Text Size

Efficacy of Methylprednisolone for Hantavirus Cardiopulmonary Syndrome

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00128180
First received: August 5, 2005
Last updated: July 9, 2012
Last verified: December 2011
History of Changes
Results First Received: December 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hantavirus Infections
Interventions: Drug: Methylprednisolone
Drug: Placebo

  Participant Flow
  Hide 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
  Description
Active Active drug
Placebo Placebo group

Participant Flow:   Overall Study
    Active     Placebo  
STARTED     32     34  
COMPLETED     32     34  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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

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



  Outcome Measures
  Show All 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 ]
  Show Outcome Measure 1

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

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

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

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

Measure Type Secondary
Measure Title Duration of Hospital Stay in Days
Measure Description Days
Time Frame 6 months  
Safety Issue No  

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.
Per protocol, efficacy analysis was limited to participants with confirmed hantairus infection.

Reporting Groups
  Description
Active Active drug
Placebo Placebo group

Measured Values
    Active     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  30     30  
Duration of Hospital Stay in Days  
[units: days]
Mean ± Standard Deviation 		  8.90  ± 6.08     10.67  ± 8.93  

No statistical analysis provided for Duration of Hospital Stay in Days



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

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

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

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

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


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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


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.  


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


No publications provided


Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT00128180     History of Changes
Other Study ID Numbers: 01-010, U19 A1045452
Study First Received: August 5, 2005
Results First Received: December 5, 2011
Last Updated: July 9, 2012
Health Authority: Chile: Instituto de Salud Publica de Chile