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

Primary Purpose

Peritonitis, Postoperative Complications

Status
Withdrawn
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
intravenous immunoglobulin
Sponsored by
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritonitis focused on measuring severe peritonitis, SSI, lower digestive tract surgery, Severe peritonitis after lower digestive tract surgery

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Osaka University Hospital

Outcomes

Primary Outcome Measures

clinical efficacy

Secondary Outcome Measures

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

Full Information

First Posted
August 1, 2007
Last Updated
July 20, 2011
Sponsor
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
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1. Study Identification

Unique Protocol Identification Number
NCT00511212
Brief Title
Intravenous Immunoglobulin in Combination Therapy With Antibacterial Agents for SSI of the Lower Digestive Tract
Official Title
Clinical Study of Intravenous Immunoglobulin (IVIG) in Combination Therapy With Antibacterial Agents for Surgical Site Infection of the Lower Digestive Tract
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Withdrawn
Why Stopped
No eligible patient.
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonitis, Postoperative Complications
Keywords
severe peritonitis, SSI, lower digestive tract surgery, Severe peritonitis after lower digestive tract surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
intravenous immunoglobulin
Primary Outcome Measure Information:
Title
clinical efficacy
Time Frame
at day 7
Secondary Outcome Measure Information:
Title
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,

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have obvious symptoms and observation of post-surgical peritonitis, and meet the criteria described bellow. Patients with >=38 degrees C, >=15,000/mm3 or <=3,000/mm3 of WBC and >=10mg/dL of CRP Patients who have no abscess on the abdominal image Patients who were administered antibacterial agents for 1 day or more, and show no sign of improvement Patients who are 20 years old or older Patients who have signed the agreement for participation in this study Exclusion Criteria: Patients who have a history of hypersensitivity to any of the ingredients of Immunoglobulin products Patients who have a history of shock due to any of the ingredients of Immunoglobulin products Patients who were administered immunoglobulin within 1 month before entry Patients who were administered antibacterial agents for 1 day or more, and show signs of improvement Patients with IgA deficiency Patients with hereditary fructose intolerance Patients with history of allergy or adverse effect for antibacterial agents Patients who have underlying or concomitant disease that may seriously affect the assessment of this study Patients who are or could be pregnant Patients who have noninfectious fever, fungal infection or viral illness Other patients who are judged to be inadequate to participate in this study by their physician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morito Monden, MD, PhD
Organizational Affiliation
Multicenter Clinical Study Group of Osaka
Official's Role
Study Chair
Facility Information:
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan

12. IPD Sharing Statement

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

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