening tests for S. stercoralis
- Written consent to the donation of the leftover sample to the local biobank
Who cannot join
- Unavailable/insufficient quantity of serum
- Serum from individuals who received treatment with ivermectin in the previous 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Diagnostic Performance of SsRT+, a Novel Rapid Diagnostic Test for Strongyloides Stercoralis (Strongyloides RT)
The goal of this performance study is to determine if the diagnostic accuracy of the SsRT+ for the diagnosis of S. stercoralis infection meets the minimum requirements defined in the WHO target product profile.
The study does not involve patients, but rather the analysis of samples stored in the local biobank.
Read the detailed description
This is a performance study with In-vitro diagnostic device on sera available in the local biobank. The study device SsRT+ is a lateral flow assay in a cassette format, detecting human IgG4 against the Strongyloides stercoralis antigen. The study involves the analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid). Two independent readers will report the results of both Rapid Diagnostic Tests (RTDs) blinded from each other. In case of discrepancies, a third reader will be involved. The results will be compared with the already available results from serological (i.e., an in-house Immunofluorescent Antibody Test [IFAT] and a commercial ELISA) and fecal (i.e., copromicroscopy after formol-ether concentration, Agar Plate Culture [APC] and Polymerase Chain Reaction [PCR]) routine diagnostic tests for S.stercoralis will be retrieved from the patients' records.
- Being tested
- Analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid)
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid)Diagnostic test
Analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid). Two independent readers will report the results of both Rapid Diagnostic Tests (RTDs) blinded from each other. In case of discrepancies, a third reader will be involved. The results will be compared with the already available results from serological (i.e., an in-house Immunofluorescent Antibody Test [IFAT] and a commercial ELISA) and fecal (i.e., copromicroscopy after formol-ether concentration, Agar Plate Culture [APC] and Polymerase Chain Reaction [PCR]) routine diagnostic tests for S.stercoralis will be retrieved from the patients' records.
| Study group | Role | What they receive |
|---|---|---|
| Analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid) | Experimental | Not described Receives: Diagnostic Test: Analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the SsRT+ test
Measured: 6 weeks from Baseline
Secondary outcomes (1)
Sensitivity and specificity of the of the prototype SsRapid test
Measured: 6 weeks from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start2 Oct 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 780 participants (estimated)
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
- NCT07876622
- Sponsor's protocol ID
- 2026-36
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Performance of SsRT+, a Novel Rapid Diagnostic Test for Strongyloides Stercoralis (Strongyloides RT)
- ClinicalTrials.gov ID
- NCT07876622
- Acronym / sponsor ID
- 2026-36
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 2 Oct 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Oct 2026 (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.
The goal of this performance study is to determine if the diagnostic accuracy of the SsRT+ for the diagnosis of S. stercoralis infection meets the minimum requirements defined in the WHO target product profile.
The study does not involve patients, but rather the analysis of samples stored in the local biobank.
Detailed description
This is a performance study with In-vitro diagnostic device on sera available in the local biobank. The study device SsRT+ is a lateral flow assay in a cassette format, detecting human IgG4 against the Strongyloides stercoralis antigen. The study involves the analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid). Two independent readers will report the results of both Rapid Diagnostic Tests (RTDs) blinded from each other. In case of discrepancies, a third reader will be involved. The results will be compared with the already available results from serological (i.e., an in-house Immunofluorescent Antibody Test [IFAT] and a commercial ELISA) and fecal (i.e., copromicroscopy after formol-ether concentration, Agar Plate Culture [APC] and Polymerase Chain Reaction [PCR]) routine diagnostic tests for S.stercoralis will be retrieved from the patients' records.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid) | Experimental | Diagnostic Test: Analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Serum from individuals who were prescribed screening tests for S. stercoralis
- Written consent to the donation of the leftover sample to the local biobank
Key exclusion criteria (2 listed)
- Unavailable/insufficient quantity of serum
- Serum from individuals who received treatment with ivermectin in the previous 6 months
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 |
|---|---|---|
| Analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid)Analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid). Two independent readers will report the results of both Rapid Diagnostic Tests (RTDs) blinded from each other. In case of discrepancies, a third reader will be involved. The results will be compared with the already available results from serological (i.e., an in-house Immunofluorescent Antibody Test [IFAT] and a commercial ELISA) and fecal (i.e., copromicroscopy after formol-ether concentration, Agar Plate Culture [APC] and Polymerase Chain Reaction [PCR]) routine diagnostic tests for S.stercoralis will be retrieved from the patients' records. | Diagnostic test | Analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid) |
Primary outcome
Sensitivity and specificity of the SsRT+ test
Time frame: 6 weeks from Baseline
1 secondary outcome
Sensitivity and specificity of the of the prototype SsRapid test
Time frame: 6 weeks from Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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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 Analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid) in people with Strongyloides Stercoralis Infection and Device Performance, 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 2 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Sensitivity and specificity of the SsRT+ test (time frame: 6 weeks from Baseline). 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 15 Oct 2026.