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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00089986




Registration number
NCT00089986
Ethics application status
Date submitted
18/08/2004
Date registered
23/08/2004
Date last updated
21/08/2017

Titles & IDs
Public title
GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults
Scientific title
A Prospective, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multi-Center Study of the Safety and Efficacy of Three Days Continuous Intravenous Infusion of GR270773 in the Treatment of Suspected or Confirmed Gram-negative Severe Sepsis in Adults
Secondary ID [1] 0 0
EMD20001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Intravenous GR270773- Phospholipid Emulsion
Other interventions - Placebo

Treatment: Drugs: Intravenous GR270773- Phospholipid Emulsion


Other interventions: Placebo


Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With 28-Day All Cause Mortality - Mortality was assessed by the number of participants who died between days 1 and 28. A summary of death details was given which included whether the participant died between days 1 and 28, whether the death was related sepsis, cause of death, the source of the information, and whether the cause of death was verified by a death record. Participants who had withdrawn from study and all study assessments and for whom survival at day 28 could not be confirmed was treated as deaths for the primary endpoint. The difference in all-cause 28-day mortality rates for each treatment group versus the placebo group in the ITT Population was calculated as placebo - treatment.
Timepoint [1] 0 0
Day 1 (post-infusion) up to Day 28 Follow-up
Secondary outcome [1] 0 0
Number of Participants With New Onset Organ Failure, Regardless of Cause, Occurring During the 28 Days Post Enrollment in an Organ Not in Failure at Enrolment - The new onset organ failure was defined as first time each of the following criteria were met after start of study medication up to Day 28. Respiratory failure: defined by requiring mechanical ventilation not less than 24 hours due to surgery. Renal failure: defined by requiring the initiation of hemodialysis or hemofiltration. Coagulopathy: defined by disseminated intravascular coagulation (DIC) requiring transfusion with platelets or fresh frozen plasma or anticoagulant therapy. Cardiovascular failure: defined by sustained hypotension requiring vasopressor support of dopamine >5 microgram per kilogram per minute (µg/kg/min), epinephrine, norepinephrine, phenylephrine or vasopressin at any dose if used to increase blood pressure for >=6 continuous h. Analysis was done treating the death as a new onset organ failure (counted in both the numerator and denominator).
Timepoint [1] 0 0
Baseline (Day 1, pre-infusion) up to Day 28 Follow-up
Secondary outcome [2] 0 0
Number of Participants With New Onset Organ Failure of Respiratory Failure, Cardiovascular Failure, Renal Failure and Coagulopathy, Regardless of Cause, Occurring During the 28 Days Post Enrollment in an Organ Not in Failure at Enrollment - Respiratory failure: defined by requiring mechanical ventilation not less than 24 hours due to surgery. Renal failure: defined by requiring the initiation of hemodialysis or hemofiltration. Coagulopathy: defined by disseminated intravascular coagulation (DIC) requiring transfusion with platelets or fresh frozen plasma or anticoagulant therapy. Cardiovascular failure: defined by sustained hypotension requiring vasopressor support of dopamine >5 microgram per kilogram per minute (µg/kg/min), epinephrine, norepinephrine, phenylephrine or vasopressin at any dose if used to increase blood pressure for >=6 continuous h. For each organ failure type and the number of new onset organ failures per participants for each organ failure type, the denominator only included participants who did not have that type of organ failure at Baseline. At Baseline a participant could enter the study with a type of organ failure, that type of failure was not reported as a new onset organ failure.
Timepoint [2] 0 0
Baseline (Day 1, pre-infusion) up to Day 28 Follow up
Secondary outcome [3] 0 0
Assessment of Safety/Tolerability by Determining the Number of Participants With Any Adverse Events (AE), Serious Adverse Events (SAE) and Fatal SAE - An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition or common toxicity criteria (CTC) grade 4 laboratory abnormalities of national cancer institute not associated with the underlying sepsis unless more severe than expected for the participants condition.
Timepoint [3] 0 0
Day 1 (pre-infusion) up to Day 28 Follow-up

Eligibility
Key inclusion criteria
Inclusion criteria:

- Receiving parenteral antibiotic therapy for a suspected or confirmed Gram-negative
infection.

- Have at least one new hypoperfusion abnormality or at least one new onset organ
failure resulting from the current septic episode.

- Must be available and able to receive the first dose of study medication no more than
12 hours after the confirmation of a new hypoperfusion abnormality or new onset organ
failure and within 36 hours after the initiation of new parenteral antibacterial
therapy for the suspected or confirmed Gram-negative infection believed to be
responsible for this episode of sepsis.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Subject is unlikely to remain in hospital for a minimum of three days (72 hours)
following enrollment.

- Subject has neutropenia (e.g., subject recently receiving cytotoxic chemotherapy with
absolute neutrophil count <500/mcL or expected to decline to <500/mcL in the next 3
days).

- Subject has known active hemolytic disease, immune hemolytic anemias,
hemoglobinopathies (sickle cell anemia and thalassemia major).

- Subject has a known bone marrow disorder of inadequate red cell production (eg,
aplastic anemia, myelodysplasia).

- Subject is at increased risk of complications from GR270773-related hemolysis due to
the inability to increase cardiac function sufficiently to meet the demands for oxygen
delivery.

- Subject has a baseline hemoglobin (measured after adequate volume resuscitation) <9.0
g/dL (5.59 mmol/L).

- Subject is currently being treated with XIGRIS (Drotrecogin alfa (activated)) or its
use is considered imminent (ie., a decision to treat with XIGRIS has been made).

- Subject has a history of allergic reaction to eggs (or egg products), soybeans,
INTRALIPID, or any component of GR270773.

- Subject has been designated as 'not full support do not resuscitate' (DNR), or other
equivalent status which prohibits the use of life supporting interventions (e.g.,
mechanical ventilation, dialysis/hemofiltration, or others) thereby limiting the
treatment options available.

Note: Subjects with advanced directives prohibiting only chest compression (CPR) are
eligible for the study.

- Subject has preexisting severe liver disease such as cirrhosis, primary biliary
cirrhosis or known preexisting Child-Pugh class B or C liver dysfunction.

- Subject is moribund (a state in which death is perceived to be imminent) or has a life
expectancy of less than 3 months due to an underlying disease.

- Subject is currently receiving one of the following prohibited concomitant
medications; parenteral nutrition supplements containing lipid emulsions (e.g.,
INTRALIPID), amphotericin, liposomal amphotericin, or amphotericin B lipid complex.

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?



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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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GSK Investigational Site - St Leonards
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2065 - St Leonards
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3011 - Footscray
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3084 - Heidelberg
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6009 - Nedlands
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6959 - Fremantle
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Country [195] 0 0
United Kingdom
State/province [195] 0 0
Aberdeenshire
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Berkshire
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Lanarkshire
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Lancashire
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Merseyside
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Oxfordshire
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Somerset
Country [202] 0 0
United Kingdom
State/province [202] 0 0
West Lothian
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Leeds
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Sheffield

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective is to estimate the size of the GR270773 treatment effect on 28-day
all-cause mortality for two doses of GR270773 versus placebo in adult subjects with suspected
or confirmed Gram-negative severe sepsis. GR270773 will be administered as a three-day
continuous intravenous infusion.
Trial website
https://clinicaltrials.gov/show/NCT00089986
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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
Other publications