Last updated: 07/17/2024 17:48:05
GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Percentage of participants with 28-Day all cause mortality
Timeframe: Day 1 (post-infusion) up to Day 28 Follow-up
Secondary outcomes:
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
Timeframe: Baseline (Day 1, pre-infusion) up to Day 28 Follow-up
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
Timeframe: Baseline (Day 1, pre-infusion) up to Day 28 Follow up
Assessment of safety/tolerability by determining the number of participants with any adverse events (AE), serious adverse events (SAE) and fatal SAE
Timeframe: Day 1 (pre-infusion) up to Day 28 Follow-up
Interventions:
Drug: Intravenous GR270773- Phospholipid Emulsion
Other: Placebo
Enrollment:
1415
Observational study model:
Not applicable
Primary completion date:
2007-15-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Sepsis
Product
GR270773
Collaborators
Not applicable
Study date(s)
September 2004 to April 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 years - 0 Not applicable
Accepts healthy volunteers
No
- 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.
- 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).
Inclusion and exclusion 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.
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.
Trial location(s)
Location
GSK Investigational Site
Bangalore, India, 560034
3.9 miles (6.2 km) away from your location
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-15-04
Actual study completion date
2007-15-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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