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 |
| Secondary identifying numbers | LAP-387-HUB-0128-l |
- 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
Scientific
Klinikum rechts der Isar
II. Medizinische Klinik
Ismaninger Strasse 22
Munich
81675
Germany
| Phone | +49 89 4140 6323 |
|---|---|
| Andreas.Weber@lrz.tu-muenchen.de |
Study information
| Study design | Double-blind, randomised, single-centre controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Levofloxacin, piperacillin, sulbactam and sultamicillin. |
| Primary outcome measure | 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 study start date | 02/05/2007 |
| 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 | Both |
| Target number of participants | 128 (37 included before trial discontinued) |
| 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
81675
Germany
Sponsor information
Technical University Munich (Germany)
University/education
University/education
Ismaninger Strasse 22
Munich
81675
Germany
| Phone | +49 89 4140 6323 |
|---|---|
| Andreas.Weber@lrz.tu-muenchen.de | |
| Website | http://portal.mytum.de/tum/index_html |
"ROR" |
https://ror.org/02kkvpp62 |
Funders
Funder type
Industry
Sanofi Aventis (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
