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ISRCTN
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ISRCTN90588401
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ClinicalTrials.gov identifier
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Public title
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Levofloxacin vs piperacillin/sulbactam and sultamicillin in patients with bacterial cholangitis: A double-blind, randomised study
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Scientific title
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Acronym
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LAPIS
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Serial number at source
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LAP-387-HUB-0128-l
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Study hypothesis
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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.
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Ethics approval
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Ethics Committee of the Technical University of Munich. Date of approval: 23/08/2006
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Study design
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Double-blind, randomised, single-centre controlled trial.
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Bacterial cholangitis
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Participants - inclusion criteria
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1. Clinical signs of bacterial cholangitis
2. Elevated cholestase parameters
3. Elevated infection parameters
4. Age 18-90 years
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Participants - exclusion criteria
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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
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Anticipated start date
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02/05/2007
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Anticipated end date
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30/04/2009
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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128
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Interventions
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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.
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Primary outcome measure(s)
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Number of days in hospital (in-patient)
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Secondary outcome measure(s)
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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
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Sources of funding
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Sanofi Aventis (France)
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Trial website
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Publications
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Contact name
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Dr
Andreas
Weber
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Address
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Klinikum rechts der Isar
II. Medizinische Klinik
Ismaninger Strasse 22
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City/town
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Munich
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Zip/Postcode
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81675
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Country
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Germany
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Tel
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+49 89 4140 6323
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Fax
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+49 89 4140 6322
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Email
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Andreas.Weber@lrz.tu-muenchen.de
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Sponsor
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Technical University Munich (Germany)
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Address
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Ismaninger Strasse 22
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City/town
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Munich
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Zip/Postcode
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81675
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Country
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Germany
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Tel
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+49 89 4140 6323
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Fax
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+49 89 4140 6322
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Email
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Andreas.Weber@lrz.tu-muenchen.de
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Sponsor website:
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http://portal.mytum.de/tum/index_html
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Date applied
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13/02/2008
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Last edited
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30/04/2008
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Date ISRCTN assigned
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30/04/2008
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