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

NCT01992198 | Unknown Phase 4

• 2 other identifiers: SAP BUNDLE-ANTIBIOTICS12411950500
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatitis,Acute Necrotizing

Keywords

antibiothearpy strategy; cefoperazone; metronidazole; meropenem

Outcome Measures

Primary Outcomes (1)

• pancreatic or peripancreatic infection

  28-day

Secondary Outcomes (2)

• cost of management of SAP

  90-day

• Microbiology resistance

  90-day

Study Arms (2)

cefoperazone + metronidazole

EXPERIMENTAL

cefoperaozone 2g q8h + MDZ 0.5g q8h Oral care Somatostatin 3-6mg per 24h enteral nutrition

Procedure: oral care by chlorhexidine gluconate; Procedure: enteral nutrition; Drug: Somatostatin; Drug: Meropenem

meropenem

ACTIVE COMPARATOR

Meropenem 0.5g q6h or adapted with renal function. Oral care Somatostatin 3-6mg per 24h enteral nutrition

Drug: cefoperazone + metronidazole; Procedure: oral care by chlorhexidine gluconate; Procedure: enteral nutrition; Drug: Somatostatin

Interventions

cefoperazone + metronidazole DRUG

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

Also known as: Cefobid, Metronidazole

meropenem

oral care by chlorhexidine gluconate PROCEDURE

oral care by 0.2% chlorhexidine gluconate twice daily

Also known as: chlorhexidine gluconate

cefoperazone + metronidazole; meropenem

enteral nutrition PROCEDURE

Also known as: Enteral Nutritional Suspension(SP) by NUTRICIA

cefoperazone + metronidazole; meropenem

Somatostatin DRUG

Also known as: somatostatin by merk

cefoperazone + metronidazole; meropenem

Meropenem DRUG

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

cefoperazone + metronidazole

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• severe Acute Pancreatitis according to Atlanta criteria revisited in 2012

You may not qualify if:

• 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

Sponsors & Collaborators

• Erzhen Chen: lead
• RenJi Hospital: collaborator

Study Sites (1)

Depatrment of EICU,Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Interventions

Cefoperazone; Metronidazole; chlorhexidine gluconate; Enteral Nutrition; Somatostatin; Meropenem

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cefamandole; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy; Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Thienamycins; Carbapenems

Study Officials

• Er-Zhen Chen, M.D. & Ph.D.

  Ruijin Hospital

  STUDY CHAIR

• En-Qiang Mao, M.D. & Ph.D.

  Ruijin Hospital

  STUDY DIRECTOR

• Zhi-Tao Yang, M.D. & Ph.D.

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erzhen Chen, M.D

CONTACT

86-13901753478

Enqiang Mao, M.D

CONTACT

86-13501747906

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professer

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 25, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

CN (1)