Detection and Characteristic of Whipple Diseases in the Great Britany

Completed

• Conditions: Whipple Disease

• Registration Number: NCT03350685
• Lead Sponsor: University Hospital, Brest

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-15
• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-22
• Status Verified: 2018-02
• Primary Completion: 2018-02-09
• Study Completion: 2018-02-09
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

• Adult
• patient with at least a screening test for Whipple'disease
• participation agreement,

Exclusion Criteria

• No test for Whipple'disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients diagnosed as whipple's disease	Day 0 ( Date of diagnostic)	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

Secondary Outcome Measures

Name	Time	Method
Number of test performed in each centre	Day 0 (Date of diagnostic)	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

Trial Locations

Locations (8)

CHU d'ANGERS; 🇫🇷 Angers, France

CHRU de Brest; 🇫🇷 Brest, France

CH le MAns; 🇫🇷 Le Mans, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU de Tours; 🇫🇷 Tours, France

CHU de Rennes; 🇫🇷 Rennes, France

CH d'ORLEANS; 🇫🇷 Orleans, France

CHU de POITIERS; 🇫🇷 Poitiers, France