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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01315496
• Date of registration: 14/03/2011
• Prospective Registration: No
• Primary sponsor: Green Cross Corporation
• Public title: GCIV as an Adjuvant Therapy for Community-Acquired Severe Sepsis or Septic Shock
• Scientific 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
• Date of first enrolment: October 2009
• Target sample size: 214
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01315496
• 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
• Phase: Phase 3

Countries of recruitment

Korea, Republic of

Contacts

• Name: Min Ja Kim, Professor
• Affiliation: Korea University Anam Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Septic Shock

Severe Sepsis

Intervention(s)

Drug: Immunoglobulin G

Primary Outcome(s)

All cause mortality [Time Frame: 28th day]

Secondary Outcome(s)

All cause mortality [Time Frame: 7th day]

Course of SOFA subscores [Time Frame: 5 Times: D-1, D1, D3, D5, D7]

Duration of ICU and general ward admission [Time Frame: 28 days]

Laboratory Test [Time Frame: 7th Day]

Secondary ID(s)

GCIV_P3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Symyoo