Status:
COMPLETED
Efficacy of Methylprednisolone for Hantavirus Cardiopulmonary Syndrome
Lead Sponsor:
University of New Mexico
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Hantavirus Infections
Eligibility:
All Genders
2+ years
Phase:
PHASE2
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 t...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- Onset of hypoxia (oxygen saturation less than or equal to 92% or requiring supplemental oxygen) one or more days after onset of symptoms, and
- 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:
- Febrile illness (subjective or documented) in the judgment of the enrolling investigator; and
- Headache or myalgia or at least one digestive symptom (nausea, diarrhea, vomiting, abdominal pain) and
- A platelet count less than 150,000 on peripheral smear; and
- Onset of hypoxia (oxygen saturation less than or equal to 92% or requiring supplemental oxygen) one or more days after onset of symptoms, and
- Development of bilateral pulmonary infiltrates on chest X-ray
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00128180
Start Date
January 1 2003
End Date
October 1 2011
Last Update
December 24 2014
Active Locations (1)
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1
Facultad de Medicina Clinica Alemana- Universidad del Desarrollo
Santiago, Chile