Study on the initial treatment of Whipple's disease

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN45658456
• Date of registration: 21/07/2004
• Prospective Registration: No
• Primary sponsor: German Red Cross Hospital Neuwied (DRK Krankenhaus Neuwied)
• Public title: Study on the initial treatment of Whipple's disease
• Date of first enrolment: 01/01/1999
• Target sample size: 62
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN45658456
• Study type: Interventional
• Study design: Open label, parallel group, randomised controlled trial. (Not Specified)

Countries of recruitment

Austria, France, Germany, Switzerland

Contacts

• Name: Gerhard E. Feurle

Key inclusion & exclusion criteria

Inclusion criteria: Patients with Whipple-typical macrophages in the duodenal mucosa or elsewhere confirmed by the reference pathologist
Exclusion criteria: 1. Current antimicrobial therapy for more than 1 month
2. Previous and unsuccessful antimicrobial therapy for Whipple's Disease
3. Recurrence of Whipple's Disease
4. Human Immunodeficiency Virus (HIV) infection, pregnancy, manifest tumor disease (except lymphoma)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Whipple's Disease
Digestive System
Whipple's disease

Intervention(s)

Amended on 17/08/2007:

Intravenous ceftriaxon versus intravenous meropenem/imipenem, followed by 12 months of oral co-trimoxazole. Enrolment for these two arms was completed in December 2003.

A non-randomised third arm to SIMW (with additional 20 patients) was started in July 2004. The participants in the third arm receive intravenous ceftriaxone (as in the first arm of SIMW), followed by oral co-trimoxazole for three months (instead of 12 months). Otherwise the protocols are identical to the other two arms. The third arm, therefore, examines whether short-term oral treatment with co-trimoxazole is noninferior to 12 months oral treatment. This third arm without an own control group will be compared with the two arms of SIMW. The third arm was introduced in order to facilitate participant recruitment as Whipple's disease is very rare.

Dosages:
Ceftriaxone 2 g daily intravenously for 14 days (in the first arm of SIMW and in the third arm)
Meropenem 3 x 1 g daily intravenously for 14 days (in the second arm of SIMW)(In this intent to treat trial imipenem can be used instead of meropenem).

Co-trimoxazole contains 800 mg sulphamethoxazole plus 160 mg trimethoprim, and is administered twice daily perorally in all three arms (In both arms of SIMW for a year, in the third arm for three months).

Interventions provided at time of registration:

Randomized antibiotic treatment: ceftriaxon versus meropenem / imipenem.

In both arms this initial treatment is followed by 12 months of oral co-trimoxazole. Enrolment complete in December 2003. A non-randomised third arm to SIMW was started in July 2004. In this arm we will admit a maximum of 20 new patients until December 2006. This trial SIMW is organised under the premise that WD is a rare disease.

Primary Outcome(s)

Remission maintained for three years

Secondary Outcome(s)

Prospective collection of clinical, immunological, and pathological data concerning diagnosis and course of Whipple's disease.

Secondary ID(s)

N/A

Source(s) of Monetary Support

German Red Cross Hospital Neuwied (DRK Krankenhaus Neuwied), The European Commission (ref: QLG1-CT-2002-01049)