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

Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group1 site in 1 country60 target enrollmentAugust 2007

ConditionsPeritonitis Postoperative Complications

Drugsintravenous immunoglobulin

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peritonitis
Sponsor: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Enrollment: 60
Locations: 1
Primary Endpoint: clinical efficacy
Status: Withdrawn
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

June 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

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

Outcomes

Primary Outcomes

clinical efficacy

Time Frame: at day 7

Secondary Outcomes

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,)