Condition category
Digestive System
Date applied
04/02/2008
Date assigned
16/04/2008
Last edited
16/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eduardo Jaurrieta

ORCID ID

Contact details

Joan Fabregat
Servei de Cirurgia General i Digestiva
Unitat Cirurgia Hepatobilio-Pancreàtica i Trasplantament Hepàtic
Hospitalet de Llobregat
Barcelona
08907
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CGD001/98

Study information

Scientific title

A double-blind, placebo-controlled trial of ciprofloxacin prophylaxis in patients with acute necrotising pancreatitis

Acronym

CIPRONAP

Study hypothesis

Our aim was to assess the effects of intravenous prophylactic ciprofloxacin in the incidence of infected necrosis and mortality in patients with necrotising pancreatitis, compared to a control population.

Ethics approval

Ethics approval received from the Ethics Committee of the L'Hospitalet de Llobregat (Spain) on the 12th December 1998 (ref: 129/98).

Study design

Prospective, randomised, placebo-controlled, double blind study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute pancreatitis

Intervention

All patients with acute pancreatitis suspected to have the severe form of the disease underwent a dynamic contrast-enhanced CT scanning within 48 - 72 hours of admission. When the CT showed a pancreatic necrosis patients signed a written consent, and were randomly assigned to receive one of the below:
1. Prophylactic antibiotic treatment: 300 mg ciprofloxacin every 12 hours for 10 days (n = 22)
2. Placebo (n = 19)

All patients were treated medically on admission (aggressive fluid resuscitation along with electrolyte imbalance, complete avoidance of oral intake, pain control and total parenteral nutrition). Patients with organ failure were followed in the intensive care unit (ICU). When infected necrosis was clinically suspected, a CT-guided fine-needle aspiration (FNA) followed by a Gram stain and a bacteriologic culture was carried out. If infection could be diagnosed through these procedures, we indicated surgical treatment. Further indications for surgery were: diagnostic doubt, organ failure despite intensive medical treatment and symptomatic sterile necrosis (defined as persistent abdominal pain or inability to eat after 4 to 6 weeks of medical management).

Intervention type

Drug

Phase

Not Specified

Drug names

Ciprofloxacin

Primary outcome measures

To determine whether prophylaxis with intravenous ciprofloxacin could reduce the incidence of infected pancreatic necrosis.

Secondary outcome measures

Effects on:
1. Mortality rate
2. Extra-pancreatic infections
3. Surgical treatment, its timing and the re-operation rate
4. Development of organ failure 2
5. In-hospital as well as intensive care unit (ICU) length of stay

Overall trial start date

01/05/1999

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

All adult patients of either sex:
1. Without previous antibiotic treatment
2. With detectable pancreatic necrosis in a contrast-enhanced computed tomography (CT) scan 25 performed within 48 - 72 hours of admission

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Antibiotic allergy
2. Clinical evidence of sepsis on admission

Recruitment start date

01/05/1999

Recruitment end date

31/12/2003

Locations

Countries of recruitment

Spain

Trial participating centre

Joan Fabregat
Barcelona
08907
Spain

Sponsor information

Organisation

Hospital Universitari De Bellvitge (Spain)

Sponsor details

Feixa Llarga S.N.
Hopsitalet de Llobregat
Barcelona
08907
Spain

Sponsor type

University/education

Website

http://www.csub.scs.es

Funders

Funder type

Hospital/treatment centre

Funder name

Bellvitge Hospital (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

No grant nor payment from the pharmaceutical industry.

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