|
ISRCTN
|
ISRCTN88750971
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
PILA trial: Levofloxacin vs piperacillin/sulbactam and sultamicillin in patients with acute cholecystitis
|
|
Scientific title
|
|
|
Acronym
|
PILA
|
|
Serial number at source
|
PIL-629-WEB-0128-I
|
|
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.
|
|
Ethics approval
|
Ethics Committee of the Technical University of Munich. Date of approval: 04/03/2008.
|
|
Study design
|
Double-blind, randomised, single-centre trial
|
|
Countries of recruitment
|
Germany
|
|
Disease/condition/study domain
|
Acute cholecystitis
|
|
Participants - inclusion criteria
|
1. Clinical signs of acute cholecystitis
2. Acute cholecystitis identified by transabdmonial ultrasound
3. Elevated infection parameters
4. Age 18-90 years
|
|
Participants - 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
|
|
Anticipated start date
|
01/04/2008
|
|
Anticipated end date
|
30/04/2010
|
|
Status of trial
|
Ongoing
|
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
142
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Number of days in hospital (in-patient)
|
|
Secondary outcome measure(s)
|
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
|
|
Sources of funding
|
Sanofi Aventis (France)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Andreas
Weber
|
|
Address
|
Klinikum rechts der Isar
II. Medizinische Klinik
Ismaninger Str. 22
|
|
City/town
|
Munich
|
|
Zip/Postcode
|
81675
|
|
Country
|
Germany
|
|
Tel
|
+49 89 4140 6323
|
|
Fax
|
+49 89 4140 6322
|
|
Email
|
Andreas.Weber@lrz.tu-muenchen.de
|
|
Sponsor
|
Technical University of Munich (Germany)
|
|
Address
|
Ismaninger Str. 22
|
|
City/town
|
Munich
|
|
Zip/Postcode
|
81675
|
|
Country
|
Germany
|
|
Email
|
Andreas.Weber@lrz.tu-muenchen.de
|
|
Sponsor website:
|
http://www.dekanat.med.tum.de
|
|
Date applied
|
17/03/2008
|
|
Last edited
|
12/06/2008
|
|
Date ISRCTN assigned
|
12/06/2008
|
