Condition category
Infections and Infestations
Date applied
13/02/2008
Date assigned
30/04/2008
Last edited
22/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://portal.mytum.de/tum/index_html

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

Publication citations

Additional files

Editorial Notes