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
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ClinicalTrials.gov Identifier: NCT01145560 |
Recruitment Status :
Completed
First Posted : June 16, 2010
Results First Posted : September 23, 2013
Last Update Posted : October 6, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Severe Sepsis Septic Shock | Drug: AZD9773 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, 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 |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |

Arm | Intervention/treatment |
---|---|
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 |
- Ventilator-free Days (VFDs) Over 28 Days [ Time Frame: Over 28 days following first dose ]Number of ventilator-free days (VFDs)
- 7-day Mortality [ Time Frame: Over 7 days following first dose ]Number of patients who died over 7 days
- 28-day Mortality [ Time Frame: Over 28 days following first dose ]Number of patients who died over 28 days
- Safety and Tolerability [ Time Frame: All study visits (over 90 days following first dose) ]Number of patients with treatment-emergent adverse events

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- Advanced human immunodeficiency virus (HIV) infection (CD4 ≤50/mm3).
- Stage III or IV cancer.
- Haemopoietic or lymphoreticular malignancies not in remission.
- Receiving radiation therapy or chemotherapy.
- Stem cell, organ or bone marrow transplant in the past 6 months.
- Absolute neutrophil count <500 per μL.
- High dose steroids or other immunocompromising drugs.
-
Concomitant diseases:
- Deep seated fungal infection or active tuberculosis.
- Cirrhosis with portal hypertension or Childs-Pugh Class C.
- History of chronic hypercarbia, respiratory failure in past 6 months or use of home oxygen in the setting of severe chronic respiratory disease.
- Neuromuscular disorders that impact breathing/spontaneous ventilation.
- Quadriplegia.
- Cardiac arrest in the past 30 days.
- New York Heart Association functional Class IV due to heart failure or any disorder.
- Burns over > 30% of body surface area.
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Medication and allergy disqualifications.
- Treatment with anti-TNF agents within the last 8 weeks.
- Previously received ovine derived products (CroFab™, DigiFab™).
- Sheep product allergy or allergy to latex, papain, chymopapain.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145560

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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01145560 |
Other Study ID Numbers: |
D0620C00003 |
First Posted: | June 16, 2010 Key Record Dates |
Results First Posted: | September 23, 2013 |
Last Update Posted: | October 6, 2014 |
Last Verified: | September 2014 |
severe sepsis TNF neutralisation septic shock patients |
Sepsis Toxemia Shock, Septic Shock |
Infections Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |