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Gram-Negative Bacterial InfectionsNCT00563134

A Randomised Trial on the Saftely and Efficacy of GR270774 in the Treatment of Gram-negative Sepsis in Adult

A study testing GR270774 in people with Gram-Negative Bacterial Infections and Sepsis, run by Hospital Authority, Hong Kong at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

Sepsis sometimes occurs in people who have a serious infection. It is caused by toxic substances (toxins) from bacteria and other germs entering your bloodstream. Most people with sepsis will recover with routine medical care before the illness gets more serious. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gram-Negative Bacterial Infections, Sepsis
What is being tested?
GR270774
How many people
1,800 participants
Where
1 siteChina
Study dates
Oct 2005to Dec 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Who may be able to join

  • Subject is 18 years of age or over.
  • Subject has one of the following bacterial infections (as defined in Section 14.5) and a suspected or confirmed Gram-negative etiology:
  • Confirmed Gram-negative bacteremia (Gram-negative pathogen must be isolated from blood culture prior to study entry)
  • Intra-abdominal infection
  • Nosocomial pneumonia (Evidence of Gram-negative organism from histology or by direct stain of a respiratory specimen required prior to study entry)
  • Pyelonephritis
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  • Subject is receiving new parenteral antibacterial treatment for the suspected or confirmed Gram-negative infection believed to be responsible for this episode of sepsis. The subject must receive study drug within 36 hours of commencing treatment with this new antibacterial agent.
  • Note: Changes in antibiotic coverage made to treat the infection causing the current episode of sepsis or needed to treat a deteriorating subject in whom previous antibiotic coverage was deemed inadequate will be viewed as a new antibiotic.
  • Subject has signs of new-onset severe sepsis as evidenced by at least ONE of the following hypoperfusion abnormalities OR organ failures caused by the current episode of sepsis. Subject must receive study medication within 12 hours from onset of the first sepsis-related hypoperfusion abnormality or organ failure:
  • Persistent oliguria (urine output <0.5 mL/kg/hr for at least two hours after adequate volume resuscitation (ie, >=2 L isotonic crystalloid or appropriate colloid to achieve the same effect)) Note: This criterion does not apply to subjects with chronic renal insufficiency/failure.
  • Metabolic acidosis (either a pH <=7.3 or a base deficit >5 mmol/L and a blood lactate level >2X the upper limit of normal)
  • Respiratory failure: PaO2/FiO2 <200
  • Coagulopathy: acute sepsis-related changes in either platelet count (<100,000 cells/mm3) or INR (>1.5)
  • Cardiovascular failure: sustained hypotension requiring vasopressor support (dopamine >5 µg/kg/min, epinephrine, norepinephrine, phenylephrine or vasopressin at any dose if used to increase blood pressure) for >1 hour in subjects in whom volume resuscitation is believed to be adequate (ie, subject has received >=2 L isotonic crystalloid or appropriate colloid to achieve the same effect) Note: Where a hypoperfusion abnormality/organ failure definition requires a condition to persist for a specified period of time, the organ failure is not considered to exist until the condition specified by the definition is met. The 12 hour window for start of study drug begins when the criteria for the organ failure/hypoperfusion are fulfilled. For organ failure/hypoperfusion abnormality defined in terms of a laboratory result (ie, metabolic acidosis, respiratory failure, and coagulopathy) the criteria for the organ failure/hypoperfusion are considered to be fulfilled at the time the laboratory sample was drawn. Otherwise, the 12 hour window begins at the time the organ failure definition criteria are fulfilled (ie, persistent oliguria and cardiovascular failure). Organ failures occurring subsequent to subject randomization but prior to initiation of study drug infusion do not constitute a secondary endpoint. These are treated as organ failures at study entry and should be documented as such in the relevant CRF pages. The occurrence of a subsequent organ failure does not redefine the start of the 12 hour window for start of study drug. This period is defined above to begin at the onset of the first sepsis-related organ failure qualifying the subject for study entry.
  • Subject or their legally acceptable representative has provided written and dated informed consent to participate in the study.
  • Subject, if female of childbearing potential or less than one year post menopausal (including those who are practicing birth control and those with tubal ligations), has a negative urine pregnancy test (measuring human chorionic gonadotropin(HCG) result prior to enrollment.

Who cannot join

  • Subject is currently participating in or has participated in an investigational drug or medical device trial within 30 days or five half-lives, which ever is longer, prior to enrollment in this study.
  • 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/µL or expected to decline to <500/µL in the next 3 days).
  • Subject is known or believed to suffer from hereditary spherocytosis or S.E. Asian elliptocytosis.
  • 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).
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  • 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 hemoglobin level at screening <9.0 g/dL (5.59 mmol/L). This hemoglobin assessment should be based on the most recent available data in the subject's medical record at the time of screening and is not used in the assessment of the hemoglobin stopping rule described in Section 6.2.2.
  • 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 (eg, Intralipid), or systemic administration of amphotericin preparations (for example; amphotericin, liposomal amphotericin, or amphotericin B lipid complex).
  • Note: the use of topical amphotericin and oral amphotericin products are permitted and may be administered concomitantly with study drug at the discretion of the investigator.
  • Subject is pregnant (positive urine pregnancy test at baseline) or lactating.
  • Subject has previously been enrolled in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Kwong Wah Hospital

    Hong Kong

Other trials in China

About this study

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

Sepsis sometimes occurs in people who have a serious infection. It is caused by toxic substances (toxins) from bacteria and other germs entering your bloodstream. Most people with sepsis will recover with routine medical care before the illness gets more serious. However, in some people, sepsis does become more serious. This severe sepsis can cause damage to internal organs (such as your heart, lungs, kidneys, and liver) and can be life threatening. Special natural fats, (called 'lipoproteins') in our blood are thought to help protect us from the toxins produced by bacteria during sepsis. Levels of these lipoproteins are often low in people with sepsis and this may make it more difficult to recover from the disease. GR270773 is a new drug that has been developed to help the lipoproteins in protecting the body against toxins. GR270773 is made from purified fats and oils from the soyabean and does not contain cholesterol. This research study will test the safety (side effects) of GR270773 and whether or not it is effective in preventing complications in people with severe sepsis.

Being tested
GR270774
Keywords
Suspected or confirmed severe Gram-negative sepsis
Medical subject headings
Gram-Negative Bacterial Infections, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GR270774Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Measured: 28 days

Secondary outcomes (3)

  1. New onset organ failure

    Measured: 28 days

  2. Safety and tolerablity

    Measured: 28 days

  3. Long term mortality

    Measured: 3, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2007 (estimated)
  2. Study startOct 2005
  3. Study completionDec 2006 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
1,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00563134
Sponsor's protocol ID
KW/FR/04-018
Other IDs
HARECCTR0500030
Status last verified
Jul 2010
First submitted
21 Nov 2007
Last updated
7 Jul 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing GR270774 in people with Gram-Negative Bacterial Infections and Sepsis, run by Hospital Authority, Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00563134.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2010.

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