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

Sponsor

Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00511212

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peritonitis Postoperative Complications	Drug: intravenous immunoglobulin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2007

Anticipated Study Completion Date :

Jun 1, 2009

Outcome Measures

Primary Outcome Measures

clinical efficacy [at day 7]

Secondary Outcome Measures

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,]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Other patients who are judged to be inadequate to participate in this study by their physician