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TCAD vs. Monotherapy for Influenza A in Immunocompromised Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Boeckh, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00867139
First received: March 20, 2009
Last updated: August 8, 2013
Last verified: August 2013
Results First Received: December 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Influenza
Interventions: Drug: TCAD
Drug: Zanamivir or Oseltamivir
Other: Open label treatment with TCAD

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from subjects who had a hematopoietic cell transplantation (HCT) within 2 years or combination chemotherapy within 3 months, those with chronic graft-versus-host disease (GVHD) requiring systemic treatment after 2 years post HCT, or with GVHD taking at least 2 immunosuppressive drugs between February - September, 2009

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
TCAD This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
Neuraminidase Inhibitor Monotherapy This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
Open-labeled TCAD This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.

Participant Flow:   Overall Study
    TCAD     Neuraminidase Inhibitor Monotherapy     Open-labeled TCAD  
STARTED     2     1     4  
COMPLETED     2     1     3 [1]
NOT COMPLETED     0     0     1  
[1] One open-labeled patient withdrew on day 5.



  Baseline Characteristics
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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
  Description
TCAD This substudy was a randomized study comparing TCAD therapy and OSL monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
Neuraminidase Inhibitor Monotheraphy Neuraminidase inhibitors include zanamivir and oseltamivir phosphate in this study.
Open-Labeled TCAD Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received open-label TCAD.
Total Total of all reporting groups

Baseline Measures
    TCAD     Neuraminidase Inhibitor Monotheraphy     Open-Labeled TCAD     Total  
Number of Participants  
[units: participants]
  2     1     4     7  
Age  
[units: participants]
       
<=18 years     0     1     2     3  
Between 18 and 65 years     1     0     2     3  
>=65 years     1     0     0     1  
Age  
[units: years]
Mean ± Standard Deviation
  59.5  ± 17.7     17  ± 0     29.5  ± 26.0     36.3  ± 25.7  
Gender  
[units: participants]
       
Female     1     1     2     4  
Male     1     0     2     3  
Region of Enrollment  
[units: participants]
       
United States     2     1     4     7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AEs), Drug Specific AEs or AEs Resulting in Treatment Interruption   [ Time Frame: 30 days after the final dose of study drug ]

2.  Secondary:   Number of Participants With Viral Load Decrease as a Function of Time   [ Time Frame: baseline and 28 days ]

3.  Secondary:   Number of Patients Not Shedding Virus at Day 5 +/-1 and Day 10 +/- 1   [ Time Frame: 10 days ]

4.  Secondary:   Number of Participants With Viral Resistance as a Function of Drug Exposure   [ Time Frame: 28 days ]

5.  Secondary:   Duration of Symptoms   [ Time Frame: from baseline up to 28 days ]

6.  Secondary:   Frequency of Confirmed Pneumonia   [ Time Frame: 58 days ]

7.  Secondary:   Duration of Hospitalization   [ Time Frame: from baseline up to 58 days ]

8.  Secondary:   Days on Supplemental Oxygen   [ Time Frame: 58 days ]

9.  Secondary:   Number of Participants With ICU Admissions   [ Time Frame: baseline and up to 58 days ]

10.  Secondary:   Number of Participants With Intubations   [ Time Frame: 58 days ]

11.  Secondary:   Number of Deaths   [ Time Frame: 58 days ]

12.  Secondary:   Pharmacokinetics (AUC0-last) of TCAD   [ Time Frame: 5 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Study was terminated. Limitations of this study include: small sample size pilot study; inability to enroll the projected number of patients for full analysis before the study was terminated.


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


Results Point of Contact:  
Name/Title: Michael Boeckh MD
Organization: FHCRC
phone: 206 667 6706
e-mail: mboeckh@fhcrc.org


No publications provided


Responsible Party: Michael Boeckh, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00867139     History of Changes
Obsolete Identifiers: NCT00865800
Other Study ID Numbers: 2323.00, 6895
Study First Received: March 20, 2009
Results First Received: December 21, 2012
Last Updated: August 8, 2013
Health Authority: United States: Institutional Review Board