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.
diagnosis of chronic schistosomiasis (>3 months after last potential exposure) according to site-specific diagnostic practice
signed informed consent (and assent for minors).
age below 5 years;
exposure to praziquantel after the last potential exposure to schistosomes
acute infection, i.e. likely infection <3 months before presentation
Single group
UCP-LF CAA assay
Devicedry LF-CAA, or CAA
Active infection
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)
CAA result
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)
CAA cure
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)
Click on the lead sponsor to view all of their trials.
IRCCS Sacro Cuore Don Calabria di Negrar
Lead sponsor
Leiden University Medical Center (LUMC)
Collaborator
