ICD 10 K90.8 Sonstige intestinale Malabsorption - Whipple disease MedDRA version: 9.1 Level: LLT Classification code 10047931 Term: Whipple's disease
Conditions
Interventions
Trade Name: Ceftriaxon
Pharmaceutical Form: Powder for solution for infusion
Trade Name: Trimethoprim, Sulfamethoxazol
Pharmaceutical Form: Tablet
Trade Name: Doxycyclin
Pharmaceutical Form: Tablet
Sponsors
Charité University Medicine Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Macrophages typical for Whipple's disease ascertained in the small intestine biopsy or extraintestinal shown by the Periodic –acid –Schiff (PAS) staining or positive PCR with sequencing for Tropheryma whipplei from liquor or alternative sterile tissue (authoritative lab). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - More than one month of constant antibiotic therapy. - Preceded and fruitless antibiotic therapy because of Whipple's disease . - Relapse of Whipple's disease after former antibiotic therapy. - Apparent severe tumour illness. - HIV-Infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The clinical remission without relapse in the observation period.;Secondary Objective: The histological remission or the elimination of the bacterium from the liquor measured by means of PCR.;Primary end point(s): - Remission and no relapse of the disease during observation period of the study - Decline of the symptoms specific for Whipple's disease | — |
Countries
Germany
Outcome results
None listed