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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This study has been withdrawn prior to enrollment.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:
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
  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.

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Digestive System Diseases
Infection
Intraabdominal Infections
Pathologic Processes
Peritoneal Diseases
Anti-Bacterial Agents
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Anti-Infective Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014