Trial Outcomes & Findings for 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 (NCT NCT01145560)

NCT ID: NCT01145560

Last Updated: 2014-10-06

Results Overview

Number of ventilator-free days (VFDs)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

300 participants

Primary outcome timeframe

Over 28 days following first dose

Results posted on

2014-10-06

Participant Flow

Subjects were screened and enrolled from approximately 100 centres worldwide.

Participant milestones

Participant milestones
Measure	AZD9773 250/50 Units/kg AZD9773 250/50 units/kg IV	AZD9773 500/100 Units/kg AZD9773 500/100 units/kg IV	Placebo Saline
Overall Study STARTED	100	100	100
Overall Study Received Treatment	99	98	99
Overall Study Completed Treatment	69	85	78
Overall Study COMPLETED	96	96	98
Overall Study NOT COMPLETED	4	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	AZD9773 250/50 Units/kg AZD9773 250/50 units/kg IV	AZD9773 500/100 Units/kg AZD9773 500/100 units/kg IV	Placebo Saline
Overall Study Withdrawal by Subject	2	1	0
Overall Study Lost to Follow-up	1	1	1
Overall Study No study drug by 24h after organ failure	1	0	0
Overall Study Accidental unblinding of study treatment	0	1	0
Overall Study False insurance information	0	1	0
Overall Study Withdrawal of therapy	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZD9773 250/50 Units/kg n=100 Participants AZD9773 250/50 units/kg IV	AZD9773 500/100 Units/kg n=100 Participants AZD9773 500/100 units/kg IV	Placebo n=100 Participants Saline	Total n=300 Participants Total of all reporting groups
Age, Continuous	64.4 years STANDARD_DEVIATION 15.76 • n=93 Participants	66.6 years STANDARD_DEVIATION 14.61 • n=4 Participants	64.1 years STANDARD_DEVIATION 15.25 • n=27 Participants	65.0 years STANDARD_DEVIATION 15.21 • n=483 Participants
Sex: Female, Male Female	40 Participants n=93 Participants	40 Participants n=4 Participants	32 Participants n=27 Participants	112 Participants n=483 Participants
Sex: Female, Male Male	60 Participants n=93 Participants	60 Participants n=4 Participants	68 Participants n=27 Participants	188 Participants n=483 Participants

PRIMARY outcome

Timeframe: Over 28 days following first dose

Population: Intention-to-treat analysis set

Number of ventilator-free days (VFDs)

Outcome measures

Outcome measures
Measure	AZD9773 250/50 Units/kg n=100 Participants AZD9773 250/50 units/kg IV	AZD9773 500/100 Units/kg n=100 Participants AZD9773 500/100 units/kg IV	Placebo n=100 Participants Saline
Ventilator-free Days (VFDs) Over 28 Days	21.0 Days Interval 0.0 to 28.0	17.5 Days Interval 0.0 to 28.0	19.0 Days Interval 0.0 to 28.0

SECONDARY outcome

Timeframe: Over 7 days following first dose

Population: Intention-to-treat analysis set

Number of patients who died over 7 days

Outcome measures

Outcome measures
Measure	AZD9773 250/50 Units/kg n=100 Participants AZD9773 250/50 units/kg IV	AZD9773 500/100 Units/kg n=100 Participants AZD9773 500/100 units/kg IV	Placebo n=100 Participants Saline
7-day Mortality	9 Participants	9 Participants	10 Participants

SECONDARY outcome

Timeframe: Over 28 days following first dose

Population: Intention-to-treat analysis set

Number of patients who died over 28 days

Outcome measures

Outcome measures
Measure	AZD9773 250/50 Units/kg n=100 Participants AZD9773 250/50 units/kg IV	AZD9773 500/100 Units/kg n=100 Participants AZD9773 500/100 units/kg IV	Placebo n=100 Participants Saline
28-day Mortality	15 Participants	27 Participants	20 Participants

SECONDARY outcome

Timeframe: All study visits (over 90 days following first dose)

Population: Safety Analysis Set

Number of patients with treatment-emergent adverse events

Outcome measures

Outcome measures
Measure	AZD9773 250/50 Units/kg n=100 Participants AZD9773 250/50 units/kg IV	AZD9773 500/100 Units/kg n=97 Participants AZD9773 500/100 units/kg IV	Placebo n=99 Participants Saline
Safety and Tolerability	86 Participants	87 Participants	92 Participants

Adverse Events

AZD9773 250/50 Units/kg

Serious events: 28 serious events

Other events: 74 other events

Deaths: 0 deaths

AZD9773 500/100 Units/kg

Serious events: 27 serious events

Other events: 71 other events

Deaths: 0 deaths

Placebo

Serious events: 31 serious events

Other events: 68 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Justin Lindemann

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	AZD9773 250/50 Units/kg n=100 participants at risk AZD9773 250/50 units/kg IV	AZD9773 500/100 Units/kg n=97 participants at risk AZD9773 500/100 units/kg IV	Placebo n=99 participants at risk Saline
Blood and lymphatic system disorders Anaemia	20.0% 20/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	18.6% 18/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	22.2% 22/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Blood and lymphatic system disorders Thrombocytopenia	5.0% 5/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	4.1% 4/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	4.0% 4/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Cardiac disorders Atrial Fibrillation	11.0% 11/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	14.4% 14/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	8.1% 8/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Gastrointestinal disorders Constipation	7.0% 7/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	11.3% 11/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	9.1% 9/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Gastrointestinal disorders Diarrhoea	12.0% 12/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	9.3% 9/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	14.1% 14/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Gastrointestinal disorders Nausea	5.0% 5/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	2.1% 2/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	7.1% 7/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Gastrointestinal disorders Vomiting	5.0% 5/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	2.1% 2/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	5.1% 5/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
General disorders Generalised Oedema	6.0% 6/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	2.1% 2/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	4.0% 4/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
General disorders Oedema	4.0% 4/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	2.1% 2/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	5.1% 5/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
General disorders Oedema Peripheral	3.0% 3/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	3.1% 3/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	5.1% 5/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
General disorders Pyrexia	6.0% 6/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	5.2% 5/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	5.1% 5/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Infections and infestations Pneumonia	5.0% 5/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	4.1% 4/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	7.1% 7/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Infections and infestations Urinary Tract Infection	2.0% 2/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	6.2% 6/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	7.1% 7/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Metabolism and nutrition disorders Fluid Overload	3.0% 3/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	5.2% 5/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	3.0% 3/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Metabolism and nutrition disorders Hyperglycaemia	2.0% 2/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	1.0% 1/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	5.1% 5/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Metabolism and nutrition disorders Hyperkalaemia	6.0% 6/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	3.1% 3/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	5.1% 5/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Metabolism and nutrition disorders Hypernatraemia	6.0% 6/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	3.1% 3/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	4.0% 4/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Metabolism and nutrition disorders Hypoalbuminaemia	4.0% 4/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	1.0% 1/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	5.1% 5/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Metabolism and nutrition disorders Hypoglycaemia	5.0% 5/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	5.2% 5/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	2.0% 2/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Metabolism and nutrition disorders Hypokalaemia	10.0% 10/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	9.3% 9/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	5.1% 5/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Metabolism and nutrition disorders Hypophosphataemia	5.0% 5/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	2.1% 2/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	6.1% 6/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Psychiatric disorders Agitation	6.0% 6/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	7.2% 7/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	8.1% 8/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Psychiatric disorders Anxiety	6.0% 6/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	1.0% 1/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	7.1% 7/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Psychiatric disorders Confusional State	7.0% 7/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	4.1% 4/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	5.1% 5/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Psychiatric disorders Insomnia	5.0% 5/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	3.1% 3/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	11.1% 11/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	6.0% 6/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	7.2% 7/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	4.0% 4/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Skin and subcutaneous tissue disorders Decubitus Ulcer	4.0% 4/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	5.2% 5/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	6.1% 6/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Skin and subcutaneous tissue disorders Rash	5.0% 5/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	3.1% 3/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	4.0% 4/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Vascular disorders Hypertension	5.0% 5/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	5.2% 5/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	7.1% 7/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.
Vascular disorders Hypotension	4.0% 4/100 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	5.2% 5/97 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.	5.1% 5/99 One patient received incorrect dose of AZD9773, which explains the difference between the 2 AZD9773 dose groups for the patients in the following tables for adverse events.