Contact information
Type
Scientific
Primary contact
Dr Andreas Weber
ORCID ID
Contact details
Klinikum rechts der Isar
II. Medizinische Klinik
Ismaninger Str. 22
Munich
81675
Germany
+49 89 4140 6323
Andreas.Weber@lrz.tu-muenchen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PIL-629-WEB-0128-I
Study information
Scientific title
Acronym
PILA
Study hypothesis
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
Ethics Committee of the Technical University of Munich. Date of approval: 04/03/2008.
Study design
Double-blind, randomised, single-centre 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
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 names
Levofloxacin, piperacillin, sulbactam and sultamicillin.
Primary outcome measures
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 trial start date
01/04/2008
Overall trial end date
16/05/2012
Reason abandoned
Participant recruitment issue
Eligibility
Participant inclusion criteria
1. Clinical signs of acute cholecystitis
2. Acute cholecystitis identified by transabdmonial ultrasound
3. Elevated infection parameters
4. Age 18-90 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
142
Participant 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
Recruitment start date
01/04/2008
Recruitment end date
16/05/2012
Locations
Countries of recruitment
Germany
Trial participating centre
Klinikum rechts der Isar
Munich
81675
Germany
Sponsor information
Organisation
Technical University of Munich (Germany)
Sponsor details
Ismaninger Str. 22
Munich
81675
Germany
Andreas.Weber@lrz.tu-muenchen.de
Sponsor type
University/education
Website
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