GCIV as an Adjuvant Therapy for Community-Acquired Severe Sepsis or Septic Shock

This study has been terminated.
Sponsor:
Collaborator:
Symyoo
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01315496
First received: March 14, 2011
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

This study is to determine whether the intravenous application of 'Ⅳ-Globulin S inj. (Human Immunoglobulin G)' can reduce mortality in patients with severe sepsis or septic shock.


Condition Intervention Phase
Severe Sepsis
Septic Shock
Drug: Immunoglobulin G
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Randomized, Double-blind, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Administration of 'IV-Globulin S Inj.' in Adult Subjects With Community-Acquired Severe Sepsis or Septic Shock

Resource links provided by NLM:


Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 28th day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: 7th day ] [ Designated as safety issue: Yes ]
  • Course of SOFA subscores [ Time Frame: 5 Times: D-1, D1, D3, D5, D7 ] [ Designated as safety issue: Yes ]
  • Laboratory Test [ Time Frame: 7th Day ] [ Designated as safety issue: Yes ]
    sputum culture test, CBC, blood chemistry, blood coagulation test, CRP, ABGA

  • Duration of ICU and general ward admission [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 214
Study Start Date: October 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imunoglobulin G
The enrolled patients will be randomized to receive supplementation of IVIG in ICU within 48 hours after hospital arrival admission for 3 consecutive days.
Drug: Immunoglobulin G
Immunoglobulin 1.5-2g/Kg/3days
Other Name: GCIV
Placebo Comparator: Placebo control
The enrolled patients will be randomized to receive supplementation of placebo (0.9% NaCl) in ICU within 48 hours after hospital arrival admission for 3 consecutive days.
Drug: Immunoglobulin G
Immunoglobulin 1.5-2g/Kg/3days
Other Name: GCIV

Detailed Description:

A Placebo-controlled, Randomized, Double-blind, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Administration of 'IV-Globulin S inj.(Human Immunoglobulin G)' as an Adjuvant Therapy in Adult Subjects with Community-Acquired Severe Sepsis or Septic Shock.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with severe sepsis or septic shock, if all of the following criteria is satisfied.

    1. Age ≥ 18 years
    2. Proved or suspected infection in at least one site
  • pneumonia
  • urinary tract infection
  • intra-abdominal infection
  • primary bloodstream infection
  • skin and soft tissue infection 3. Three or more of the following
  • a core temperature ≥ 38° C or ≤ 36° C
  • a heart rate ≥ 90 beats/min
  • a respiratory rate ≥ 20 breaths/min or PaCO2 ≤ 32 mmHg or use of mechanical ventilation for an acute process
  • a white blood cell count ≥ 12000/mm3 or ≤ 4000/ mm3 or immature neutrophils > 10% 4. Acute organ failure in one or more of the following
  • kidney
  • respiratory system
  • blood system
  • metabolic system
  • circulatory system 5. APACHE score ≥ 20 and ≤ 29 6. Patient can treatment with GCIV in ICU within at least 48 hours 7. Informed consent

Exclusion Criteria:

  1. Pregnant or breast-feeding women
  2. a weight > 100kg
  3. discharged from the hospital at least 14 days prior to new admission
  4. Transferred from another hospital staying more than 48 hours
  5. allergy or shock of IVIG
  6. Treated with IVIG within the 12 weeks immediately preceding enrolment in this study
  7. IgA deficiency
  8. Hypernatremia or hyperhydration
  9. Proved or suspected HIV or AIDS patients(CD4+ <200mL)
  10. Current participation in any study within the last 4 weeks
  11. Do not resuscitate (DNR) status
  12. Patient's death is considered imminent due to coexisting disease
  13. physicians decision to exclude patients from this protocol
  14. Immunocompromised patients
  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: NCT01315496

Locations
Korea, Republic of
Korea University Ansan Hospital
Ansan, Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang, Korea, Republic of
Chungbuk National University Hospital
Cheongju, Korea, Republic of
Gachon University Gil Hospital
Incheon, Korea, Republic of
Gyrongsang National University Hospital
Jinju-si, Gyeongsangnam-do,, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
The Catholic of Korea Yeouido ST. Mary's Hospital
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Seoul Medical Center
Seoul, Korea, Republic of
Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Kangnam Sacred Heart Hospital
Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Ajuo University Hospital
Suwon, Korea, Republic of
Wonju Christian Hospital
Wonju, Korea, Republic of
Sponsors and Collaborators
Green Cross Corporation
Symyoo
Investigators
Principal Investigator: Min Ja Kim, Professor Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01315496     History of Changes
Other Study ID Numbers: GCIV_P3
Study First Received: March 14, 2011
Last Updated: April 29, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Green Cross Corporation:
Human Immunoglobulin G
Sepsis
Septic shock

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Immunoglobulin G
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014