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A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants

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ClinicalTrials.gov Identifier: NCT00412737
Recruitment Status : Completed
First Posted : December 18, 2006
Results First Posted : September 9, 2009
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE December 15, 2006
First Posted Date  ICMJE December 18, 2006
Results First Submitted Date  ICMJE August 3, 2009
Results First Posted Date  ICMJE September 9, 2009
Last Update Posted Date June 10, 2016
Study Start Date  ICMJE January 2007
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2016)
Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population [ Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) ]
Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than [>] 37.2 degrees Celsius [°C]) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum hemagglutination inhibition (HAI) titers measured from baseline to any point during the study.
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2006)
Percentage of subjects with laboratory-confirmed clinical influenza.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2016)
  • Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population [ Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) ]
    Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.
  • Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population [ Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) ]
    Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.
  • Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population [ Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) ]
    RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.
  • Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population [ Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) ]
    RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.
  • Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population [ Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) ]
    RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.
  • Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population [ Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) ]
    RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2006)
Efficacy: Percentage of subjects with asymptomatic laboratory-confirmed influenza; percentage with influenza-like illness; incidence of secondary illnesses. Safety: AEs, laboratory safety, vital signs.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants
Official Title  ICMJE A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients
Brief Summary This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Drug: Oseltamivir
    Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
    Other Name: Tamiflu
  • Drug: Placebo
    Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
Study Arms  ICMJE
  • Experimental: Oseltamivir
    Intervention: Drug: Oseltamivir
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Ison MG, Szakaly P, Shapira MY, Kriván G, Nist A, Dutkowski R. Efficacy and safety of oral oseltamivir for influenza prophylaxis in transplant recipients. Antivir Ther. 2012;17(6):955-64. doi: 10.3851/IMP2192. Epub 2012 Jun 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2009)
477
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Negative rapid diagnostic test for influenza at baseline;
  • Immunocompromised participant (liver and/or kidney recipient or allogenic hematopoietic stem cell transplant).

Exclusion Criteria:

  • Symptoms suggestive of influenza-like illness; but not limited to fever, cough, or nasal congestion;
  • Influenza vaccination in 6 weeks prior to randomization;
  • Positive rapid diagnostic test for influenza;
  • Solid organ transplant within 6 months of randomization;
  • Antiviral treatment for influenza in 2 weeks prior to randomization.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Czech Republic,   Estonia,   France,   Germany,   Hungary,   Israel,   Italy,   Lithuania,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00412737
Other Study ID Numbers  ICMJE NV20235
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP