A Study to Compare the Efficacy and Safety of 2 Dosing Regimens of IV Infusions of AZD9773 (CytoFab™) With Placebo in Adult Patients With Severe Sepsis and/or Septic Shock - Full Text View

Purpose

The primary purpose of this study to evaluate the effect of two different doses of AZD9773 (CytoFab™) versus placebo on ventilator free days (VFDs) over the first 28 days after the start of dosing with AZD9773 in patients with severe sepsis and/or septic shock, who are already receiving appropriate standard of care treatment for sepsis.

Condition	Intervention	Phase
Severe Sepsis Septic Shock	Drug: AZD9773 Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A MultiCentre, Randomized, Double-blind, Placebo-controlled Phase IIb Study to Compare the Efficacy and Safety of Two Dosing Regimens of Intravenous Infusions of AZD9773 (CytoFab™) in Adult Patients With Severe Sepsis and/or Septic Shock

Resource links provided by NLM:

MedlinePlus related topics: Sepsis Shock

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Ventilator-free Days (VFDs) Over 28 Days [ Time Frame: Over 28 days following first dose ] [ Designated as safety issue: No ]
Number of ventilator-free days (VFDs)

Secondary Outcome Measures:

7-day Mortality [ Time Frame: Over 7 days following first dose ] [ Designated as safety issue: Yes ]
Number of patients who died over 7 days
28-day Mortality [ Time Frame: Over 28 days following first dose ] [ Designated as safety issue: Yes ]
Number of patients who died over 28 days
Safety and Tolerability [ Time Frame: All study visits (over 90 days following first dose) ] [ Designated as safety issue: Yes ]
Number of patients with treatment-emergent adverse events


Enrollment:	300
Study Start Date:	October 2010
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 AZD9773 250/50 units/kg	Drug: AZD9773 A single loading dose following by up to 9 maintenance doses; doses to be given every 12 hours over a period of 5 days Other Name: CytoFab™
Experimental: 2 AZD9773 500/100 units/kg	Drug: AZD9773 A single loading dose following by up to 9 maintenance doses; doses to be given every 12 hours over a period of 5 days Other Name: CytoFab™
Placebo Comparator: 3	Drug: Placebo Placebo

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults with a first episode of sepsis during this hospitalisation and objective evidence of infection that requires parenteral antibiotics.
At least 2 of 4 SIRS criteria in the 24 hours before organ dysfunction (must include either fever OR elevated white blood cells [WBC])
Cardiovascular or respiratory dysfunction.

Exclusion Criteria:

Immunocompromising comorbidities or concomitant medications:
1. Advanced human immunodeficiency virus (HIV) infection (CD4 ≤50/mm3).
2. Stage III or IV cancer.
3. Haemopoietic or lymphoreticular malignancies not in remission.
4. Receiving radiation therapy or chemotherapy.
5. Stem cell, organ or bone marrow transplant in the past 6 months.
6. Absolute neutrophil count <500 per μL.
7. High dose steroids or other immunocompromising drugs.
Concomitant diseases:
1. Deep seated fungal infection or active tuberculosis.
2. Cirrhosis with portal hypertension or Childs-Pugh Class C.
3. History of chronic hypercarbia, respiratory failure in past 6 months or use of home oxygen in the setting of severe chronic respiratory disease.
4. Neuromuscular disorders that impact breathing/spontaneous ventilation.
5. Quadriplegia.
6. Cardiac arrest in the past 30 days.
7. New York Heart Association functional Class IV due to heart failure or any disorder.
8. Burns over > 30% of body surface area.
Medication and allergy disqualifications.
1. Treatment with anti-TNF agents within the last 8 weeks.
2. Previously received ovine derived products (CroFab™, DigiFab™).
3. Sheep product allergy or allergy to latex, papain, chymopapain.

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: NCT01145560

Show 52 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Principal Investigator:	Gordon Bernard, MD	Vanderbilt University
Study Director:	Warren Botnick, MD	Parexel
Study Director:	Justin Lindemann, MD	AstraZeneca
Study Director:	Wayne Dankner, MD	Parexel
Study Director:	Jiri Juchelka, MD	Parexel

More Information

Additional Information:

CSR-D0620C00003.pdf This link exits the ClinicalTrials.gov site

redacted-CSP-D0620C00003.pdf This link exits the ClinicalTrials.gov site


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01145560 History of Changes
Other Study ID Numbers:	D0620C00003
Study First Received:	June 7, 2010
Results First Received:	July 19, 2013
Last Updated:	September 26, 2014
Health Authority:	United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Federal Agency for Medicinal Products and Health Products Canada: Canadian Institutes of Health Research France: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Spain: Ministry of Health

Keywords provided by AstraZeneca:


severe sepsis TNF neutralisation septic shock patients

Additional relevant MeSH terms:


Sepsis Toxemia Shock Shock, Septic	Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes

ClinicalTrials.gov processed this record on September 27, 2016