Condition category
Digestive System
Date applied
17/03/2008
Date assigned
12/06/2008
Last edited
22/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dekanat.med.tum.de

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

Publication citations

Additional files

Editorial Notes