Intraveneous induction theraphy followed by oral theraphy against exclusive oral theraphy: randomized trial for the treatment of Whipple's disease
- Conditions
- ICD 10 K90.8Sonstige intestinale Malabsorption - Whipple diseaseMedDRA version: 9.1Level: LLTClassification code 10047931Term: Whipple's disease
- Registration Number
- EUCTR2008-003951-54-DE
- Lead Sponsor
- Charité University Medicine Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>- Decline of the symptoms specific for Whipple's disease<br>
- Secondary Outcome Measures
Name Time Method