Whipple Disease Clinical Trial
— WHOOfficial title:
Detection and Characteristic of Whipple Diseases in the Great Britany
| Verified date | February 2018 |
| Source | University Hospital, Brest |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Whipple's disease is a chronic systemic infection caused by ubiquitous bacterium Tropheryma
wipplei on a genetic predisposition which should be considered in patients with recurrent
episodes of seronegative arthritis, erosive or not, or inflammatory low back pain, chronic
diarrhea, persistent fever, unexplained neurological signs, uveitis, endocarditis, and
epithelioid granuloma.
Laboratory tests may show malabsorption, erythrocyte sedimentation rate and C-reactive
protein elevation, anemia, thrombocytosis, eosinophilia and lymphopenia.
None of theses findings is specific and most patients have arthritis or low back pain
mimicking rheumatoid arthritis and spondyloarthritis.
As the disease is rare, chance for positive polymerase chain reaction testing for Tropheryma
whipplei is low in this context.
| Status | Completed |
| Enrollment | 267 |
| Est. completion date | February 9, 2018 |
| Est. primary completion date | February 9, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Adult - patient with at least a screening test for Whipple'disease - participation agreement, Exclusion Criteria: - No test for Whipple'disease |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU d'ANGERS | Angers | |
| France | CHRU de Brest | Brest | |
| France | CH le MAns | Le Mans | |
| France | CHU de Nantes | Nantes | |
| France | CH d'ORLEANS | Orleans | |
| France | CHU de POITIERS | Poitiers | |
| France | CHU de Rennes | Rennes | |
| France | CHU de Tours | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Brest |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients diagnosed as whipple's disease | Diagnosis of Whipple's disease based on at least one suggestive clinical finding at least one test detecting T. Whipplei diagnosis made by a specialist a dramatic and persistent response to antibiotic therapy Hydroxychloroquine 200mgx2 plus Doxycycline 100mgx2 or trimethoprim/sulfamethoxazole 800/160mg x2 |
Day 0 ( Date of diagnostic) | |
| Secondary | Number of test performed in each centre | Number of diagnoses according to tests Patients will be divided into three groups Classic Whipple's disease (CWD), defined as : duodenal biopsy positive by PAS/immunohistochemistry or blood positive by PCR Focal Whipple's disease (FWD) joint fluid positive by PCR but duodenal biopsy negative by PAS/immunohistochemistry Chronic T. whipplei-associated arthritis (CTWA): chronic arthritis and duodenal biopsy, stool, or saliva positive by PCR duodenal biopsy negative by PAS/immunohistochemistry joint fluid negative by PCR |
Day 0 (Date of diagnostic) |