Contact information
Type
Scientific
Primary contact
Dr Andreas Weber
ORCID ID
Contact details
Klinikum rechts der Isar
II. Medizinische Klinik
Ismaninger Strasse 22
Munich
81675
Germany
+49 89 4140 6323
Andreas.Weber@lrz.tu-muenchen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LAP-387-HUB-0128-l
Study information
Scientific title
Acronym
LAPIS
Study hypothesis
In patients with acute cholangitis the use of broad spectrum penicillin is generally accepted. However, due to increasing resistance and allergic reactions, other antibacterial agents may become necessary. Levofloxacin is characterized by an enhanced activity against pathogens of acute cholangitis and by a sufficient concentration in the bile. To evaluate the clinical efficacy of levofloxacin we perform this prospective randomized trial.
Ethics approval
Ethics Committee of the Technical University of Munich. Date of approval: 23/08/2006
Study design
Double-blind, randomised, single-centre controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Bacterial cholangitis
Intervention
Control group: Piperacillin 4 g/sulbactam 1 g intravenously (i.v.) 3 x daily for 2 days, then sultamicillin 0.75 g orally (p.o.) 2 x daily for 2-8 days.
Experimental group: Levofloxacin 0.5 g i.v. 1 x daily for 2 days, additionally 2 x daily placebo (0.9% NaCl), then levofloxacin 0.5 g p.o. 1 x daily for 2-8 days, additionally 1 x daily placebo capsule.
Trial stopped as of 28/09/2011 due to poor recruitment.
Intervention type
Drug
Phase
Not Specified
Drug names
Levofloxacin, piperacillin, sulbactam and sultamicillin.
Primary outcome measures
Number of days in hospital (in-patient)
Secondary outcome measures
1. Change of antibiotic therapy, recorded during the treatment
2. Duration of antibiotic therapy during the interventions
3. Fever, monitored during the treatment
4. Laboratory parameters
5. Complications of antibiotic therapy during the treatment
Overall trial start date
02/05/2007
Overall trial end date
30/04/2009
Reason abandoned
Participant recruitment issue
Eligibility
Participant inclusion criteria
1. Clinical signs of bacterial cholangitis
2. Elevated cholestase parameters
3. Elevated infection parameters
4. Age 18-90 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
128 (37 included before trial discontinued)
Participant exclusion criteria
1. Potential other cause of infection
2. Pregnancy
3. Psychiatric disease
4. Penicillin incompatibillity
5. Fluorochinolon incompatibillity
6. Leucopenia
7. Immunosuppressive medication
8. AIDS
9. Liver cirrhosis
10. Microbiological resistance against study medication
11. Biliary pancreatitis
12. Antibiotic pre-treatment within 48 hour before study inclusion
Recruitment start date
02/05/2007
Recruitment end date
30/04/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Klinikum rechts der Isar
Munich
81675
Germany
Sponsor information
Organisation
Technical University Munich (Germany)
Sponsor details
Ismaninger Strasse 22
Munich
81675
Germany
+49 89 4140 6323
Andreas.Weber@lrz.tu-muenchen.de
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Sanofi Aventis (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary