Intravenous Immunoglobulin in Combination Therapy With Antibacterial Agents for SSI of the Lower Digestive Tract
NCT ID: NCT00511212
Last Updated: 2011-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
60 participants
INTERVENTIONAL
2007-08-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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intravenous immunoglobulin
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
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Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
OTHER
Principal Investigators
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Morito Monden, MD, PhD
Role: STUDY_CHAIR
Multicenter Clinical Study Group of Osaka
Locations
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Osaka University Hospital
Suita, Osaka, Japan
Countries
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Other Identifiers
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MCSGO-0701
Identifier Type: -
Identifier Source: org_study_id
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