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

Study Overview
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Brief Summary
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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.

Official Title
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A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients

Conditions
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Influenza

Intervention / Treatment
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* Drug: Oseltamivir
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oseltamivir<br> | Drug: Oseltamivir<br>* Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.<br>* Other names: Tamiflu;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population | 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. | From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population | 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. | From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) | 
| Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population | 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. | From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) | 
| Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population | 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. | From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) | 
| Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population | 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. | From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) | 
| Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population | 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. | From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) | 
| Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population | 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. | From baseline up to 28 days after the last dose of study drug (maximum up to 112 days) |