Overview

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

Status:
Withdrawn

Trial end date:
2009-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Treatments:

Anti-Bacterial Agents
Antibodies
gamma-Globulins
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin

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