Multi-center Clinical Study of Early Antibios of Severe Acute Pancreatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Ruijin Hospital
Sponsor:
Collaborator:
RenJi Hospital
Information provided by (Responsible Party):
Erzhen Chen, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT01992198
First received: October 31, 2013
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Pancreatitis,Acute Necrotizing
Drug: cefoperazone + metronidazole
Procedure: oral care by chlorhexidine gluconate
Procedure: enteral nutrition
Drug: Somatostatin
Drug: Meropenem
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Escalade or Deseacalade Antibiotic Use in Severe Acute Pancreatitis

Resource links provided by NLM:


Further study details as provided by Ruijin Hospital:

Primary Outcome Measures:
  • pancreatic or peripancreatic infection [ Time Frame: 28-day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • cost of management of SAP [ Time Frame: 90-day ] [ Designated as safety issue: No ]
  • Microbiology resistance [ Time Frame: 90-day ] [ Designated as safety issue: Yes ]
    sputum, urine and blood culture will be done once or twice per week if needed. bill or other culutre will be done when the patient is undergoing operation.


Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cefoperazone + metronidazole
cefoperaozone 2g q8h + MDZ 0.5g q8h Oral care Somatostatin 3-6mg per 24h enteral nutrition
Procedure: oral care by chlorhexidine gluconate
oral care by 0.2% chlorhexidine gluconate twice daily
Other Name: chlorhexidine gluconate
Procedure: enteral nutrition
Other Name: Enteral Nutritional Suspension(SP) by NUTRICIA
Drug: Somatostatin
Other Name: somatostatin by merk
Drug: Meropenem

All patients in cefo-group do not meet 1 of 3 laboratory parameter or image parameter or 2 of 3 clinical parameters.

1.Clinical parameters (2 of 3):

1)temperature<37.8℃ or 2)HR <100bpm or 3)SpO2 >95% 2.Laboratory parameters (3 of 3):

1)CRP or 2)PCT reduction 70% compared to zenith for 2 consecutive samples 3)WBC <12×10E9/L for 2 consecutive samples 3.Image parameter (1 of 1): liquid collection developed <30% compared to that of 72h

Active Comparator: meropenem
Meropenem 0.5g q6h or adapted with renal function. Oral care Somatostatin 3-6mg per 24h enteral nutrition
Drug: cefoperazone + metronidazole

1.Clinical parameters (2 of 3):

1)temperature<37.8℃ or 2)HR <100bpm or 3)SpO2 >95% 2.Laboratory parameters (3 of 3):

1)CRP or 2)PCT reduction 70% compared to zenith for 2 consecutive samples 3)WBC <12×10E9/L for 2 consecutive samples 3.Image parameter (1 of 1): liquid collection developed <30% compared to that of 72h

Other Names:
  • Cefobid
  • Metronidazole
Procedure: oral care by chlorhexidine gluconate
oral care by 0.2% chlorhexidine gluconate twice daily
Other Name: chlorhexidine gluconate
Procedure: enteral nutrition
Other Name: Enteral Nutritional Suspension(SP) by NUTRICIA
Drug: Somatostatin
Other Name: somatostatin by merk

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01992198

Contacts
Contact: Erzhen Chen, M.D 86-13901753478
Contact: Enqiang Mao, M.D 86-13501747906

Locations
China, Shanghai
Depatrment of EICU,Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Erzhen Chen, M.D    86-13901753478      
Contact: Enqiang , Mao    86-13501747906      
Sub-Investigator: Zhitao Yang, M.D         
Sponsors and Collaborators
Erzhen Chen
RenJi Hospital
Investigators
Study Chair: Er-Zhen Chen, M.D. & Ph.D. Ruijin Hospital
Study Director: En-Qiang Mao, M.D. & Ph.D. Ruijin Hospital
Principal Investigator: Zhi-Tao Yang, M.D. & Ph.D. Ruijin Hospital
  More Information

No publications provided

Responsible Party: Erzhen Chen, Professer, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT01992198     History of Changes
Other Study ID Numbers: SAP BUNDLE-ANTIBIOTICS, 12411950500
Study First Received: October 31, 2013
Last Updated: November 18, 2013
Health Authority: China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Ruijin Hospital:
antibiothearpy strategy
cefoperazone
metronidazole
meropenem

Additional relevant MeSH terms:
Pancreatitis, Acute Necrotizing
Pancreatitis
Digestive System Diseases
Pancreatic Diseases
Cefoperazone
Chlorhexidine
Chlorhexidine gluconate
Meropenem
Metronidazole
Somatostatin
Sulperazone
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Anti-Infective Agents, Urinary
Antiparasitic Agents
Antiprotozoal Agents
Dermatologic Agents
Disinfectants
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014