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Intravenous Immunoglobulin in Combination Therapy With Antibacterial Agents for SSI of the Lower Digestive Tract

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00511212
Recruitment Status : Withdrawn (No eligible patient.)
First Posted : August 3, 2007
Last Update Posted : July 21, 2011
Sponsor:
Information provided by:
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Study Description
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Brief Summary:
The purpose of this study is to assess the clinical usefulness of IVIG in combination therapy with antibacterial agents for severe peritonitis after lower digestive tract surgery.

Condition or disease Intervention/treatment Phase
Peritonitis Postoperative Complications Drug: intravenous immunoglobulin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Intravenous Immunoglobulin (IVIG) in Combination Therapy With Antibacterial Agents for Surgical Site Infection of the Lower Digestive Tract
Study Start Date : August 2007
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. clinical efficacy [ Time Frame: at day 7 ]

Secondary Outcome Measures :
  1. clinical efficacy, recurrence rate, mortality, time between drug administration and defervescence, defervescence rate,time between drug administration and disappearance of clinical symptoms, improvement rate on clinical symptoms [ Time Frame: at day 3 and at the end of test drug administration, ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients who have obvious symptoms and observation of post-surgical peritonitis, and meet the criteria described bellow.

  1. Patients with >=38 degrees C, >=15,000/mm3 or <=3,000/mm3 of WBC and >=10mg/dL of CRP
  2. Patients who have no abscess on the abdominal image
  3. Patients who were administered antibacterial agents for 1 day or more, and show no sign of improvement
  4. Patients who are 20 years old or older
  5. Patients who have signed the agreement for participation in this study

Exclusion Criteria:

  1. Patients who have a history of hypersensitivity to any of the ingredients of Immunoglobulin products
  2. Patients who have a history of shock due to any of the ingredients of Immunoglobulin products
  3. Patients who were administered immunoglobulin within 1 month before entry
  4. Patients who were administered antibacterial agents for 1 day or more, and show signs of improvement
  5. Patients with IgA deficiency
  6. Patients with hereditary fructose intolerance
  7. Patients with history of allergy or adverse effect for antibacterial agents
  8. Patients who have underlying or concomitant disease that may seriously affect the assessment of this study
  9. Patients who are or could be pregnant
  10. Patients who have noninfectious fever, fungal infection or viral illness
  11. Other patients who are judged to be inadequate to participate in this study by their physician
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511212


Locations
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Japan
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Sponsors and Collaborators
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Investigators
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Study Chair: Morito Monden, MD, PhD Multicenter Clinical Study Group of Osaka
More Information
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ClinicalTrials.gov Identifier: NCT00511212    
Other Study ID Numbers: MCSGO-0701
First Posted: August 3, 2007    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: August 2007
Keywords provided by Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group:
severe peritonitis
SSI
lower digestive tract surgery
Severe peritonitis after lower digestive tract surgery
Additional relevant MeSH terms:
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Peritonitis
Postoperative Complications
Pathologic Processes
Intraabdominal Infections
Infections
Peritoneal Diseases
Digestive System Diseases
 Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs