Efficacy of Methylprednisolone for Hantavirus Cardiopulmonary Syndrome
Condition: Hantavirus Infections
MeSH terms: Hantavirus Pulmonary Syndrome; Hantavirus Infections
Intervention: Methylprednisolone; Placebo
Intervention description: Intravenous methylprednisolone 16 mg/kg/day for 3 days as follows: 8 mg/kg (up to 500 mg) given over first hour followed by 8 mg/kg over the next 23 hours; then 16 mg/kg (up to 1000 mg) on days 2 and 3 administered over 24 hours.; Placebo
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: hantaviruses, methylprednisolone, cardiopulmonary syndrome

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.
    

Eligibility criteria:

        Inclusion Criteria:

        Informed consent is given by patient or guardian.

        And one of the following:

          -  Confirmed diagnosis: Positive hantavirus IgM assay or detection of hantavirus in
             plasma or serum by RT-PCR in the presence of an acute febrile illness of less than 12
             days duration, and

               1. Onset of hypoxia (oxygen saturation less than or equal to 92% or requiring
                  supplemental oxygen) one or more days after onset of symptoms, and

               2. Development of pulmonary infiltrates on chest X-ray. OR

          -  Presumptive diagnosis: The presumptive diagnosis of acute hantavirus disease of less
             than 12 days duration with:

               1. Febrile illness (subjective or documented) in the judgment of the enrolling
                  investigator; and

               2. Headache or myalgia or at least one digestive symptom (nausea, diarrhea,
                  vomiting, abdominal pain) and

               3. A platelet count less than 150,000 on peripheral smear; and

               4. Onset of hypoxia (oxygen saturation less than or equal to 92% or requiring
                  supplemental oxygen) one or more days after onset of symptoms, and

               5. Development of bilateral pulmonary infiltrates on chest X-ray

        Exclusion Criteria:

          -  Age less than 2 years.

          -  If presumptive diagnosis is the inclusion criteria: subjects with a likely diagnosis
             other than hantavirus infection, including any positive culture or direct test for
             respiratory viruses (e.g., influenza, RSV, etc) or group A Streptococcus in a person
             with an illness compatible with streptococcal pharyngitis, a positive culture from a
             normally sterile site, or a presentation consistent with bacterial pneumonia.

          -  Immunocompromised patients at risk of opportunistic infection (e.g., patients with HIV
             infection, underlying malignancy, or who have received chemotherapy or
             immunosuppressive drugs within 30 days.)

          -  Patients who have or will receive any systemic antiviral medication (other than
             acyclovir, famciclovir, amantadine or rimantadine), systemic corticosteroids
             equivalent to approximately 0.5mg/kg prednisone, or any investigational drug within 30
             days before enrollment or during treatment.

          -  Any period of extreme bradycardia, pulseless electric activity

          -  Active GI bleeding, with hematemesis, melena or hematochezia or documented by upper or
             lower endoscopy or by gastric aspiration.