Clinical trial NCT01992198: Multi-center Clinical Study of Early Antibios of Severe Acute Pancreatitis
Official title: Escalade or Deseacalade Antibiotic Use in Severe Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pancreatitis,Acute Necrotizing
Keywords: antibiothearpy strategy
cefoperazone
metronidazole
meropenem
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
First posted: 2013-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Strategy of antibiotic therapy in SAP,De-escalate (cefoperazone+metronidazole) or Escalate (meropenem) therapy,which one is better.

Detailed description: SAP is a serious and life-threatening disease and requires intensive and aggressive management of multiple organ failure and severe infectious complications that can develop in these patients. The most common cause of death in patients suffering from severe acute pancreatitis (SAP) is the infection of pancreatic necrosis by enteric bacteria with mortality rates of 30% (range 14- 62%),spurring the discussion of whether or not prophylactic antibiotic administration could be a beneficial approach. Pancreatic infections are more often monomicrobial, especially E. coli in the two first weeks (100% and 62.5%) of onset, with a shift from gram-negative to gram-positive as the pancreatitis progressed.

In order to evaluate the benefit of prophylactic antibiotic application, a number of randomized controlled clinical trials have been published over the past 15 years. Since the results were conflicting and most studies were of low methodological quality and/or statistically underpowered, meta-analyses have been performed to assess this important issue. However, their results ranged from absolutely no effect of antibiotic prophylaxis to positive effects regarding mortality, the incidence of infected pancreatic necrosis and the incidence of extra pancreatic infections.

In order to provide reliable evidence of the effect of antibiotherapy strategy in SAP, we performed a prospective randomized multicenter clinical trial.

Eligibility criteria: Inclusion Criteria:

* severe Acute Pancreatitis according to Atlanta criteria revisited in 2012

Exclusion Criteria:

* concurrent sepsis or (peri)pancreatic infection caused by a second disease
* patients with chronic organ failure (chronic renal failure needs kidney replacement, chronic heart failure, decompensate hepatic cirrhosis, chronic obstructive pulmonary disease)
* recurrent or endoscopic retrograde cholangiopancreatography (ERCP), or traumatic or operative pancreatitis
* pregnancy, malignancy or immunodeficiency
* a history of allergy to meropenem, cefoperazone and metronidazole
* a history of antibiotic administration within 48 h prior to enrollment
* possible death within 48 h after enrollment

Primary outcomes:
measure: pancreatic or peripancreatic infection
timeFrame: 28-day
Secondary outcomes:
measure: cost of management of SAP
timeFrame: 90-day
measure: Microbiology resistance
timeFrame: 90-day
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Depatrment of EICU,Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Er-Zhen Chen, M.D. & Ph.D.
role: STUDY_CHAIR
affiliation: Ruijin Hospital
name: En-Qiang Mao, M.D. & Ph.D.
role: STUDY_DIRECTOR
affiliation: Ruijin Hospital
name: Zhi-Tao Yang, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: