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

Not Applicable

Withdrawn

• Conditions: Peritonitis; Postoperative Complications

• Registration Number: NCT00511212
• Lead Sponsor: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-08
• Study Start: 2007-08
• Study First Submitted: 2007-08-01
• Study First Submitted QC: 2007-08-02
• Study First Posted: 2007-08-03
• Study Completion: 2009-06
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
clinical efficacy	at day 7

Secondary Outcome Measures

Name	Time	Method
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,

Trial Locations

Locations (1)

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan