Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128180
Status:
COMPLETED
Last Update Posted:
2014-12-24
First Post:
2005-08-05
Brief Title:
Efficacy of Methylprednisolone for Hantavirus Cardiopulmonary Syndrome
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
A Phase II Randomized Double-Blind Placebo-Controlled Trial of Intravenous Methylprednisolone as a Treatment for Presumed Hantavirus Cardiopulmonary Syndrome
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 andor 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 PaO2FiO2 ratio less than or equal to 55 cardiac index less than or equal to 22 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 andor pressorinotropic 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 30 milligramsdeciliter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U19 A1045452 | None | None | None |