Clinical trial NCT01315496: GCIV as an Adjuvant Therapy for Community-Acquired Severe Sepsis or Septic Shock
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Severe Sepsis
Septic Shock
Keywords: Human Immunoglobulin G
Sepsis
Septic shock
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
Collaborators: name: Symyoo
First posted: 2011-03-15
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: All cause mortality
timeFrame: 28th day
Secondary outcomes:
measure: All cause mortality
timeFrame: 7th day
measure: Course of SOFA subscores
timeFrame: 5 Times: D-1, D1, D3, D5, D7
measure: Laboratory Test
timeFrame: 7th Day
measure: Duration of ICU and general ward admission
timeFrame: 28 days
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Jinju-si, Gyeongsangnam-do,
country: Korea, Republic of
facility: Gyrongsang National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic of Korea Yeouido ST. Mary's Hospital
city: Suwon
country: Korea, Republic of
facility: Ajuo University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Min Ja Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References: