PILA trial: Levofloxacin vs piperacillin/sulbactam and sultamicillin in patients with acute cholecystitis
| ISRCTN | ISRCTN88750971 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88750971 |
| Secondary identifying numbers | PIL-629-WEB-0128-I |
- Submission date
- 17/03/2008
- Registration date
- 12/06/2008
- Last edited
- 22/05/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
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 Str. 22
Munich
81675
Germany
| Phone | +49 89 4140 6323 |
|---|---|
| Andreas.Weber@lrz.tu-muenchen.de |
Study information
| Study design | Double-blind, randomised, single-centre 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 | PILA |
| Study objectives | In patients with acute cholecystitis 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 cholecystitis and by a sufficient concentration in the bile and gallbladder tissue. To evaluate the clinical efficacy of levofloxacin we perform this prospective randomised trial. As of 22/05/2012, the anticipated end date of trial has been updated from 30/04/2010 to 16/05/2012. |
| Ethics approval(s) | Ethics Committee of the Technical University of Munich. Date of approval: 04/03/2008. |
| Health condition(s) or problem(s) studied | Acute cholecystitis |
| Intervention | Control group: Piperacillin 4 g or 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 + 2 x daily placebo capsule (0.9% NaCl) for 2 days, then levofloxacin 0.5 g p.o. 1 x daily + 1 x daily placebo capsule for 2 - 8 days. |
| 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 | The following will be monitored during the treatment: 1. Change of antibiotic therapy 2. Duration of antibiotic therapy 3. Fever 4. Laboratory parameters 5. Complications of antibiotic therapy |
| Overall study start date | 01/04/2008 |
| Completion date | 16/05/2012 |
| 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 | 142 |
| Key inclusion criteria | 1. Clinical signs of acute cholecystitis 2. Acute cholecystitis identified by transabdmonial ultrasound 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 incompatibility 5. Fluorochinolon incompatibility 6. Renal failure 7. AIDS 8. Liver cirrhosis 9. Seizure disorder |
| Date of first enrolment | 01/04/2008 |
| Date of final enrolment | 16/05/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinikum rechts der Isar
Munich
81675
Germany
81675
Germany
Sponsor information
Technical University of Munich (Germany)
University/education
University/education
Ismaninger Str. 22
Munich
81675
Germany
| Andreas.Weber@lrz.tu-muenchen.de | |
| Website | http://www.dekanat.med.tum.de |
"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 |
