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

Septic Shock Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01315496
• Other study ID #: GCIV_P3
• Status: Terminated
• Phase: Phase 3
• First received: March 14, 2011
• Last updated: April 29, 2013
• Start date: October 2009
• Est. completion date: December 2013

Study information

• Verified date: April 2013
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 214
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Severe Sepsis
• Shock
• Shock, Septic
• Toxemia

Intervention

Drug:
• Immunoglobulin G
Immunoglobulin 1.5-2g/Kg/3days

Locations

Country	Name	City	State
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	Asan Medical Center	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul Medical Center	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	The Catholic of Korea Yeouido ST. Mary's Hospital	Seoul
Korea, Republic of	Ajuo University Hospital	Suwon
Korea, Republic of	Wonju Christian Hospital	Wonju

Sponsors (2)

Lead Sponsor	Collaborator
Green Cross Corporation	Symyoo

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		28th day	Yes
Secondary	All cause mortality		7th day	Yes
Secondary	Course of SOFA subscores		5 Times: D-1, D1, D3, D5, D7	Yes
Secondary	Laboratory Test	sputum culture test, CBC, blood chemistry, blood coagulation test, CRP, ABGA	7th Day	Yes
Secondary	Duration of ICU and general ward admission		28 days	Yes