Randomised study with ciprofloxacine in acute pancreatitis

ISRCTN	ISRCTN75232398
DOI	https://doi.org/10.1186/ISRCTN75232398
Secondary identifying numbers	CGD001/98

Submission date: 04/02/2008
Registration date: 16/04/2008
Last edited: 16/04/2008

Recruitment status: No longer recruiting
Overall study status: Completed
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

Prof Eduardo Jaurrieta
Scientific

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

Study information

Study design	Prospective, randomised, placebo-controlled, double blind study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A double-blind, placebo-controlled trial of ciprofloxacin prophylaxis in patients with acute necrotising pancreatitis
Study acronym	CIPRONAP
Study objectives	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(s)	Ethics approval received from the Ethics Committee of the L'Hospitalet de Llobregat (Spain) on the 12th December 1998 (ref: 129/98).
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Ciprofloxacin
Primary outcome measure	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 study start date	01/05/1999
Completion date	31/12/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	80
Key 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
Key exclusion criteria	1. Antibiotic allergy 2. Clinical evidence of sepsis on admission
Date of first enrolment	01/05/1999
Date of final enrolment	31/12/2003

Locations

Countries of recruitment

Spain

Study participating centre

Joan Fabregat

Barcelona
08907
Spain

Sponsor information

Hospital Universitari De Bellvitge (Spain)
University/education

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

Website	http://www.csub.scs.es
"ROR"	https://ror.org/00epner96

Funders

Funder type

Hospital/treatment centre

Bellvitge Hospital (Spain)

No information available

No grant nor payment from the pharmaceutical industry.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan