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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01145560




Registration number
NCT01145560
Ethics application status
Date submitted
7/06/2010
Date registered
16/06/2010
Date last updated
6/10/2014

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
D0620C00003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Sepsis 0 0
Septic Shock 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Injuries and Accidents 0 0 0 0
Poisoning
Blood 0 0 0 0
Other blood disorders
Infection 0 0 0 0
Other infectious diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD9773
Treatment: Drugs - Placebo

Experimental: 1 - AZD9773 250/50 units/kg

Experimental: 2 - AZD9773 500/100 units/kg

Placebo Comparator: 3 -


Treatment: Drugs: 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

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ventilator-free Days (VFDs) Over 28 Days
Timepoint [1] 0 0
Over 28 days following first dose
Secondary outcome [1] 0 0
7-day Mortality
Timepoint [1] 0 0
Over 7 days following first dose
Secondary outcome [2] 0 0
28-day Mortality
Timepoint [2] 0 0
Over 28 days following first dose
Secondary outcome [3] 0 0
Safety and Tolerability
Timepoint [3] 0 0
All study visits (over 90 days following first dose)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Blacktown
Recruitment hospital [2] 0 0
Research Site - Wollongong
Recruitment hospital [3] 0 0
Research Site - Herston
Recruitment hospital [4] 0 0
Research Site - Nambour
Recruitment hospital [5] 0 0
Research Site - Woollongabba
Recruitment hospital [6] 0 0
Research Site - Adelaide
Recruitment hospital [7] 0 0
Research Site - Clayton
Recruitment hospital [8] 0 0
Research Site - Footscray
Recruitment hospital [9] 0 0
Research Site - Fremantle
Recruitment postcode(s) [1] 0 0
- Blacktown
Recruitment postcode(s) [2] 0 0
- Wollongong
Recruitment postcode(s) [3] 0 0
- Herston
Recruitment postcode(s) [4] 0 0
- Nambour
Recruitment postcode(s) [5] 0 0
- Woollongabba
Recruitment postcode(s) [6] 0 0
- Adelaide
Recruitment postcode(s) [7] 0 0
- Clayton
Recruitment postcode(s) [8] 0 0
- Footscray
Recruitment postcode(s) [9] 0 0
- Fremantle
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Genk
Country [4] 0 0
Belgium
State/province [4] 0 0
Godinne
Country [5] 0 0
Belgium
State/province [5] 0 0
Liege
Country [6] 0 0
Belgium
State/province [6] 0 0
Ottignies
Country [7] 0 0
Canada
State/province [7] 0 0
Alberta
Country [8] 0 0
Canada
State/province [8] 0 0
British Columbia
Country [9] 0 0
Canada
State/province [9] 0 0
Manitoba
Country [10] 0 0
Canada
State/province [10] 0 0
Nova Scotia
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Hradec Kralove
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Praha
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Usti Nad Labem
Country [16] 0 0
Finland
State/province [16] 0 0
Kuopio
Country [17] 0 0
Finland
State/province [17] 0 0
Tampere
Country [18] 0 0
France
State/province [18] 0 0
Angers
Country [19] 0 0
France
State/province [19] 0 0
Dijon
Country [20] 0 0
France
State/province [20] 0 0
La Roche Sur Yon
Country [21] 0 0
France
State/province [21] 0 0
Limoges
Country [22] 0 0
France
State/province [22] 0 0
Montauban
Country [23] 0 0
France
State/province [23] 0 0
Nantes
Country [24] 0 0
France
State/province [24] 0 0
Nimes
Country [25] 0 0
France
State/province [25] 0 0
Orleans
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
France
State/province [27] 0 0
Poitiers
Country [28] 0 0
France
State/province [28] 0 0
Saint-michel
Country [29] 0 0
France
State/province [29] 0 0
Toulon
Country [30] 0 0
France
State/province [30] 0 0
Toulouse
Country [31] 0 0
France
State/province [31] 0 0
Tours
Country [32] 0 0
France
State/province [32] 0 0
Vandoeuvre Les Nancy
Country [33] 0 0
Spain
State/province [33] 0 0
Asturias
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Cataluna
Country [36] 0 0
Spain
State/province [36] 0 0
Comunidad Valenciana
Country [37] 0 0
Spain
State/province [37] 0 0
Coruna
Country [38] 0 0
Spain
State/province [38] 0 0
Islas Baleares
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01145560
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gordon Bernard, MD
Address 0 0
Vanderbilt University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01145560