Schistosomiasis
Conditions
Keywords
schistosomiasis, chronic, diagnosis
Brief summary
The primary objective of this clinical investigation is to determine the percentage of travelers and migrants diagnosed with chronic schistosomiasis according to site-specific diagnostic practice who have active infection at the time of evaluation (as assessed and classified by composite reference standards that integrate clinical, laboratory, and diagnostic features, such as microscopy, PCR (where available), POC-CCA (where available), and serum CAA results). All subjects with chronic schistosomiasis according to site-specific diagnostic practice will have a standardized baseline clinical and laboratory evaluation at the time of evaluation that will include blood sampling for hematology, schistosome serology available at each site, and schistosome PCR where available; urine sampling for microscopy, determination of hematuria as an indirect marker of morbidity for schistosomiasis, and Schistosome PCR (where available), and urine strip testing POC-CCA (where available); and stool sampling for microscopy and PCR, where available, and fecal occult blood as indirect markers of schistosomiasis morbidity. Composite reference standards will be used to assess and classify the activity of the infection. Organ-specific ultrasound and other tests will be left to the physician's decision, but results will also be collected. Serum (at least 1 ml remaining from routine diagnostics) will be sent to LUMC, the Netherlands, where CAA will be determined with the UCP-LF CAA test designed for routine use. Participants will be asked to sign an additional consent form, which is optional and not precluding enrollment in the study, to allow the remaining serum to be stored at LUMC for 15 years, to allow secondary research.
Interventions
DEVICEUCP-LF CAA assay
dry LF-CAA, or CAA
Sponsors
Leiden University Medical Center (LUMC)
IRCCS Sacro Cuore Don Calabria di Negrar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. diagnosis of chronic schistosomiasis (\>3 months after last potential exposure) according to site-specific diagnostic practice 2. signed informed consent (and assent for minors).
Exclusion criteria
1. age below 5 years; 2. exposure to praziquantel after the last potential exposure to schistosomes 3. acute infection, i.e. likely infection \<3 months before presentation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Active infection | Baseline | Proportion of enrolled participants fulfilling the composite reference standards for active infection: * Microscopy (Positive/Negative) * PCR (Positive/Negative, if performed) * CAA (Positive/Negative) * Serology (Positive/Negative) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CAA result | Baseline | Number of enrolled participants with positive CAA result at inclusion compared to number of those fulfilling the composite reference standards active infection and of those positive by each separate diagnostic method * Microscopy (P/N) * PCR (P/N) * CAA (P/N) * Serology (P/N) * POC-CCA (P/N) * Signs/symptoms (eosinophilia (Y/N; eos/μL), hematuria (Y/N), fecal occult blood (Y/N), bladder mucosal lesions (Y/N, if ultrasound performed) |
Other
| Measure | Time frame | Description |
|---|---|---|
| CAA cure | At week 6 post-treatment | Number of participants who will be CAA negative at week 6 post-treatment compared to number of participants fulfilling the definitions of cure and to number of negative results by each other separate diagnostic method. * Microscopy - viable eggs (P/N) * CAA (P/N) * Signs/symptoms (eosinophilia (Y/N; eos/μL), hematuria (Y/N), fecal occult blood (Y/N) |
Countries
Belgium, Germany, Italy, Netherlands, Spain
Contacts
Primary ContactElvia Malo
Outcome results
None listed