Intravenous Immunoglobulin in Combination Therapy With Antibacterial Agents for SSI of the Lower Digestive Tract
This study has been withdrawn prior to enrollment.
(No eligible patient.)
Sponsor:
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Information provided by:
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
ClinicalTrials.gov Identifier:
NCT00511212
First received: August 1, 2007
Last updated: July 20, 2011
Last verified: August 2007
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Purpose
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 | Intervention |
|---|---|
|
Peritonitis Postoperative Complications |
Drug: intravenous immunoglobulin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group:
Primary Outcome Measures:
- clinical efficacy [ Time Frame: 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 [ Time Frame: at day 3 and at the end of test drug administration, ]
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | June 2009 |
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- Other patients who are judged to be inadequate to participate in this study by their physician
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511212
Locations
| Japan | |
| Osaka University Hospital | |
| Suita, Osaka, Japan, 565-0871 | |
Sponsors and Collaborators
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Investigators
| Study Chair: | Morito Monden, MD, PhD | Multicenter Clinical Study Group of Osaka |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00511212 History of Changes |
| Other Study ID Numbers: | MCSGO-0701 |
| Study First Received: | August 1, 2007 |
| Last Updated: | July 20, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group:
|
severe peritonitis SSI lower digestive tract surgery Severe peritonitis after lower digestive tract surgery |
Additional relevant MeSH terms:
|
Peritonitis Postoperative Complications Peritoneal Diseases Digestive System Diseases Pathologic Processes Anti-Bacterial Agents Immunoglobulins Antibodies |
Immunoglobulins, Intravenous Rho(D) Immune Globulin Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013