Intravenous Immunoglobulin in Combination Therapy With Antibacterial Agents for SSI of the Lower Digestive Tract

NCT00511212 | Withdrawn DMC

• 1 other identifier: MCSGO-0701
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peritonitis; Postoperative Complications

Keywords

severe peritonitis; SSI; lower digestive tract surgery; Severe peritonitis after lower digestive tract surgery

Outcome Measures

Primary Outcomes (1)

• clinical efficacy

  at day 7

Secondary Outcomes (1)

• 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

  at day 3 and at the end of test drug administration,

Interventions

intravenous immunoglobulin DRUG

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group: lead

Study Sites (1)

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

MeSH Terms

Conditions

Peritonitis; Postoperative Complications

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Morito Monden, MD, PhD

  Multicenter Clinical Study Group of Osaka

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 1, 2007
• First Posted: August 3, 2007
• Study Start: August 1, 2007
• Study Completion: June 1, 2009
• Last Updated: July 21, 2011

Record last verified: 2007-08

Locations

JP (1)