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
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peritonitis; Postoperative Complications
Intervention: intravenous immunoglobulin (Drug)
Phase: N/A
Status: Withdrawn
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
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Osaka University Hospital, Suita, Osaka 565-0871, Japan
Additional Information
Starting date: August 2007
Last updated: July 20, 2011
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