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


N/A
20 Years
N/A
Not Enrolling
Both
Peritonitis, Postoperative Complications

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

clinical efficacy

Outcome Time Frame:

at day 7

Principal Investigator

Morito Monden, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Multicenter Clinical Study Group of Osaka

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

MCSGO-0701

NCT ID:

NCT00511212

Start Date:

August 2007

Completion Date:

June 2009

Related Keywords:

  • Peritonitis
  • Postoperative Complications
  • severe peritonitis
  • SSI
  • lower digestive tract surgery
  • Severe peritonitis after lower digestive tract surgery
  • Peritonitis
  • Postoperative Complications

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