Strongyloides Stercoralis InfectionPROTOSSNCT06368609
Preliminary Evaluation of Two Rapid Diagnostic Test Prototypes for Strongyloides Stercoralis Infection
A study testing IgG RDT and IgG4 RDT in people with Strongyloides Stercoralis Infection, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial summary
Single center, no profit experimental study on sera available in the Tropica Biobank. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Strongyloides Stercoralis Infection
- What is being tested?
- IgG RDT and IgG4 RDT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2024to May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Serum from immigrants from S. stercoralis endemic countries (i.e. individuals from Africa, Latin America, South-East Asia and western Pacific regions);
- Serum with a matched result of APC and/or PCR for S. stercoralis (i.e. the latter test/s done in the same day or ±30 days from the collection of the serum) and of serology assays (IFAT and/or ELISA) in use in our laboratory.
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.
Italy1 site
IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, 37024
Dora Buonfrate, dora.buonfrate@sacrocuore.it
Dora Buonfrate
About this study
Single center, no profit experimental study on sera available in the Tropica Biobank.
- Conditions
- Strongyloides Stercoralis Infection
- Being tested
- IgG RDT, IgG4 RDT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgG RDTDiagnostic test
Sera will be thawed at room temperature; 15 µL of serum will be added to the sample pad of each dipstick, which will then be placed upright into a well containing 3 drops of buffer. The pads at the bottom of the dipstick shall then wick up the buffer to run up the nitrocellulose membrane towards the absorbent pad. The results can be read after 15-20 minutes. The presence of the control line will indicate proper execution of the test, with valid result. In case of absence of this line, the result will be considered invalid. Positive results will be defined as test with presence of both control and positive (including faint) lines; negative results will be defined as tests with presence of control line only.
IgG4 RDTDiagnostic test
Sera will be thawed at room temperature; 15 µL of serum will be added to the sample pad of each dipstick, which will then be placed upright into a well containing 3 drops of buffer. The pads at the bottom of the dipstick shall then wick up the buffer to run up the nitrocellulose membrane towards the absorbent pad. The results can be read after 15-20 minutes. The presence of the control line will indicate proper execution of the test, with valid result. In case of absence of this line, the result will be considered invalid. Positive results will be defined as test with presence of both control and positive (including faint) lines; negative results will be defined as tests with presence of control line only.
| Study group | Role | What they receive |
|---|---|---|
| RDT (Rapid Diagnostic Test) arm | Other | The sera will be selected from the database of the Tropica biobank, based on the given exclusion/inclusion criteria.
The samples will be tested after thawing shortly before the procedures. Each serum sample will be used for running the two RDTs (IgG and IgG4). Two independent readers will report the test results blinded from each other. In case of discrepancies, a third reader will be involved. Receives: Diagnostic Test: IgG RDT; Diagnostic Test: IgG4 RDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
RDTs IgG results: positive or negative
RDTs (IgG) results will be classified as positive or negative according to the manufacturer instructions. For the composite reference standard definition: a true positive will be defined as at least one positive faecal test result. True negative will be defined as all test results (faecal and serological) being negative.
Measured: baseline
RDTs IgG4 results: positive or negative
RDTs (IgG4) results will be classified as positive or negative according to the manufacturer instructions. For the composite reference standard definition: a true positive will be defined as at least one positive faecal test result. True negative will be defined as all test results (faecal and serological) being negative.
Measured: baseline
Secondary outcomes (1)
Agreement between readers
Agreement between two independent readers of the RDTs results
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (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
- 100 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
- NCT06368609
- Sponsor's protocol ID
- 2024-09
- Acronym
- PROTOSS
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 18 Apr 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 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Evaluation of Two Rapid Diagnostic Test Prototypes for Strongyloides Stercoralis Infection
- ClinicalTrials.gov ID
- NCT06368609
- Acronym / sponsor ID
- PROTOSS / 2024-09
- Conditions
- Strongyloides Stercoralis Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 16 Apr 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.
Single center, no profit experimental study on sera available in the Tropica Biobank.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RDT (Rapid Diagnostic Test) arm | Other | Diagnostic Test: IgG RDT, Diagnostic Test: IgG4 RDTThe sera will be selected from the database of the Tropica biobank, based on the given exclusion/inclusion criteria. The samples will be tested after thawing shortly before the procedures. Each serum sample will be used for running the two RDTs (IgG and IgG4). Two independent readers will report the test results blinded from each other. In case of discrepancies, a third reader will be involved. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Serum from immigrants from S. stercoralis endemic countries (i.e. individuals from Africa, Latin America, South-East Asia and western Pacific regions);
- Serum with a matched result of APC and/or PCR for S. stercoralis (i.e. the latter test/s done in the same day or ±30 days from the collection of the serum) and of serology assays (IFAT and/or ELISA) in use in our laboratory.
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 |
|---|---|---|
| IgG RDTSera will be thawed at room temperature; 15 µL of serum will be added to the sample pad of each dipstick, which will then be placed upright into a well containing 3 drops of buffer. The pads at the bottom of the dipstick shall then wick up the buffer to run up the nitrocellulose membrane towards the absorbent pad. The results can be read after 15-20 minutes. The presence of the control line will indicate proper execution of the test, with valid result. In case of absence of this line, the result will be considered invalid. Positive results will be defined as test with presence of both control and positive (including faint) lines; negative results will be defined as tests with presence of control line only. | Diagnostic test | RDT (Rapid Diagnostic Test) arm |
| IgG4 RDTSera will be thawed at room temperature; 15 µL of serum will be added to the sample pad of each dipstick, which will then be placed upright into a well containing 3 drops of buffer. The pads at the bottom of the dipstick shall then wick up the buffer to run up the nitrocellulose membrane towards the absorbent pad. The results can be read after 15-20 minutes. The presence of the control line will indicate proper execution of the test, with valid result. In case of absence of this line, the result will be considered invalid. Positive results will be defined as test with presence of both control and positive (including faint) lines; negative results will be defined as tests with presence of control line only. | Diagnostic test | RDT (Rapid Diagnostic Test) arm |
Primary outcome
RDTs IgG results: positive or negative
Time frame: baseline
RDTs (IgG) results will be classified as positive or negative according to the manufacturer instructions. For the composite reference standard definition: a true positive will be defined as at least one positive faecal test result. True negative will be defined as all test results (faecal and serological) being negative.
RDTs IgG4 results: positive or negative
Time frame: baseline
RDTs (IgG4) results will be classified as positive or negative according to the manufacturer instructions. For the composite reference standard definition: a true positive will be defined as at least one positive faecal test result. True negative will be defined as all test results (faecal and serological) being negative.
1 secondary outcome
Agreement between readers
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IgG RDT and IgG4 RDT 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 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: status not confirmed, as of the sponsor's last update on 18 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elvia Malo (+390456014854, ricerca.clinica@sacrocuore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RDTs IgG results: positive or negative (time frame: baseline). 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 18 Apr 2024.