To determine the proportion of travelers and migrants diagnosed with chronic schistosomiasis as per each centre*s routine assessment, who have active infection at presentation (as assessed and classified by composite reference standards integrating…
ID
Source
Brief title
Condition
- Helminthic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective
To determine the proportion of travelers and migrants diagnosed with chronic
schistosomiasis according to site-specific diagnostic practice, who have active
infection at presentation (as assessed and classified by composite reference
standards integrating clinical, laboratory and diagnostic features, such as
microscopy, PCR (where available), POC-CCA (where available), and serum CAA
results).
Endpoint: proportion of enrolled participants fulfilling the composite
reference standards for active infection
Secondary outcome
To explore the accuracy and added value of serum CAA determination as test of
cure 6 weeks after the WHO standard treatment regimen (40 mg/kg single dose
praziquantel), compared to conventional (microscopy) and novel methods (PCR,
POC-CCA) in sites where the latter would be available.
Endpoint: number of participants with initial active infection who will be CAA
negative at week 6 post-treatment compared to number of participants
fulfilling the composite definition of clinical and parasitological cure, and
to number of negative results by each other separate diagnostic method.
Background summary
Conventional methods to diagnose chronic schistosomiasis in the nonendemic
setting usually cannot differentiate between past and active infection, likely
leading to frequent unnecessary treatment. Novel methods, such as the detection
of CAA circulating antigen, have been developed for clinical use in non-endemic
settings. We hypothesize that:
1. The determination of CAA in serum can help identify the subset of travelers
and migrants diagnosed with chronic schistosomiasis who have an ACTIVE infection
2. The determination of CAA in serum can help assess cure within a short
timeframe after treatment in this population
Study objective
To determine the proportion of travelers and migrants diagnosed with chronic
schistosomiasis as per each centre*s routine assessment, who have active
infection at presentation (as assessed and classified by composite reference
standards integrating clinical and laboratory features, including microscopy,
PCR (where available), POC-CCA (where available), and serum CAA results).
Study design
Clinical multicentric prospective cohort study with IVD (not for CE marking),
of travelers and migrants diagnosed with chronic schistosomiasis,
according to site-specific diagnostic practice (that may include microscopy,
locally used serology, in house PCR or POC-CCA)
Study burden and risks
All eligible participants identified as having chronic schistosomiasis
according to site-specific diagnostic practice will have a standardized
baseline clinical and laboratory assessment at enrollment that will include
blood sampling for hematology, Schistosoma serology available at each site, and
PCR for Schistosoma where available; urine sampling for microscopy,
determination of hematuria as indirect markers of schistosomiasis morbidity,
and Schistosoma PCR (where available) and POC-CCA urine strip assay (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 infection
activity. Organ-specific ultrasound and other examinations will be left to the
physician*s decision, but results will also be captured. Serum (at least 1 mL
leftover from routine diagnostics) will be sent to LUMC, Netherlands, where CAA
will be determined with the UCP-LF CAA assay (dry format) designed for routine
use. Participants will be asked to sign an additional consent form, optional
and not precluding the enrollment in the study, to permit the storage of the
leftover serum at LUMC for 15 years, to allow secondary research. All patients
diagnosed with chronic schistosomiasis according to site-specific diagnostic
practice will be treated with the standard WHO regimen (40 mg/kg single-dose
praziquantel) at inclusion, without waiting for the CAA result. All
participants will be seen again after 6 weeks (+/- 1 week) for clinical and
laboratory reevaluation, following the current standard of care, and CAA will
be determined again on leftover serum.
Participation of the patient to the study will terminate at this point.
Administration of additional courses of praziquantel and further follow-up
will be left at the physician*s discretion after the 6 weeks follow-up visit,
based on usual local practice, clinical assessment, and serial results of used
diagnostics.
For this study a single additional blood tube (5 ml) will be withdrawn at the
second hospital visit.
Viale Luigi Rizzardi 4
Negrar di Valpolicella, Verona 37024
IT
Viale Luigi Rizzardi 4
Negrar di Valpolicella, Verona 37024
IT
Listed location countries
Age
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 16 years;
2. exposure to praziquantel after the last potential exposure to schistosomes
3. acute infection, i.e. likely infection <3 months before presentation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87549.078.24 |