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

Information source: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Peritonitis; Postoperative Complications

Intervention: intravenous immunoglobulin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Official(s) and/or principal investigator(s):
Morito Monden, MD, PhD, Study Chair, Affiliation: Multicenter Clinical Study Group of Osaka

Overall contact:
Mitsugu Sekimoto, MD, PhD, Phone: +81-6-6879-3251, Ext: 3251, Email: sekimoto@surg2.med.osaka-u.ac.jp

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.

Clinical Details

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: clinical efficacy

Secondary outcome: 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

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Mitsugu Sekimoto, MD, PhD, Phone: +81-6-6879-3251, Ext: 3251, Email: sekimoto@surg2.med.osaka-u.ac.jp

Osaka University Hospital, Suita, Osaka 565-0871, Japan; Recruiting
Mitsugu Sekimoto, MD, PhD, Phone: +81-6-6879-3251, Ext: 3251, Email: sekimoto@surg2.med.osaka-u.ac.jp
Masataka Ikeda, MD, PhD, Phone: +81-6-6879-3251, Ext: 3251, Email: mikeda@surg2.med.osaka-u.ac.jp
Additional Information

Starting date: August 2007
Ending date: June 2009
Last updated: August 2, 2007

Page last updated: February 12, 2009

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