evofloxacin vs Piperacillin/Sulbactam and Sultamicillin in patients with bacterial cholangitis. A double blind, randomiized study. - LAPIS
- Conditions
- bacterial cholangitis
- Registration Number
- EUCTR2006-004122-90-DE
- Lead Sponsor
- Medizinische Fakultät der Technischen Universität München, Vertreten durch den Dekan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- clinical signs of bacterial cholangitis
- elevated cholestase parameters
- elevated infection parameters
- age 18 - 90 years
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
- potential other cause of infection
- pregnancy
- psychiatric disease
- Penicillin incompatibillity
- Fluorochinolon incompatibillity
- leucopenia
- immunosuppressive medication
- AIDS
- liver cirrhosis
- microbiological restistance against study medication
- biliary pancreatitis
- antibiotic pretreatment within 48 hour before study inclusion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: number of days in hospiatl (in-patient);Secondary Objective: - change of antibiotic therapy<br>- duration of antibiotic therapy<br>- fever<br>- laboratory parameters<br>- complications of antibiotic therapy;Primary end point(s): number of days in hospital (in-patient)
- Secondary Outcome Measures
Name Time Method