Back to Rare Disease
This trial is complete. It is no longer accepting participants.

NCT00004494

NCT00004494
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with adult respiratory distress syndrome (ARDS) along with sepsis (a serious body-wide response to infection).
  • Your ARDS involves low oxygen levels that do not improve with extra oxygen, widespread changes seen on chest imaging, no heart-related cause for fluid in the lungs, and reduced lung function (confirm with trial site).
  • Your sepsis involves two or more of the following signs: fever or abnormally low body temperature; fast heart rate; fast breathing; abnormal white blood cell count; low blood pressure; suspected infection; or signs that organs are not working properly, such as sudden confusion, unexplained blood acidity, very low urine output for more than 2 hours, unexpected blood clotting problems, or sudden rise in liver-related values (confirm with trial site).
  • It has been at least 30 days since you last took part in any other research trial.

Who may not be able to join:

  • Your sepsis is causing dangerously unstable blood pressure.
  • You are currently taking part in another research trial.
  • You have needed 4 or more blood transfusions in the past 24 hours due to uncontrolled bleeding.
  • Your low white blood cell count is caused by chemotherapy.
  • You have severe liver disease with high blood pressure in the liver's blood vessels.
  • Your kidneys are producing almost no urine (less than 50 mL per day).
  • You are in cardiogenic shock (your heart is not pumping enough blood).
  • You have recently had a stroke, head injury, or dangerously high pressure in your skull.
  • You have another serious neurological (brain or nerve) condition.
  • You are pregnant.
  • You have AIDS (HIV-related immune deficiency).
  • Your immune system is suppressed due to an organ transplant.
  • You have severe burns.
  • You have an underlying condition that is expected to be fatal very soon regardless of treatment.
  • You are severely obese (confirm with trial site for specific definition).
  • You have had diarrhea recently.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 1
Sponsor
Stony Brook University
Registry
clinicaltrials_gov
Start date
1 September 1998

Where this trial is recruiting

🇺🇸 United States

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov