Levofloxacin vs piperacillin/sulbactam and sultamicillin in patients with bacterial cholangitis: A double-blind, randomised study

ISRCTN	ISRCTN90588401
DOI	https://doi.org/10.1186/ISRCTN90588401
Protocol serial number	LAP-387-HUB-0128-l
Sponsor	Technical University Munich (Germany)
Funder	Sanofi Aventis (France)

Submission date: 13/02/2008
Registration date: 30/04/2008
Last edited: 22/11/2011

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andreas Weber
Scientific

Klinikum rechts der Isar
II. Medizinische Klinik
Ismaninger Strasse 22
Munich
81675
Germany

Phone	+49 89 4140 6323
Email	Andreas.Weber@lrz.tu-muenchen.de

Study information

Primary study design	Interventional
Study design	Double-blind, randomised, single-centre controlled trial.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	LAPIS
Study objectives	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(s)	Ethics Committee of the Technical University of Munich. Date of approval: 23/08/2006
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Levofloxacin, piperacillin, sulbactam and sultamicillin.
Primary outcome measure(s)	Number of days in hospital (in-patient)
Key secondary outcome measure(s)	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
Completion date	30/04/2009
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	90 Years
Sex	All
Target sample size at registration	128
Key inclusion criteria	1. Clinical signs of bacterial cholangitis 2. Elevated cholestase parameters 3. Elevated infection parameters 4. Age 18-90 years
Key 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
Date of first enrolment	02/05/2007
Date of final enrolment	30/04/2009

Locations

Countries of recruitment

Germany

Study participating centre

Klinikum rechts der Isar

Munich
81675
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes