PILA trial: Levofloxacin vs piperacillin/sulbactam and sultamicillin in patients with acute cholecystitis
| ISRCTN | ISRCTN88750971 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88750971 |
| Protocol serial number | PIL-629-WEB-0128-I |
| Sponsor | Technical University of Munich (Germany) |
| Funder | Sanofi Aventis (France) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind, randomised, single-centre trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| 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) |
The following will be monitored during the treatment: |
| 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 | All |
| Target sample size at registration | 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
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 |
