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

Green Cross Corporation

Status and phase: Terminated; Phase 3

Conditions: Severe Sepsis; Septic Shock

Treatments: Drug: Immunoglobulin G

Study type: Interventional

Funder types: Industry

Identifiers

NCT01315496

GCIV_P3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 214 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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214 participants in 2 patient groups, including a placebo group

Imunoglobulin G

Experimental group

Description:

The enrolled patients will be randomized to receive supplementation of IVIG in ICU within 48 hours after hospital arrival admission for 3 consecutive days.

Treatment:

Drug: Immunoglobulin G

Placebo control

Placebo Comparator group

Description:

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.

Treatment:

Drug: Immunoglobulin G