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Efficacy of Methylprednisolone for Hantavirus Cardiopulmonary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00128180
Recruitment Status : Completed
First Posted : August 9, 2005
Results First Posted : July 10, 2012
Last Update Posted : December 24, 2014
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of New Mexico

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hantavirus Infections
Interventions: Drug: Methylprednisolone
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Active Active drug
Placebo Placebo group

Participant Flow:   Overall Study
    Active   Placebo
STARTED   32   34 
COMPLETED   32   34 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Active Active drug
Placebo Placebo group
Total Total of all reporting groups

Baseline Measures
   Active   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   34   66 
[Units: Participants]
<=18 years   3   6   9 
Between 18 and 65 years   28   27   55 
>=65 years   1   1   2 
[Units: Years]
Mean (Standard Deviation)
 40.94  (15.49)   36.26  (15.13)   38.53  (15.37) 
[Units: Participants]
Female   10   10   20 
Male   22   24   46 
Region of Enrollment 
[Units: Participants]
Chile   32   34   66 

  Outcome Measures

1.  Primary:   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 ]

2.  Primary:   Number of Participants With SAEs   [ Time Frame: 6 months ]

3.  Secondary:   Number of Participants on Extracorporeal Membrane Oxygenation (ECMO)   [ Time Frame: 6 months ]

4.  Secondary:   Duration of ICU Stays   [ Time Frame: 6 months ]

5.  Secondary:   Duration of Hospital Stay in Days   [ Time Frame: 6 months ]

6.  Secondary:   Duration of Shock and/or Pressor/Inotropic Support   [ Time Frame: 6 months ]

7.  Secondary:   Number of Participants Intubated and Placed on a Ventilator After Study Entry.   [ Time Frame: 6 months ]

8.  Secondary:   Number of Participants Who Developed Refractory Shock Despite Fluid Resuscitation After Study Entry   [ Time Frame: 6 months ]

9.  Secondary:   Length of Time on a Ventilator   [ Time Frame: 6 months ]

10.  Secondary:   Development of Serum Creatinine Greater Than or Equal to 3.0 mg/dL After Study Entry   [ Time Frame: 6 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
While the study reached the target accrual of 60 confirmed cases, it was not powered to detect a difference in mortality. Higher disease severity in the placebo group at entry complicated both the efficacy and safety analyses.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Gregory Mertz, MD
Organization: UNewMexico
phone: 5059808601
e-mail: gmertz@salud.unm.edu

Publications of Results:

Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT00128180     History of Changes
Other Study ID Numbers: 01-010
U19 A1045452
First Submitted: August 5, 2005
First Posted: August 9, 2005
Results First Submitted: December 5, 2011
Results First Posted: July 10, 2012
Last Update Posted: December 24, 2014