Clinical Trial: Efficacy of Methylprednisolone for Hantavirus Cardiopulmonary Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Methylprednisolone as a Treatment for Presumed Hantavirus Cardiopulmonary Syndrome

Brief Summary: The purpose of this study is to see if a drug, called methylprednisolone, is safe and effective in people with Hantavirus infection. Individuals 2 years of age or older are invited to participate in this study if their doctor suspects or knows they have Hantavirus infection. Volunteers will either be given methylprednisolone or placebo (contains no medication) through a needle inserted in a vein for 3 days. During the first 7 days of hospitalization procedures may include blood tests, physical exams, chest x-rays, and urine tests. During study visits on days 14, 28, 84 and 180 after diagnosis, the doctors will ask about health, examine the body, take a chest X-ray, collect blood for safety testing and for measuring antibodies, and do breathing tests on volunteers. Participants will be involved in the study for about 6 months.

Detailed Summary: This study is a phase II, randomized, double-blind, placebo-controlled evaluation of intravenous methylprednisolone versus placebo in treatment of hantavirus cardiopulmonary syndrome (HCPS). Patients with suspected or known hantavirus will be randomized to receive intravenous methylprednisolone or placebo over 3 days. Following the completion of this acute phase therapy, patients will be seen for follow up visits on days 14, 28, 84 and 6 months after study entry. Follow up visits will include a physical examination, including vital signs. In addition, blood will be drawn for a blood count, clinical chemistries, and quantitative polymerase chain reaction (day 14). Since Hantavirus pathogenesis involves the pulmonary system, other tests to be performed include chest x ray (day 28) and spirometry (days 28 and 180). The study will require 60 subjects with confirmed Hantavirus infection. Study subjects will include males and females greater than or equal to 2 years of age suspected of having Hantavirus disease. The enrolling co investigator must feel that Hantavirus disease is likely on the basis of the clinical syndrome. The primary study objectives are to: assess the efficacy of intravenous methylprednisolone in reducing the severity of HCPS and assess the safety of methylprednisolone in persons with suspected and proven Hantavirus infection. The secondary objectives are to: assess the impact of therapy on viremia and assess whether measurement of neutralizing antibody titers at entry or Human Leukocyte Antigen (HLA) typing can identify subgroups with increased risk of severe disease and/or death and whether therapy is effective in these subgroups. The primary endpoints will include: the proportion of subjects who develop one or more of the following critical events associated with severe disease 28 days after study entry: death, PaO2/FiO2 ratio less than or equal to 55, cardiac index less than or equal to 2.2, pulseless electrical activity, ventricular tachycardia or
Sponsor: University of New Mexico

Current Primary Outcome:

  • The Proportion of Subjects Who Develop Death, PaO2/FiO2 Ratio Less Than or Equal to 55, Cardiac Index Less Than or Equal to 2.2, Pulseless Electrical Activity, Ventricular Tachycardia or Fibrillation [ Time Frame: 28 days ]
  • Number of Participants With SAEs [ Time Frame: 6 months ]
    The Number of participants with SAEs


Original Primary Outcome:

Current Secondary Outcome:

  • Number of Participants on Extracorporeal Membrane Oxygenation (ECMO) [ Time Frame: 6 months ]
    number of participants
  • Duration of ICU Stays [ Time Frame: 6 months ]
  • Duration of Hospital Stay in Days [ Time Frame: 6 months ]
    Days
  • Duration of Shock and/or Pressor/Inotropic Support [ Time Frame: 6 months ]
    Pressor/inotropic support refers to the use of adrenaline-like medications to maintain blood pressure and cardiac output.
  • Number of Participants Intubated and Placed on a Ventilator After Study Entry. [ Time Frame: 6 months ]
    Participants
  • Number of Participants Who Developed Refractory Shock Despite Fluid Resuscitation After Study Entry [ Time Frame: 6 months ]
    Refractory shock refers to shock that persists despite fluid resucitation. Fluid resusitation refers to administration of intravenous fluids to maintain blood pressure and cardiac output.
  • Length of Time on a Ventilator [ Time Frame: 6 months ]
  • Development of Serum Creatinine Greater Than or Equal to 3.0 mg/dL After Study Entry [ Time Frame: 6 months ]


Original Secondary Outcome:

Information By: University of New Mexico

Dates:
Date Received: August 5, 2005
Date Started: January 2003
Date Completion:
Last Updated: December 5, 2014
Last Verified: December 2014