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

Postoperative Complications Clinical Trial

Official title:

Clinical Study of Intravenous Immunoglobulin (IVIG) in Combination Therapy With Antibacterial Agents for Surgical Site Infection of the Lower Digestive Tract

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00511212
• Other study ID #: MCSGO-0701
• Status: Withdrawn
• Phase: N/A
• First received: August 1, 2007
• Last updated: July 20, 2011
• Start date: August 2007
• Est. completion date: June 2009

Study information

• Verified date: August 2007
• Source: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 60
• Est. completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peritonitis
• Postoperative Complications

Intervention

Drug:
• intravenous immunoglobulin

Locations

Country	Name	City	State
Japan	Osaka University Hospital	Suita	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical efficacy		at day 7
Secondary	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		at day 3 and at the end of test drug administration,