- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00128180
Efficacy of Methylprednisolone for Hantavirus Cardiopulmonary Syndrome
December 5, 2014 updated by: University of New Mexico
A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Methylprednisolone as a Treatment for Presumed Hantavirus Cardiopulmonary Syndrome
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 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 fibrillation; and number of serious adverse events determined by study investigators to be at least possibly related to study treatment.
For this endpoint researchers will report: the median number of serious adverse events and the proportion that experience one or more serious adverse events.
The secondary study endpoints include: to assist in defining the natural history of the disease but will not meaningfully affect treatment: Extracorporeal Membrane Oxygenation (ECMO); duration of intensive care unit stays; duration of hospital stays; duration of shock and/or pressor/inotropic support; length of time on mechanical ventilation; intubated and placed on a ventilator; refractory shock despite fluid resuscitation; and serum creatinine greater than or equal to 3.0 milligrams/deciliter.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Santiago, Chile
- Facultad de Medicina Clinica Alemana- Universidad del Desarrollo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
- 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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo
|
Active Comparator: Active
Methylprednisolone
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
28 days
|
|
Number of Participants With SAEs
Time Frame: 6 months
|
The Number of participants with SAEs
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants on Extracorporeal Membrane Oxygenation (ECMO)
Time Frame: 6 months
|
number of participants
|
6 months
|
Duration of ICU Stays
Time Frame: 6 months
|
6 months
|
|
Duration of Hospital Stay in Days
Time Frame: 6 months
|
Days
|
6 months
|
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.
|
6 months
|
Number of Participants Intubated and Placed on a Ventilator After Study Entry.
Time Frame: 6 months
|
Participants
|
6 months
|
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.
|
6 months
|
Length of Time on a Ventilator
Time Frame: 6 months
|
6 months
|
|
Development of Serum Creatinine Greater Than or Equal to 3.0 mg/dL After Study Entry
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pablo Vial, MD, Universidad del Desarrollo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
August 5, 2005
First Submitted That Met QC Criteria
August 5, 2005
First Posted (Estimate)
August 9, 2005
Study Record Updates
Last Update Posted (Estimate)
December 24, 2014
Last Update Submitted That Met QC Criteria
December 5, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Respiratory Insufficiency
- Bunyaviridae Infections
- Hantavirus Pulmonary Syndrome
- Hantavirus Infections
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
Other Study ID Numbers
- 01-010
- U19 A1045452
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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